28. 全身性アミロイドーシス [臨床試験数:212,薬物数:234(DrugBank:72),標的遺伝子数:54,標的パスウェイ数:170

Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloidosis", "Familial amyloid polyneuropathy", "Senile transthyretin amyloidosis", "Senile TTR amyloidosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-000713-32-DE23/12/202009/09/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis stage IIIa cardiac AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
267Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
2EUCTR2019-004254-28-DE23/12/202009/09/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis stage IIIb cardiac AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
3NCT04617925December 202020/10/2020A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL AmyloidosisA Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL AmyloidosisAL AmyloidosisDrug: Belantamab mafodotinEuropean Myeloma NetworkGlaxoSmithKlineNot yet recruiting18 YearsN/AAll35Phase 2Greece
4EUCTR2019-004254-28-GB30/11/202010/09/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis Stage IIIb cardiac AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Germany;Japan
5EUCTR2020-000713-32-GR27/11/202005/10/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIa AL Amyloidosis stage IIIa cardiac AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
267Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-004254-28-GR27/11/202005/10/2020A double-blind study to evaluate the effectiveness and safety of CAEL-101 in patients with AL amyloidosis.A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis stage IIIb cardiac AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10007509Term: Cardiac amyloidosisSystem Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: CAEL-101
INN or Proposed INN: Not assigned
Other descriptive name: CHIMERIC FIBRIL-REACTIVE IGG1K MONOCLONAL ANTIBODY 11-1F4
Caelum Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
111Phase 3United States;Greece;Spain;Israel;Russian Federation;Italy;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Japan
7EUCTR2018-004670-10-BG25/11/202004/08/2020Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN)
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AG10
Product Code: AG10 HCl
INN or Proposed INN: AG10 HCl
Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID
Eidos Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands;New Zealand
8NCT04316442November 13, 202016/3/2020Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL AmyloidosisA Phase 1, Open-Label, Dose-Escalation Study of the Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Systemic AL AmyloidosisLight Chain (AL) AmyloidosisBiological: STI-6129Sorrento Therapeutics, Inc.NULLRecruiting18 YearsN/AAll60Phase 1United States
9NCT04270175November 202012/2/2020Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabDaratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabAmyloid;AL Amyloidosis;Refractory AL AmyloidosisDrug: Daratumumab;Drug: Pomalidomide;Drug: DexamethasoneWeill Medical College of Cornell UniversityJanssen Scientific Affairs, LLCNot yet recruiting18 YearsN/AAll21Phase 2United States
10NCT04418024October 21, 202022/5/2020Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid PolyneurophathyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects With Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial)Transthyretin-Related (ATTR) Familial Amyloid PolyneuropathyDrug: AG10;Drug: PlaceboEidos TherapeuticsNULLRecruiting18 Years90 YearsAll145Phase 3United States;Canada;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-004670-10-DE28/09/202025/05/2020Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN)
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AG10
Product Code: AG10 HCl
INN or Proposed INN: AG10 HCl
Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID
Eidos Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands;New Zealand
12EUCTR2018-004670-10-PT31/08/202004/06/2020Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN)
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AG10
Product Code: AG10 HCl
INN or Proposed INN: AG10 HCl
Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID
Eidos Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3Portugal;New Zealand;Taiwan;Turkey;Russian Federation;Spain;Italy;France;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Netherlands
13NCT04504825August 25, 202020/7/2020A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)Caelum BiosciencesIQVIA BiotechRecruiting18 YearsN/AAll111Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom
14NCT04512235August 25, 202010/8/2020A Study to Evaluate the Effectiveness and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD)Caelum BiosciencesIQVIA BiotechRecruiting18 YearsN/AAll267Phase 3United States;Australia;Belgium;Canada;France;Germany;Greece;Israel;Italy;Japan;Poland;Russian Federation;Spain;United Kingdom
15NCT04115956August 6, 202029/8/2019A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) AmyloidosisAn Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of TherapyAL AmyloidosisDrug: Melphalan-Flufenamide (Melflufen);Drug: DexamethasoneOncopeptides ABPRA Health SciencesRecruiting18 YearsN/AAll46Phase 1/Phase 2United States;Czechia;France;Germany;Greece;Israel;Italy;Norway;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04392960July 22, 202027/2/2020Novel Imaging Tools in Newly-diagnosed Patients With Cardiac AL AmyloidosisMolecular, Magnetic Resonance, and Echocardiographic Imaging Combined With Biomarkers of Cardiac and Clonal Disease to Predict Survival and Assess Response to Therapy in Cardiac AL AmyloidosisAL AmyloidosisDrug: [18F]FlorbetabenIRCCS Policlinico S. MatteoNULLRecruiting18 YearsN/AAll69N/AItaly
17EUCTR2019-001698-10-GR17/07/202011/06/2020Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Greece;Spain;Ireland;Turkey;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Cyprus;Australia;Germany;Netherlands;New Zealand;Japan;Sweden
18EUCTR2018-004670-10-HU07/07/202012/05/2020Study of the Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN)A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of AG10 in Subjects with Symptomatic Transthyretin Amyloid Polyneuropathy (ATTRibute-PN Trial) - Efficacy and Safety of AG10 in participants with Transthyretin Amyloid Polyneuropathy (ATTR-PN) Symptomatic Transthyretin Amyloid Polineuropathy (ATTR-PN)
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AG10
Product Code: AG10 HCl
INN or Proposed INN: AG10 HCl
Other descriptive name: 3-(3-(3,5-DIMETHYL-1H-PYRAZOL-4-YL)PROPOXY)-4-FLUOROBENZOIC ACID
Eidos Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Phase 3Portugal;Taiwan;Spain;Turkey;Russian Federation;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Bulgaria;Germany;Netherlands;New Zealand
19EUCTR2019-001698-10-SE13/05/202024/02/2020Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
20EUCTR2019-001698-10-DE29/03/202024/10/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-001698-10-PT19/03/202018/10/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Spain;Ireland;Chile;Switzerland;Italy;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden;Israel;France;Estonia;Greece;Canada
22NCT04304144March 18, 202028/2/2020A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisCAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisAL AmyloidosisDrug: CAEL-101Caelum BiosciencesNULLEnrolling by invitation18 YearsN/AAll25Phase 2United States
23EUCTR2019-001698-10-GB06/03/202018/10/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
24EUCTR2019-001698-10-IT27/02/202003/12/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ION-682884
Product Code: ION-682884
INN or Proposed INN: ION-682884
Other descriptive name: ION-682884
Product Name: inotersen
Product Code: ISIS 420915
INN or Proposed INN: INOTERSEN
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3Portugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Latvia;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;Japan;New Zealand;Sweden
25EUCTR2019-001698-10-ES14/02/202002/12/2019Study to determine the effectiveness and safety of ION-682884 in patients with Hereditary Transthyretin-Mediated Amyloid PolyneuropathyA Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Hereditary Transthyretin-Mediated Amyloid Polyneuropathy - NEURO – TTRANSFORM Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
MedDRA version: 20.0 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Taiwan;Estonia;Greece;Spain;Ireland;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Cyprus;Australia;Netherlands;Latvia;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-002761-19-ES05/02/202009/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis.Patients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy
27EUCTR2018-004333-33-FR23/01/202002/12/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
28NCT04612582January 1, 202015/6/2020Comparison of BTD and BCD Based Regimens in the Treatment of AL AmyloidosisA Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial(BTD-CHINA-TRIAL)Immunoglobulin Light-Chain AmyloidosisDrug: Thalidomide;Drug: CyclophosphamideGuangdong Provincial People's HospitalNULLRecruiting18 Years80 YearsAll70Phase 4China
29EUCTR2018-002761-19-GR03/12/201915/11/2019 It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis Patients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
46 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom
30EUCTR2018-002761-19-NO15/11/201901/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2United States;France;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-002761-19-PL24/10/201907/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
32EUCTR2018-002761-19-CZ21/10/201931/07/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom
33EUCTR2018-004333-33-IT01/08/201928/04/2020Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis - EMN22/54767414AMY2005 Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
INN or Proposed INN: DARATUMUMAB
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
Product Name: Decadron
Product Code: H02AB02 Desametasone
INN or Proposed INN: DEXAMETHASONE
Other descriptive name: Dexamethasone
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
34EUCTR2018-004333-33-NL24/07/201908/07/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noGreece;Netherlands;Italy
35EUCTR2018-004333-33-GR08/07/201905/06/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
INN or Proposed INN: DARATUMUMAB
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Greece;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2017-002210-31-DE31/05/201924/01/2019An allocation by random phase II/III trial of doxycycline in comparison to standard therapy in newly-diagnosed cardiac AL amyloidosis patients with bortezomib-based therapyA randomized phase II/III trial of doxycycline vs. standard supportive therapy in newly-diagnosed cardiac AL amyloidosis patients undergoing bortezomib-based therapy - ReDox Light chain (AL) amyloidosis is a protein conformational disease, caused by a small bone marrow plasma cell clone producing light chains (LCs) that undergo conformational changes, aggregate and deposit in tissues in the form of amyloid fibrils. This process causes dysfunction of the organs involved and leads to death if not effectively treated.;Therapeutic area: Not possible to specifyAmyloid Center - Biotechnology Research Laboratories Policlinico San MatteoNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noCanada;Turkey;Germany
37NCT04298372February 20, 20193/12/2019Frontline Lenalidomide for AL Amyloidosis Involving MyocardiumFrontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of LenalidomideAmyloidosis CardiacDrug: Lenalidomide 25mgSeoul National University HospitalNULLRecruiting19 Years99 YearsAll30Phase 3Korea, Republic of
38NCT03474458February 11, 201916/3/2018A Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based TherapyA Randomized Phase II/III Trial of Doxycycline vs. Standard Supportive Therapy in Newly-diagnosed Cardiac AL Amyloidosis Patients Undergoing Bortezomib-based TherapyCardiac AL AmyloidosisDrug: Doxycycline;Drug: Standard of care therapyIRCCS Policlinico S. MatteoNULLRecruiting18 YearsN/AAll120Phase 2/Phase 3Canada;France;Germany;Greece;Italy;Spain;Turkey;United Kingdom
39EUCTR2016-001737-27-GB08/10/201811/01/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
40NCT03678259October 1, 201830/7/2018124I-p5+14 Injection Safety in Subjects With Systemic AmyloidosisEvaluation of 124I-p5+14 Injection as an Imaging Agent for the Detection of Systemic AmyloidosisSystemic AmyloidosisDrug: 124I-p5+14 InjectionUniversity of Tennessee Graduate School of MedicineNULLRecruiting18 YearsN/AAll43Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2016-001737-27-PL06/09/201816/07/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
42EUCTR2016-001737-27-DK22/08/201804/06/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Australia;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
43NCT03618537August 2, 20182/8/2018Ixazomib Maintenance Study in Patients With AL AmyloidosisIxazomib Maintenance Following Initial Therapy in Patients With Immunoglobulin Light Chain (AL) AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: DexamethasoneMemorial Sloan Kettering Cancer CenterTufts Medical Center;Vanderbilt University Medical CenterRecruiting18 YearsN/AAll47Phase 2United States
44JPRN-JapicCTI-18392917/7/201813/04/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AmyloidosisIntervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab
INN of the intervention : -
Dosage And administration of the intervention : Participants will receive dexamethasone (20mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Control intervention name : Cyclophosphamide, Bortezomib, dexamethasone
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive dexamethasone (40milligrams [mg] orally or intravenous [IV]dose), followed by cyclophosphamide (300milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Janssen Pharmaceutical K.K.NULLcomplete20BOTH370Phase 3Japan, Asia except Japan, North America, Europe
45EUCTR2016-001737-27-SE07/05/201820/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2017-005115-13-ES25/04/201819/02/2018A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Ionis Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
164Phase 3United Kingdom;New Zealand;Italy;Portugal;France;United States;Argentina;Brazil;Spain;Germany
47EUCTR2017-005115-13-PT23/04/201806/03/2018A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Other descriptive name: Inotersen
Ionis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
164Phase 3France;United States;Portugal;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
48EUCTR2016-001737-27-DE16/04/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
49EUCTR2016-001737-27-GR16/04/201822/03/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
50EUCTR2016-001737-27-NL15/03/201829/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03130348March 15, 201821/4/2017Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain AmyloidosisPhase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain AmyloidosisAmyloidosis;Immunoglobulin Light Chain DepositionDrug: Bortezomib;Drug: Dexamethasone;Drug: Ibrutinib;Other: Laboratory Biomarker AnalysisMayo ClinicNational Cancer Institute (NCI)Withdrawn18 YearsN/AAll0Phase 2United States
52NCT03499808March 8, 20189/4/2018S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary AmyloidosisA Phase II Study of Isatuximab (SAR650984) (NSC-795145) for Patients With Previously Treated AL AmyloidosisAmorphous, Eosinophilic, and Acellular Deposit;Constipation;Diarrhea;Early Satiety;Gastrointestinal Hemorrhage;Hepatomegaly;Lymphadenopathy;Macroglossia;Nausea;Primary Systemic Amyloidosis;Purpura;Recurrent Primary Amyloidosis;Refractory Primary AmyloidosisBiological: Isatuximab;Other: Laboratory Biomarker AnalysisSouthwest Oncology GroupNational Cancer Institute (NCI)Active, not recruiting18 YearsN/AAll43Phase 2United States
53EUCTR2016-004664-18-DE09/02/201824/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
54NCT03283917February 7, 201813/9/2017Daratumumab, Ixazomib, and Dexamethasone in AL AmyloidosisA Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL AmyloidosisNewly Diagnosed Primary Amyloidosis;Recurrent Primary Amyloidosis;Refractory Primary AmyloidosisBiological: Daratumumab;Drug: Dexamethasone;Drug: IxazomibM.D. Anderson Cancer CenterJanssen Pharmaceuticals;Takeda PharmaceuticalRecruiting18 YearsN/AAll20Phase 1United States
55EUCTR2016-001737-27-ES06/02/201823/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2016-001737-27-HU25/01/201828/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
57EUCTR2016-001737-27-BE16/01/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
58NCT02994784January 8, 201818/11/2016Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis PatientsA Phase II Single-Center, Open-Label, Safety and Efficacy Study of Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients Undergoing Autologous Stem Cell TransplantationAmyloidosis; SystemicDrug: Propylene Glycol-Free Melphalan HydrochlorideBoston Medical CenterSpectrum Pharmaceuticals, IncRecruiting18 YearsN/AAll43Phase 2United States
59NCT03315026December 14, 201713/10/2017Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL AmyloidosisPhase II Study of Interleukin 6 Blockade With Siltuximab to Decrease Symptom Burden in Patients Age 60-75 Undergoing Autologous Stem Cell Transplantation for Multiple Myeloma and AL AmyloidosisMultiple Myeloma;AL AmyloidosisDrug: Siltuximab;Behavioral: The M.D. Anderson Symptom Inventory (MDASI)Memorial Sloan Kettering Cancer CenterJanssen Scientific Affairs, LLCActive, not recruiting60 Years75 YearsAll30Phase 2United States
60EUCTR2016-004664-18-AT07/11/201720/09/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Australia;Austria;Israel;Germany;Italy;United Kingdom;United States;Greece;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03201965October 5, 201727/6/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL AmyloidosisAmyloidosisDrug: Cyclophosphamide;Drug: Bortezomib;Drug: Dexamethasone, 40 mg;Drug: DaratumumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll416Phase 3United States;Australia;Belgium;Brazil;Canada;China;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;United Kingdom;Romania
62ChiCTR-IPR-170126372017-10-012017-09-11Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosisProspective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis type AL amyloidosisGroup 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);Guangdong General HospitalNULLPending1875BothGroup 1:35;Group 2:35;China
63EUCTR2016-004664-18-GR27/09/201702/06/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
64NCT03252600August 25, 201724/7/2017Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary AmyloidosisA Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL AmyloidosisRecurrent Primary AmyloidosisDrug: Cyclophosphamide;Drug: Dexamethasone;Biological: Elotuzumab;Other: Laboratory Biomarker Analysis;Drug: Lenalidomide;Other: Pharmacological StudyBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI);Bristol-Myers Squibb;Multiple Myeloma Research ConsortiumRecruiting18 YearsN/AAll53Phase 2United States
65EUCTR2016-004664-18-GB08/08/201709/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2016-004664-18-ES31/07/201729/05/2017A study to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO) The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
67NCT03154047June 14, 201728/4/2017Study in Subjects With Light Chain (AL) AmyloidosisA Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects With Light Chain (AL) Amyloidosis Who Were Previously Enrolled in Study NEOD001-201 (PRONTO)AL AmyloidosisDrug: NEOD001Prothena Therapeutics Ltd.NULLTerminated18 YearsN/AAll80Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
68NCT03236792June 12, 201720/7/2017Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL AmyloidosisPhase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: Cyclophosphamide;Drug: DexamethasoneIcahn School of Medicine at Mount SinaiMillennium Pharmaceuticals, Inc.Recruiting18 YearsN/AAll30Phase 1/Phase 2United States
69NCT02841033March 20, 201714/6/2016Daratumumab for the Treatment of Patients With AL AmyloidosisA Phase I-II Trial of Daratumumab for the Treatment of Patients With AL AmyloidosisAL AmyloidosisDrug: daratumumabBoston Medical CenterJanssen PharmaceuticalsCompleted18 YearsN/AAll25Phase 1/Phase 2United States
70NCT03000660January 201712/12/2016Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL AmyloidosisA Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL AmyloidosisAL AmyloidosisDrug: Venetoclax;Drug: DexamethasoneTufts Medical CenterNULLTerminated18 YearsN/AAll3Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2016-000276-23-GB06/12/201611/07/2016Study to look at the affect of anti-SAP treatment in patients with cardiac amyloidosis A multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosis Systemic amyloidosis
MedDRA version: 20.0 Level: SOC Classification code 10021428 Term: Immune system disorders System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;United Kingdom
72NCT02816476September 201622/6/2016Daratumumab Therapy for Patients With Refractory or Relapsed AL AmyloidosisA Multicentre Open Label Phase II Study of Daratumumab in AL Amyloidosis Patients Not in VGPR or BetterAmyloidosisDrug: DaratumumabUniversity Hospital, LimogesNULLActive, not recruiting18 YearsN/AAll40Phase 2France;Italy
73EUCTR2015-004318-14-AT07/07/201622/08/2016A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2France;United States;Greece;Spain;Australia;Austria;Israel;Germany;Italy;United Kingdom
74EUCTR2015-005333-49-GB30/06/201604/04/2016A study to look at the long-term efficacy and safety of ALN-TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Multicenter, Multinational, Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of Revusiran in Patients with Transthyretin-mediated Familial Amyloidotic Cardiomyopathy Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.1Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Revusiran
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Mexico;Canada;Spain;Brazil;Belgium;Germany;Italy;United Kingdom;Sweden
75EUCTR2015-004318-14-DE13/06/201626/11/2015A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Greece;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2016-000287-42-FR18/05/201608/06/2016Amyloidosis Patients traitmentA Multicentre Open label Phase II study of Daratumumab in AL AmyloidosisPatients not in VGPR or Better - AMYDARA AL Amyloidosis
MedDRA version: 19.0Level: HLGTClassification code 10035227Term: Plasma cell neoplasmsSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Product Name: HuMax-CD38
INN or Proposed INN: DARATUMUMAB
CHU de LimogesNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France
77NCT02603172May 12, 20169/11/2015A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic AmyloidosisA Three-part Open-label, Non-randomised, Dose-escalation Study to Investigate the Safety and Tolerability of GSK3039294 Administered as a Single Dose to Healthy Volunteers, and as Repeat Dose to Healthy Volunteers and Patients With Systemic AmyloidosisAmyloidosisDrug: GSK3039294GlaxoSmithKlineNULLTerminated18 Years70 YearsAll23Phase 1United Kingdom
78ChiCTR-IPR-160084222016-05-052016-05-08Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL)Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL) primary systemic amyloidosis (AL)the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD);the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD) ;People's Hospital, Beijing UniversityNULLRecruiting1875Boththe first group:60;the second group:60;China
79EUCTR2015-004318-14-GR21/04/201611/02/2016A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 18.1Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom
80EUCTR2015-004318-14-ES10/03/201618/03/2016A study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis or primary systemic amyloidosis, involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains by plasma cells results in both soluble, aggregated forms of light chains and insoluble, fibrillar deposits of abnormal AL protein (amyloid), in the tissues and organs of individuals with AL amyloidosis.
MedDRA version: 18.1Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT02632786March 20169/12/2015The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) AmyloidosisA Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac DysfunctionAL AmyloidosisDrug: NEOD001;Drug: PlaceboProthena Therapeutics Ltd.NULLCompleted18 YearsN/AAll129Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
82EUCTR2015-004318-14-GB05/02/201627/11/2015A study to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart.A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, aggregated forms of light chains and insoluble,fibrillar deposits of abnormal AL protein (amyloid),in the tissues and organs. This can cause a range of symptoms and organ dysfunction including cardiac,renal,and hepatic dysfunction,gastrointestinal involvement and neuropathy and macroglossia
MedDRA version: 20.0Level: PTClassification code 10036673Term: Primary amyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
INN or Proposed INN: N/A
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Prothena Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
129Phase 2United States;France;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
83NCT02613182February 201618/11/2015Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) AmyloidosisOpen-label Extension Study to Evaluate the Long-term Safety and Tolerability of NEOD001 in Subjects With Light Chain (AL) AmyloidosisAL AmyloidosisDrug: NEOD001Prothena Therapeutics Ltd.NULLTerminatedN/AN/AAll34Phase 2United States
84NCT02627820January 201619/11/2015The Effect of an Antisense Oligonucleotide to Lower Transthyretin (TTR) Levels on the Progression of -Wild-type TTR Involving the HeartAn 18 Month Open Label Study Of The Tolerability And Efficacy Of An Antisense Oligonucleotide In Patients With Wild-Type Transthyretin Amyloid Cardiomyopathy (Senile Systemic Amyloidosis)AmyloidosisDrug: Isis 420915/GSK 299872Brigham and Women's HospitalGlaxoSmithKline;Ionis Pharmaceuticals, Inc.Withdrawn50 Years90 YearsBoth0Phase 2NULL
85EUCTR2013-004561-13-ES28/12/201530/10/2015Not availableAn Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 18.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Isis Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
195Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-002231-18-GB01/12/201523/09/2015A Phase I/IIa (early phase) Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL AmyloidosisA Phase I/IIa Study of Targeted Radiotherapy alone for Stem Cell Transplant Conditioning in Systemic AL Amyloidosis - Targeted Radiotherapy for AL-Amyloidosis –‘TRALA’ AL-Amyloidosis
MedDRA version: 18.0Level: LLTClassification code 10024460Term: Light chain disease myeloma associatedSystem Organ Class: 100000004864;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CHX-A-DTPA-Anti-CD66
INN or Proposed INN: CHX A-DTPA anti-CD66 antibody
Product Name: Indium­ 111 ­labelled Anti­-CD66
INN or Proposed INN: Indium 111-radiolabelled anti-CD66
Product Name: yttrium-90 radiolabelled anti-CD66 antibody
INN or Proposed INN: Yttrium­90 radiolabelled anti­CD66
University Southampton Hospital NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
18Phase 1/2United Kingdom
87NCT02545907October 201527/8/2015A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL AmyloidosisA Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL AmyloidosisAmyloidosisDrug: Carfilzomib;Drug: Thalidomide;Drug: DexamethasoneUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth36Phase 1/Phase 2United Kingdom
88EUCTR2013-004561-13-DE22/09/201515/06/2015Not availableAn Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Ionis Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
135Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
89EUCTR2013-004561-13-GB23/07/201509/02/2015Not availableAn Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 19.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Ionis Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Germany;Italy;United Kingdom
90EUCTR2014-003835-20-DE24/06/201502/12/2014A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 19.0Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT02489500June 20159/3/2015Trial of High Dose Melphalan/Stem Cell Transplant With or Without BortezomibPhase III Trial of High-dose Melphalan and Stem Cell Transplantation Versus High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL AmyloidosisAL AmyloidosisDrug: Bortezomib;Drug: Melphalan;Drug: Neupogen;Procedure: Stem Cell Collection;Procedure: Stem cell infusionBoston Medical CenterNULLTerminated18 YearsN/AAll3Phase 3United States
92EUCTR2014-003835-20-SE20/05/201527/11/2014A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 19.0Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Canada;Brazil;Belgium;Spain;Germany;Italy;United Kingdom;Sweden
93EUCTR2014-003835-20-IT05/05/201509/03/2016A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA phase 3 Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled Study to evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) - na Trasthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 20.0Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
ALNYLAM PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Canada;Spain;Brazil;Belgium;Netherlands;Germany;United Kingdom;Italy;Sweden
94EUCTR2012-001831-30-BG23/04/201523/02/2015A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 Familial Amyloid Polyneuropathy
MedDRA version: 18.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Isis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2/3Portugal;France;United States;Mexico;Argentina;Brazil;Spain;Australia;Bulgaria;Germany;Italy;United Kingdom
95JPRN-UMIN0000197322015/03/3111/11/2015A randomised trial for the treatment of AL amyloidosis with the high dose Green Tea Extract. ligh chain amyloidosisstanderd therapy plus the high dose green tea therapy.
Drug: green tea extract powder
Pharmaceutical formulation: capsules
dose 2400 mg/d p.o. for 6 months every day
standerd therapy
Japanese Red Cross Medical Center, Division of HematologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2014-003835-20-ES30/03/201514/01/2015A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.0Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: NA
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Brazil;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Sweden
97EUCTR2014-003835-20-BE25/03/201503/02/2015A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heartA Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.1Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Mexico;Canada;Brazil;Spain;Belgium;Germany;Italy;United Kingdom;Sweden
98NCT02312206February 20152/12/2014The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) AmyloidosisPrimary Systemic (AL) AmyloidosisDrug: NEOD001;Other: PlaceboProthena Therapeutics Ltd.NULLTerminated18 YearsN/AAll260Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
99NCT01531751February 201511/1/2012High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal DiseaseAn Open Label Phase II Trial of Free Light Chain Removal by Extended High Cut-Off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End-Stage Renal Disease.Primary Amyloidosis of Light Chain TypeDevice: High Cut-off Hemodialysis;Drug: ChemotherapyIRCCS Policlinico S. MatteoNULLWithdrawn18 YearsN/AFemale0Phase 2Italy
100NCT02245867December 2, 201415/9/2014Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL AmyloidosisPhase Ia/Ib Study of Chimeric Fibril-Reactive Monoclonal Antibody 11-1F4 in Patients With AL AmyloidosisAmyloidosisDrug: Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4Andrew EisenbergerNULLCompleted21 YearsN/AAll31Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2014-003835-20-GB26/11/201417/10/2014A study to look at the efficacy and safety of ALN TTRSC in patients with an inherited condition that causes certain protein molecules to deposit in the heart.A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC) Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
MedDRA version: 18.1Level: PTClassification code 10016202Term: Familial amyloidosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-TTRSC
Product Code: ALN-TTRSC
INN or Proposed INN: Revusiran
Other descriptive name: ALN-51547
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Brazil;Belgium;Spain;Germany;Italy;France;United States;Canada;United Kingdom;Sweden
102NCT02207556October 1, 201423/7/2014Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis TrialDoxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis (DUAL) Trial: A Phase II Open Label Study of Oral Doxycycline Administered as an Adjunct to Plasma Cell Directed Therapy in Light Chain (AL) AmyloidosisPrimary Systemic AmyloidosisDrug: DoxycyclineMedical College of WisconsinNULLActive, not recruiting18 YearsN/AAll32Phase 2United States
103EUCTR2014-001586-27-ES25/07/201402/06/2014Study of SOM0226 in familial amyloid polyneuropathy (FAP) patients and asymptomatic carriers to evaluate protein stabilization activityStudy of SOM0226 in familial amyloid polyneuropathy (FAP) patients and asymptomatic carriers to evaluate protein stabilization activity Patients with familial amyloid polyneuropathy (FAP), asymptomatic carriers and healthy volunteers
MedDRA version: 17.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tasmar
INN or Proposed INN: TOLCAPONE
SOM Innovation Biotech SL (SOM Biotech)NULLNot RecruitingFemale: yes
Male: yes
Spain
104EUCTR2013-004561-13-PT04/07/201407/05/2014Not availableAn Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 20.0 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Ionis Pharmaceuticals, IncNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United States;Portugal;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
105NCT02191826July 20149/7/2014Study of SOM0226 in Familial Amyloid PolyneuropathyStudy of SOM0226 in Familial Amyloid Polyneuropathy (FAP) Patients and Asymptomatic Carriers to Evaluate Protein Stabilization ActivityFamilial Amyloid Polyneuropathy (FAP)Drug: SOM0226SOM Biotech SLHospital Vall d'HebronCompleted18 YearsN/ABoth17Phase 1/Phase 2Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT02175004June 201412/6/2014Open-Label Extension Assessing Long Term Safety and Efficacy of IONIS-TTR Rx in Familial Amyloid Polyneuropathy (FAP)An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (FAP)FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;AmyloidosisDrug: IONIS-TTR RxIonis Pharmaceuticals, Inc.NULLActive, not recruiting18 YearsN/AAll135Phase 3United States;Argentina;Brazil;France;Germany;Italy;Portugal;Spain;United Kingdom;New Zealand
107EUCTR2012-001831-30-ES25/04/201407/03/2014A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 Familial Amyloid Polyneuropathy
MedDRA version: 16.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Isis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2;Phase 3United States;France;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;United Kingdom;Italy
108EUCTR2013-004561-13-FR16/04/201417/06/2015Not availableAn Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 18.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Isis Pharmaceuticals, IncNULLNot RecruitingFemale: yes
Male: yes
195Phase 3United States;Portugal;France;Argentina;Spain;Brazil;Germany;United Kingdom;Italy
109NCT01807286January 20146/3/2013Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL AmyloidosisA Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase IMyelomaDrug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: QuestionnairesM.D. Anderson Cancer CenterCelgeneTerminated18 YearsN/ABoth3Phase 1United States
110EUCTR2010-022395-31-CZ01/10/201317/07/2013A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis.A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. AL Amyloidosis
MedDRA version: 16.1Level: HLGTClassification code 10035227Term: Plasma cell neoplasmsSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Trade Name: ALKERAN
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
Trade Name: FORTECORTIN
Product Name: dexamethasone
Product Code: A01AC02
INN or Proposed INN: DEXAMETHASONE
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111JPRN-UMIN0000123192013/09/1525/11/2013Imaging of systemic amyloidosis with 99mTc-aprotinin Cardiac amyloidosisWhole-body and cross sectional images will be obtained using a SPECT camera 90min after injection of 740MBq of 99mTc-aprotinin.Biopsy will be planned for the positive patients to confirm the image diagnosis.National Center for Global Health and MedicineNULLRecruiting20years-oldNot applicableMale and Female80Not selectedJapan
112EUCTR2012-001831-30-DE22/08/201329/05/2013A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 Familial Amyloid Polyneuropathy
MedDRA version: 19.0 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Ionis Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
135 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
113EUCTR2012-001831-30-IT04/07/201319/06/2013A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 Familial Amyloid Polyneuropathy
MedDRA version: 14.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Isis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2;Phase 3France;United States;Portugal;Spain;Brazil;Bulgaria;Germany;United Kingdom;Italy
114NCT01777243May 13, 201324/1/2013A Study to Evaluate the Safety of GSK2398852 When Co-administered With GSK2315698 in Patients With Systemic AmyloidosisA Single Dose First in Human Study of GSK2398852 Co-Administered With GSK2315698 in Patients With Systemic AmyloidosisAmyloidosisDrug: GSK2398852;Drug: GSK2315698GlaxoSmithKlineImperial College London;Heart Hospital;Royal Free Hospital NHS Foundation Trust;Quintiles, Inc.Completed18 Years70 YearsAll25Phase 1United Kingdom
115EUCTR2012-001831-30-GB22/04/201316/11/2012A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 Familial Amyloid Polyneuropathy
MedDRA version: 19.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Ionis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01849783April 4, 20136/5/2013Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple MyelomaSingle Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell MalignancyExtramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple MyelomaDrug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplantYogesh JethavaNational Cancer Institute (NCI)Active, not recruiting65 Years85 YearsAll41Phase 2United States
117NCT02015312April 201318/11/2013A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)A Randomised Trial for the Treatment of Cardiac AMyloid Light-chain Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL)Light Chain (AL) Amyloidosis;Cardiac InvolvementDrug: Epigallocatechin-3-gallate (EGCG);Drug: PlaceboFlorian MichelGerman Federal Ministry of Education and ResearchCompleted18 YearsN/AAll38Phase 2Germany
118NCT01737398March 15, 201327/11/2012Efficacy and Safety of Inotersen in Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)FAP;Familial Amyloid Polyneuropathy;TTR;Transthyretin;AmyloidosisDrug: Inotersen;Drug: PlaceboIonis Pharmaceuticals, Inc.NULLCompleted18 Years82 YearsAll173Phase 2/Phase 3United States;Argentina;Brazil;France;Germany;Italy;New Zealand;Portugal;Spain;United Kingdom;Bulgaria
119NCT01728259March 201313/11/2012First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDDPhase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition DiseaseLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: pomalidomide;Drug: bortezomib;Drug: dexamethasone;Other: Laboratory Biomarker AnalysisBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 YearsN/AAll36Phase 1United States;Canada;New Zealand
120EUCTR2012-001831-30-PT21/02/201320/11/2012A controlled study to assess the effectiveness and safety of study drug, ISIS 420915, in patients with Familial Amyloid PolyneuropathyA Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy - ISIS 420915-CS2 Familial Amyloid Polyneuropathy
MedDRA version: 19.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Ionis Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3France;United States;Portugal;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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121NCT01222260January 201314/10/2010Bendamustine and Dexamethasone in Patients With Relapsed AL AmyloidosisPhase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL AmyloidosisAL AmyloidosisDrug: Bendamustine;Drug: DexamethasoneColumbia UniversityCephalonCompleted18 YearsN/AAll40Phase 2United States
122EUCTR2010-022395-31-DE25/10/201218/10/2012Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone for untreated patients with systemic light-chain (AL) amyloidosisA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - AC-004-EU AL amyloidosis
MedDRA version: 14.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
Trade Name: Fortecortin
Product Name: Dexamethason
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
European Myeloma NetworkNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
123JPRN-UMIN0000083962012/08/0110/07/2012A randomized, double-blind, placebo-controlled trial of diflunisal on familial amyloid polyneuropathy patients of familial amyloid polyneuropathyDiflunisal, 500mg / day, PO, 1 year
Parse, 500mg / day, PO, 1 year
Department of Neurology, Faculty of Life Sciences, Kumamoto UniversityNULLComplete: follow-up complete18years-old65years-oldMale and Female1Phase 3Japan
124EUCTR2010-022395-31-ES13/06/201221/05/2012A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosisA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 14.1Level: HLGTClassification code 10035227Term: Plasma cell neoplasmsSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Other descriptive name: VELCADE
Trade Name: Dexamethasone
Product Name: Dexamethasone
Product Code: Dexametasone
Other descriptive name: DEXAMETHASONE
Trade Name: melphalan
Product Name: Melphalan
Product Code: melphalan
INN or Proposed INN: MELPHALAN
Trade Name: betamethasone
Product Name: Dexamethasone
INN or Proposed INN: oral drops solution
Other descriptive name: DEXAMETHASONE
Trade Name: melphalan
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
E.M.N. - EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Germany;Netherlands;Denmark;Norway;France;Spain;Italy;Greece;Sweden
125NCT01570387June 201227/2/2012A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisA Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisAL AmyloidosisDrug: Pomalidomide;Drug: DexamethasoneBoston Medical CenterCelgene CorporationCompleted18 YearsN/AAll27Phase 1/Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
126EUCTR2010-021445-42-BE10/05/201210/10/2011A study in which is investigated if the medicine bortezomib is effective in patietns with AL amylodosis.A multicenter, randomized phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis AL Amyloidosis
MedDRA version: 20.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
HOVON FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
127EUCTR2010-021445-42-DE09/05/201223/01/2012A study to investigated whether bortezomib is effective in patients with AL amyloidosisA multicenter, prospective study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL Amyloidosis AL Amyloidosis
MedDRA version: 17.0Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
Trade Name: Fortecortin
Product Name: Fortecortin
INN or Proposed INN: Dexamethasone
Trade Name: Fortecortin
Product Name: Fortecortin
INN or Proposed INN: Dexamethasone
HOVON FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Belgium;Netherlands;Germany
128EUCTR2010-022395-31-GR02/05/201202/04/2012N/AN/A - BMDex vs MDex for AL amyloidosis Primary Systemic (AL) Amyloidosis
MedDRA version: 14.1Level: HLGTClassification code 10035227Term: Plasma cell neoplasmsSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Trade Name: Dexaton
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
Trade Name: Dexaton
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia
129EUCTR2011-001787-22-IT02/05/201212/01/2012Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex Previously treated AL amyloidosis
MedDRA version: 14.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE
OSPEDALE POLICLINICO S. MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
130NCT01510613February 201211/1/2012Pomalidomide and Dexamethasone (PDex) in AL AmyloidosisAn Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis.Primary Amyloidosis of Light Chain TypeDrug: Pomalidomide and DexamethasoneIRCCS Policlinico S. MatteoNULLCompleted18 YearsN/AAll28Phase 2Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
131NCT01511263January 201210/1/2012Epigallocatechingallate (EGCG) in Cardiac AL AmyloidosisA Phase II Open-label Randomized Study of Dietary Supplement With Epigallocatechin Gallate (EGCG) to Improve Cardiac Dysfunction in Patients With AL Amyloidosis Who do Not Require Chemotherapy (EpiCardiAL)Primary Amyloidosis of Light Chain TypeDrug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias);Drug: Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCGIRCCS Policlinico S. MatteoNULLTerminated18 YearsN/AAll86Phase 2Italy
132EUCTR2010-022395-31-DK14/11/201109/06/2011A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 14.1Level: HLGTClassification code 10035227Term: Plasma cell neoplasmsSystem Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: VELCADE
Product Name: bortezomib
Product Name: Dexamethasone
Trade Name: Alkeran
Product Name: Melphalan
Product Name: Dexamethasone
Product Name: Melphalan
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
133JPRN-JapicCTI-11167807/11/201102/11/2011The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M TransthyretinThe Effect Of Transthyretin Stabilization, Safety, Tolerability, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin: A Phase 3, Open-Label(B3461010) Transthyretin Familial Amyloid PolyneuropathyIntervention name : tafamidis meglumine
INN of the intervention : tafamidis meglumine
Dosage And administration of the intervention : 20 mg QD
Control intervention name : null
Pfizer Japan Inc.NULL2075BOTH10Phase 3NULL
134JPRN-UMIN0000066042011/11/0124/10/2011Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis. To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.Patients receive oral melphalan 8 mg/m2 on days 1-4, bortezomib SC (IV) on days 1, 4, 8 and 11, and dexamethasone orally on days 1-2, 4-5 8-9 11 and 12. Treatment repeats every 4 weeks (28 days) for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
*The preventive medication on last medication day after the 28th is recommended in principle from acyclovir 200 or 400 mg/the bortezomib medication opening day of a day.
Moreover, when the symptoms of herpes are shown, the acyclovir or the rose cyclo building of a therapeutic amount is promptly prescribed for the patient.
Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of HematologyNULLComplete: follow-up complete20years-old65years-oldMale and Female21Phase 1,2Japan
135NCT01435655November 201113/9/2011The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M TransthyretinThe Effect On Transthyretin Stabilization, Safety, Tolerablity, Efficacy And Pharmacokinetics Of Orally Administered Tafamidis In Transthyretin Amyloid Polyneuropathy Patients With V30m Or Non-v30m Transthyretin: A Phase Iii, Open-label StudyTransthyretin Familial Amyloid PolyneuropathyDrug: tafamidisPfizerNULLCompleted20 Years75 YearsAll10Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
136NCT01406314October 13, 201126/7/2011SAP Depleter Dose Assessment Study in PatientsA Phase 1, Open Label, Dose Characteristic Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Intravenous and Subcutaneous Doses of GSK2315698A in Patients With Systemic AmyloidosisAmyloidosisDrug: GSK2315698GlaxoSmithKlineNULLCompleted18 Years80 YearsAll17Phase 1United Kingdom
137EUCTR2010-021445-42-NL31/08/201127/01/2011A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosisA multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis AL Amyloidosis
MedDRA version: 16.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
HOVON FoundationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
138NCT01383759June 24, 201127/6/2011Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisPilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisLight Chain Deposition Disease (LCDD or MIDD);Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD);Monoclonal Immunoglobulin Deposition Disease (MIDD);AmyloidosisDrug: Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/DexamethasoneMemorial Sloan Kettering Cancer CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll20N/AUnited States
139EUCTR2010-022395-31-SE10/06/201112/04/2011A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 13.1Level: HLGTClassification code 10035227Term: Plasma cell neoplasmsSystem Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: VELCADE
Product Name: Dexamethasone
Product Name: Melphalan
Product Name: Dexamethasone
Product Name: Melphalan
E.M.N. - EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Denmark;Spain;Italy;Greece;Sweden
140NCT01273844March 1, 20113/1/2011Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in ALAmyloidosisDrug: BortezomibZhi-Hong Liu, M.D.Soochow University;Nanjing Medical UniversityCompleted18 Years65 YearsAll21N/AChina
No.TrialIDDate_
enrollment
Date_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
141NCT01277016January 201110/1/2011A Trial for Systemic Light-chain (AL) AmyloidosisA Randomized Open-label Multicenter Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-chain (AL) AmyloidosisAL AmyloidosisDrug: BMDexEuropean Myeloma NetworkNULLCompleted18 YearsN/AAll110Phase 3Italy
142NCT01199562December 20108/9/2010Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell TransplantModified Preemptive CMV Management Strategy After Allogeneic Hematopoietic Cell Transplantation and Laboratory Correlation With Innate Immune FunctionHematopoietic/Lymphoid Cancer;Accelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Atypical Chronic Myeloid Leukemia, BCR-ABL Negative;Blastic Phase Chronic Myelogenous Leukemia;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Cytomegalovirus Infection;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Mycosis Fungoides/Sezary Syndrome;Stage I Small Lymphocytic Lymphoma;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage II Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Mycosis Fungoides/Sezary Syndrome;Stage III Small Lymphocytic Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom MacroglobulinemiaProcedure: infection prophylaxis and management;Other: laboratory biomarker analysis;Other: flow cytometry;Genetic: DNA analysis;Genetic: RNA analysis;Procedure: management of therapy complications;Drug: ganciclovir;Drug: valganciclovir;Drug: foscarnet sodium;Procedure: antiviral therapy;Genetic: polymerase chain reaction;Genetic: protein expression analysisCity of Hope Medical CenterNational Cancer Institute (NCI)Completed18 YearsN/AAll153United States
143NCT01078454November 201027/2/2010Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain AmyloidosisA Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-Chain (AL) Amyloidosis Ineligible for Autologous Stem-Cell TransplantationLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: melphalan;Drug: dexamethasone;Drug: bortezomibNational Cancer Institute (NCI)NULLCompleted18 YearsN/AAll11Phase 3United States
144EUCTR2010-022395-31-IT07/10/201001/12/2010A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - NDA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - ND AL amyloidosis
MedDRA version: 9.1Level: HLGTClassification code 10035227
Trade Name: VELCADE
INN or Proposed INN: Bortezomib
INN or Proposed INN: Melphalan
INN or Proposed INN: Dexamethasone
INN or Proposed INN: Melphalan
INN or Proposed INN: Dexamethasone
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
145NCT01194791October 201026/7/2010Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly DiagnosedA Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell TransplantationPrimary Systemic AmyloidosisDrug: Lenalidomide;Drug: Cyclophosphamide;Drug: DexamethasonePETHEMA FoundationNULLCompleted18 YearsN/AAll30Phase 2Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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size
PhaseCountries
146EUCTR2009-014906-33-GB17/09/201018/06/2010A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEALA Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL Systemic AL amyloidosis
MedDRA version: 14.1Level: PTClassification code 10002022Term: AmyloidosisSystem Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
Product Name: bortezomib
INN or Proposed INN: bortezomib
Trade Name: Velcade
Product Name: bortezomib
INN or Proposed INN: bortezomib
University College LondonNULLNot RecruitingFemale: yes
Male: yes
52United Kingdom
147EUCTR2006-001066-16-GB25/08/201018/06/2010A randomized, double-blind, placebo-controlled, international multi-center trial ofdiflunisal on neurologic disease progression in 200 familial amyloid subjects - The effect of diflunisal on familial amyloidosisA randomized, double-blind, placebo-controlled, international multi-center trial ofdiflunisal on neurologic disease progression in 200 familial amyloid subjects - The effect of diflunisal on familial amyloidosis Hereditary neuropathic amyloidosis
MedDRA version: 11.Level: LLTClassification code 10019889Term: Hereditary neuropathic amyloidosis
Trade Name: Dolobid
Product Name: diflunisal (dolobid)
INN or Proposed INN: diflunisal
Other descriptive name: 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid
John L. BerkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140United Kingdom;Italy;Sweden
148NCT01072773March 201017/2/2010Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain AmyloidosisPhase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain AmyloidosisPrimary Systemic AmyloidosisDrug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasoneMayo ClinicNULLCompleted18 YearsN/AAll2Phase 2United States
149EUCTR2009-011535-12-IT14/01/201025/11/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - NDOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - ND Patients with Transthyretin Amyloidosis
MedDRA version: 12.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
FOLDRX PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;Germany;France;Italy;Sweden
150EUCTR2009-011535-12-PT09/09/200915/07/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin AmyloidosisOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 14.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
INN or Proposed INN: tafamidis
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-,2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
110France;United States;Portugal;Argentina;Brazil;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT01083316September 20092/11/2009Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) AmyloidosisPhase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: Dexamethasone;Drug: MelphalanBoston Medical CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll35Phase 2United States
152EUCTR2009-011535-12-DE26/08/200918/05/2009In preparationOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 14.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
INN or Proposed INN: tafamidis
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Pfizer Inc.NULLNot RecruitingFemale: yes
Male: yes
110Portugal;Germany;Argentina;France;Italy;United States;Sweden;Brazil
153NCT00890747August 200929/4/2009Sunitinib Malate in Treating HIV-Positive Patients With Cancer Receiving Antiretroviral TherapyA Phase 1/Pharmacokinetic Study of Sunitinib in Patients With Cancer Who Also Have HIV and Are on HAART TherapyAccelerated Phase Chronic Myelogenous Leukemia;Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Langerhans Cell Histiocytosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aggressive NK-cell Leukemia;AIDS-related Diffuse Large Cell Lymphoma;AIDS-related Diffuse Mixed Cell Lymphoma;AIDS-related Diffuse Small Cleaved Cell Lymphoma;AIDS-related Immunoblastic Large Cell Lymphoma;AIDS-related Lymphoblastic Lymphoma;AIDS-related Malignancies;AIDS-related Small Noncleaved Cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Clear Cell Renal Cell Carcinoma;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;HIV Infection;HIV-associated Hodgkin Lymphoma;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Mast Cell Leukemia;Myelodysplastic Syndrome With Isolated Del(5q);Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Osteolytic Lesions of Multiple Myeloma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Renal Cell Cancer;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Stage IV Renal Cell Cancer;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: sunitinib malate;Other: pharmacological study;Other: laboratory biomarker analysisNational Cancer Institute (NCI)NULLCompleted18 YearsN/ABoth42Phase 1United States
154EUCTR2009-011535-12-FR31/07/200919/06/2009Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin AmyloidosisOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylat
FoldRx Pharmaceuticals, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;Germany;France;Italy;Sweden
155EUCTR2009-011535-12-SE24/06/200910/06/2009To obtain additional long-term, safety and efficacy data for tafamidis in subjects with transthyretin (TTR) familial amyloid polyneuropathy (TTR-FAP) and to continue to provide the Tafamidis to subjects with TTR-FAP who have completed Protocol Fx-006 or Protocol Fx1A-201Open-Label Safety and Efficacy Evaluation of Fx-1006A in Subjects with Transthyretin (TTR) Amyloidosis Transthyretin Amyloidosis (ATTR)
MedDRA version: 16.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Clinical trial image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Trade Name: Vyndaqel 20mg soft capsule
Product Name: Tafamidis Meglumine 20mg Soft Gelatin Capsule (Commerical image)
Product Code: PF-06291826-83/Fx-1006A
INN or Proposed INN: Tafamidis meglumine
Other descriptive name: tafamidis meglumine 20 mg soft gelatin capsules
Pfizer Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Portugal;France;United States;Argentina;Brazil;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156JPRN-UMIN0000018252009/04/0131/03/2009Treatment of familial amyloid polyneuropathy (FAP) using diflunisal familial amyloid polyneuropathy (FAP)Orally administration of diflunisalShinshu UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
157NCT00883623April 200915/4/2009A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) AmyloidosisA Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL AmyloidosisPrimary AmyloidosisDrug: LenalidomideHeidelberg UniversityGesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbHCompleted18 Years74 YearsBoth50Phase 2Germany
158NCT00890552April 200928/4/2009A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisA Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisLeukemia;AmyloidosisDrug: Lenalidomide;Drug: Melphalan;Drug: DexamethasoneStanford UniversityCelgene CorporationCompleted18 YearsN/AAll25N/AUnited States
159EUCTR2008-001262-87-DE16/03/200929/01/2009An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
160NCT01815086December 200813/3/2013Radioimmunoimaging of Light Chain (AL) AmyloidosisRadioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody (mAb) Murine (Mu) 11-F4AL AmyloidosisBiological: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)University of TennesseeNULLCompleted21 Years90 YearsBoth30Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT00807872December 200811/12/2008Radioimmunoimaging of AL AmyloidosisRadioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4Primary AmyloidosisBiological: 124I-labeled monoclonal antibody Mu 11-1F4University of TennesseeFDA Office of Orphan Products DevelopmentCompleted21 Years90 YearsBoth40Phase 1United States
162NCT01409148November 200828/7/2011Radioimmunoimaging of AL AmyloidosisRadioimmunoimaging (PET/CT) of Patients With AL Amyloidosis Using the 124I-Labeled Amyloid-Reactive Monoclonal Antibody Mu 11-1F4AL AmyloidosisBiological: 124I-labeled monoclonal antibody Mu 11-1F4University of TennesseeFood and Drug Administration (FDA)Completed21 Years90 YearsBoth38Phase 1United States
163EUCTR2008-001405-41-DE24/10/200828/08/2008A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEXA prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX AL amyloidosisTrade Name: Revlimid
Other descriptive name: Lenalidomide
Trade Name: Alkeran
Product Code: L01AA03
Other descriptive name: melphalan
Trade Name: Fortecortin
Other descriptive name: dexamethasone
GMIHO mbHNULLNot RecruitingFemale: yes
Male: yes
Germany
164EUCTR2007-006791-12-IT15/09/200824/07/2008The Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - NDThe Effects of Fx-1006A on Transthyretin Stabilization and Clinical Outcome Measures in Patients with Non-V30M Transthyretin Amyloidosis - ND Patients with Non-V30M Transthyretin Amyloidosis
MedDRA version: 9.1Level: LLTClassification code 10016202Term: Familial amyloidosis
Product Code: Fx-1006AFOLDRX PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
16Germany;France;Italy
165EUCTR2008-001262-87-PT04/07/200821/04/2008An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2008-001262-87-FR04/07/200830/05/2008An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
167NCT00791492July 200813/11/2008An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid PolyneuropathyAn Open-Label Extension Of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid PolyneuropathyFamilial Amyloid Polyneuropathy;ATTR-PNDrug: Fx-1006APfizerNULLCompleted18 Years75 YearsAll86Phase 2/Phase 3Argentina;Brazil;France;Germany;Portugal;Sweden
168EUCTR2008-001262-87-SE23/06/200826/05/2008An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicable Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
169NCT00790647June 200812/11/2008Melphalan, Bortezomib, and Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase II Trial of High-dose Melphalan and Bortezomib and Stem Cell Transplantation in Patients With AL AmyloidosisMultiple MyelomaBiological: filgrastim;Drug: bortezomib;Drug: melphalan;Procedure: Stem Cell InfusionBoston Medical CenterNULLCompleted18 Years65 YearsAll10Phase 2United States
170NCT00679367May 200814/5/2008Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomide;Drug: melphalanBoston Medical CenterNULLCompleted18 YearsN/AAll16Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2007-006037-13-IT21/02/200810/12/2007An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - NDAn open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND amyloidosis AL
MedDRA version: 6.1Level: PTClassification code 10002022
Trade Name: Revlimid
INN or Proposed INN: Cyclophosphamide
INN or Proposed INN: Dexamethasone
OSPEDALE POLICLINICO S. MATTEONULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
172NCT00981708February 200819/9/2009Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic AmyloidosisAmyloidosisDrug: Lenalidomide, Dexamethasone and CyclophosphamideUniversity of AthensHellenic Cooperative Oncology GroupActive, not recruiting18 YearsN/ABoth37Phase 1/Phase 2Greece
173NCT00607581February 200822/1/2008Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAn Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAmyloidosisDrug: cyclophosphamide;Drug: lenalidomide;Drug: dexamethasoneIRCCS Policlinico S. MatteoCelgene CorporationCompleted18 YearsN/ABoth21Phase 2Italy
174NCT00564889December 200728/11/2007Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: cyclophosphamide;Drug: dexamethasone;Drug: lenalidomideMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll35Phase 2United States
175NCT01998503December 200715/11/2013Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL AmyloidosisInduction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: dexamethasone;Biological: filgrastim;Procedure: autologous hematopoietic stem cell transplantation (ASCT);Drug: MelphalanNanjing University School of MedicineNULLCompleted18 Years65 YearsBoth56Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2006-007082-36-GR16/10/200718/07/2007A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosisA Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatmentsTrade Name: REVLIMID
Trade Name: Endoxan
Trade Name: Dexamethasone
Trade Name: REVLIMID
INN or Proposed INN: Lenalidomide
INN or Proposed INN: Deaxamethasone
INN or Proposed INN: cyclophosphamide
Hellenic Oncology Cooperative GroupNULLNot RecruitingFemale: yes
Male: yes
55Phase 1/2Greece
177EUCTR2006-002792-41-DE08/10/200720/06/2007Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): A Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study - Not applicableSafety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): A Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study - Not applicable Familial Amyloid Polyneuropathy (FAP)
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2/3Portugal;United Kingdom;Germany;Spain;Sweden
178EUCTR2006-006395-37-GB06/09/200731/07/2007A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT)A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) The medical condition to be investigated is systemic AL Amyloidosis, a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function.
MedDRA version: 9.1 Level: LLT Classification code 10002022 Term: Amyloidosis
Joint UCLH and UCL Biomedical Research UnitNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited Kingdom
179NCT00520767September 200724/8/2007Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition DiseaseA Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition DiseasePrimary Systemic Amyloidosis;Light Chain Deposition DiseaseDrug: bortezomib;Drug: dexamethasone;Drug: melphalan;Genetic: microarray analysis;Other: flow cytometry;Other: laboratory biomarker analysis;Procedure: quality-of-life assessmentBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 Years120 YearsAll35Phase 2United States
180EUCTR2006-002792-41-GB06/07/200729/09/2006Safety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled StudySafety and efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study Familial Amyloid Polyneuropathy (FAP).Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylat
FoldRx Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2;Phase 3Portugal;Spain;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00458822February 20079/4/2007Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic AmyloidosisRisk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: bortezomib;Drug: dexamethasoneMemorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed18 Years70 YearsAll40Phase 2United States
182EUCTR2006-001066-16-IT30/01/200709/03/2007The effect of diflunisal IND 68092 on familial amyloidosis a randomized, double-blind, placebo-controlled, international multi-center trial of diflunisal on neurologic disease progression in 200 familial amyloid subjects. - NDThe effect of diflunisal IND 68092 on familial amyloidosis a randomized, double-blind, placebo-controlled, international multi-center trial of diflunisal on neurologic disease progression in 200 familial amyloid subjects. - ND familial amyloidosis
MedDRA version: 9.1Level: LLTClassification code 10016202Term: Familial amyloidosis
Trade Name: Dolobid Boston University- The Amyloid Treatment and Research ProgramNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200United Kingdom;Italy;Sweden
183EUCTR2006-001066-16-SE04/01/200709/11/2006The effect of diflunisal (IND 68092) on familial amyloidosis - The Diflunisal TrialThe effect of diflunisal (IND 68092) on familial amyloidosis - The Diflunisal Trial Familial Amyloid Polyneuropathy (FAP)Trade Name: Dolobid
Product Name: diflunisal (dolobid)
INN or Proposed INN: diflunisal
Other descriptive name: 2',4'-difluoro-4-hydroxy-3-biphenylcarboxylic acid
John L. Berk, M.D.NULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Italy;Sweden
184NCT00409175January 20076/12/2006Safety and Efficacy Study of Fx-1006A in Patients With Familial AmyloidosisSafety and Efficacy of Orally Administered Fx-1006A in Patients With Familial Amyloid Polyneuropathy (FAP): A Randomized, Double-blind, Placebo-controlled StudyFamilial Amyloid PolyneuropathyDrug: Fx-1006A;Drug: PlaceboPfizerNULLCompleted18 Years75 YearsAll128Phase 2/Phase 3United States;Argentina;Brazil;France;Germany;Portugal;Spain;Sweden;United Kingdom
185EUCTR2006-002792-41-PT23/11/200614/09/2006Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled StudySafety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study Familial Amyloid Polyneuropathy (FAP).Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2/3Portugal;Germany;United Kingdom;Spain;Sweden
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186EUCTR2006-002792-41-SE30/10/200601/09/2006Safety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled StudySafety and Efficacy of Orally Administered Fx-1006A in Patients with Familial Amyloid Polyneuropathy (FAP): a Phase II/III, Randomised, Double-Blind, Placebo-Controlled Study Familial Amyloid Polyneuropathy (FAP).
MedDRA version: 9.1Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathy
Product Code: Fx-1006A
Other descriptive name: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium;2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate
FoldRx Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2/3Portugal;Germany;United Kingdom;Spain;Sweden
187EUCTR2006-001927-20-IT01/07/200615/06/2007Treatment with Anakinra in TRAPS - NDTreatment with Anakinra in TRAPS - ND TRAPS
MedDRA version: 9.1Level: LLTClassification code 10016202Term: Familial amyloidosis
Trade Name: KINERET*SC 7SIR 100MG 0,67ML
INN or Proposed INN: Anakinra
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Italy
188NCT00536601June 29, 200627/9/2007High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid TumorsAutologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid TumorsAdult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET);Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Nodal Marginal Zone B-cell Lymphoma;Peripheral T-cell Lymphoma;Plasma Cell Neoplasm;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Malignant Testicular Germ Cell Tumor;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Neuroblastoma;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Multiple Myeloma;Regional Neuroblastoma;Splenic Marginal Zone Lymphoma;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: etoposide;Drug: cyclophosphamide;Drug: carmustine;Drug: melphalan;Drug: busulfan;Drug: carboplatin;Drug: thiotepa;Radiation: total-body irradiation;Procedure: autologous hematopoietic stem cell transplantation;Procedure: autologous-autologous tandem hematopoietic stem cell transplantationRoswell Park Cancer InstituteNational Cancer Institute (NCI)Completed4 YearsN/AAll174N/AUnited States
189NCT00294671February 200621/2/2006The Effect of Diflunisal on Familial AmyloidosisThe Effect of Diflunisal on Familial AmyloidosisFamilial Amyloid Polyneuropathy;Familial AmyloidosisDrug: diflunisal;Other: placeboBoston UniversityFood and Drug Administration (FDA);National Institute of Neurological Disorders and Stroke (NINDS)Completed18 Years75 YearsAll130Phase 2/Phase 3United States;Italy;Japan;Sweden;United Kingdom;Portugal
190NCT00477971October 200523/5/2007Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL)Multiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantationMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll89Phase 3United States
No.TrialIDDate_
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191EUCTR2004-004871-12-IT02/05/200507/06/2005An Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-AmyloidosisAn Open-Label Phase 1/2 Study of VELCADE (bortezomib) for Injection in Subjects with Light-Chain (AL)-Amyloidosis Systemic AL-Amyloidosis
MedDRA version: 6.1Level: PTClassification code 10002022
Trade Name: VELCADE*1FL 3,5MG
Product Name: NA
Product Code: NA
INN or Proposed INN: Bortezomib
JANSSEN-CILAGNULLNot RecruitingFemale: yes
Male: yes
Phase 1/2Italy
192NCT00166413April 200512/9/2005Efficacy of CC-5013 (Revlimid or Lenalidomide) in Patients With Primary Systemic AmyloidosisA Phase II Trial of CC-5013 in Patients With Primary Systemic AmyloidosisAmyloidosisDrug: CC-5013Mayo ClinicNULLCompleted18 YearsN/ABoth38Phase 2United States
193NCT00064337January 20048/7/2003S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic AmyloidosisS0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)Multiple Myeloma;Plasma Cell MyelomaBiological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantationSouthwest Oncology GroupNational Cancer Institute (NCI)Completed18 Years120 YearsAll104Phase 2United States
194NCT00091260January 20047/9/2004CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomideVaishali SanchorawalaCelgene CorporationCompleted18 YearsN/AAll82Phase 2United States
195NCT00052884October 200324/1/2003Amifostine and Melphalan in Treating Patients With Primary Systemic Amyloidosis Who Are Undergoing Peripheral Stem Cell TransplantationA Phase I Study of Amifostine Followed by High-Dose Escalation of Melphalan With Stem Cell Reconstitution for Patients With Primary Systemic AmyloidosisDrug/Agent Toxicity by Tissue/Organ;Multiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: amifostine trihydrate;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationEastern Cooperative Oncology GroupNational Cancer Institute (NCI)Terminated18 Years70 YearsBoth8Phase 1United States
No.TrialIDDate_
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196NCT01527032September 200228/7/2011Risk-adapted Therapy for Primary Systemic (AL) AmyloidosisRisk-adapted Therapy for AL AmyloidosisAmyloidosisDrug: melphalan, thalidomide and dexamethasoneFDA Office of Orphan Products DevelopmentNULLCompletedPhase 2NULL
197NCT00089167May 20024/8/2004Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic AmyloidosisRisk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Drug: thalidomideMemorial Sloan Kettering Cancer Center.National Cancer Institute (NCI)Completed18 YearsN/ABothPhase 2United States
198NCT00030381December 200114/2/2002Iododoxorubicin in Treating Patients With Primary Systemic AmyloidosisPhase I Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)Primary Systemic AmyloidosisDrug: 4'-iodo-4'-deoxydoxorubicin;Other: pharmacological studyNational Cancer Institute (NCI)NULLTerminated18 YearsN/ABoth22Phase 1United States
199NCT00075608August 20019/1/20042nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) AmyloidosisPhase II Trial of Second Autologous Transplantation in AL AmyloidosisMultiple Myeloma;Plasma Cell NeoplasmBiological: filgrastim;Drug: melphalan;Procedure: autologous stem cell transplantation;Procedure: stem cell infusionBoston Medical CenterNULLTerminated18 Years65 YearsAll12Phase 2United States
200NCT00025415August 200111/10/2001Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver DysfunctionA Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver DysfunctionAccelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;AIDS-related Peripheral/Systemic Lymphoma;AIDS-related Primary CNS Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Blastic Phase Chronic Myelogenous Leukemia;Childhood Myelodysplastic Syndromes;Chronic Eosinophilic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Gastrointestinal Stromal Tumor;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Meningeal Chronic Myelogenous Leukemia;Monoclonal Gammopathy of Undetermined Significance;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Polycythemia Vera;Previously Treated Myelodysplastic Syndromes;Primary Central Nervous System Non-Hodgkin Lymphoma;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Unspecified Adult Solid Tumor, Protocol Specific;Untreated Adult Acute Lymphoblastic Leukemia;Untreated Adult Acute Myeloid Leukemia;Untreated Hairy Cell Leukemia;Waldenström MacroglobulinemiaDrug: imatinib mesylate;Other: pharmacological studyNational Cancer Institute (NCI)NULLCompleted15 YearsN/ABoth60Phase 1United States
No.TrialIDDate_
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201NCT00224393February 200121/9/2005Phase II Trial of Enbrel in Patients With Primary Systemic AmyloidosisPrimary Systemic AmyloidosisDrug: EnbrelThe Cleveland ClinicNULLSuspended18 YearsN/ABoth60Phase 2NULL
202NCT00014235December 200010/4/2001Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic MalignanciesNonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based ImmunosuppressionAcute Myeloid Leukemia/Transient Myeloproliferative Disorder;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Blastic Plasmacytoid Dendritic Cell Neoplasm;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Multiple Myeloma;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Untreated Adult Acute Lymphoblastic Leukemia;Untreated Adult Acute Myeloid Leukemia;Untreated Childhood Acute Lymphoblastic Leukemia;Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies;Waldenström MacroglobulinemiaDrug: fludarabine phosphate;Radiation: total-body irradiation;Procedure: peripheral blood stem cell transplantation;Procedure: allogeneic hematopoietic stem cell transplantation;Drug: cyclosporine;Drug: mycophenolate mofetil;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI)CompletedN/A74 YearsAll160N/AUnited States;Germany;Italy
203NCT00075621August 20009/1/2004Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) AmyloidosisA Phase II Trial of Tandem Transplantation in AL AmyloidosisMultiple MyelomaDrug: filgrastim;Drug: melphalan;Procedure: autologous peripheral blood stem cell transplantationBoston Medical CenterNULLCompleted18 Years65 YearsAll62Phase 2United States
204NCT00006251May 200011/9/2000Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine, Mycophenolate Mofetil, Donor Lymphocyte Infusion in Treating Patients With Hematopoietic CancerInduction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate MofetilAcute Undifferentiated Leukemia;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Childhood Burkitt Lymphoma;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Cutaneous B-cell Non-Hodgkin Lymphoma;de Novo Myelodysplastic Syndromes;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Intraocular Lymphoma;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Systemic Amyloidosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Renal Cell Cancer;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage II Multiple Myeloma;Stage III Multiple Myeloma;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Waldenström MacroglobulinemiaRadiation: total-body irradiation;Drug: fludarabine phosphate;Drug: cyclosporine;Drug: mycophenolate mofetil;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Biological: donor lymphocytes;Procedure: peripheral blood stem cell transplantation;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)CompletedN/A74 YearsAll21Phase 1/Phase 2United States;Italy;Germany
205NCT00344526January 200022/6/2006Intensive Versus Conventional Treatment in Patients With Primary AmyloidosisAutologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .Primary Systemic Amyloidosis (AL)Drug: Melphalan;Drug: Dexamethasone;Procedure: Autologous stem cell transplantationUniversity Hospital, LimogesMinistry of Health, FranceCompleted18 Years70 YearsBoth100Phase 3France
No.TrialIDDate_
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206NCT00112593November 19992/6/2005Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without CancerAllogeneic Hematopoietic Stem Cell Transplantation for Induction of Mixed Hematopoietic Chimerism in Patients Infected With Human Immunodeficiency Virus-1 Using a Non-Marrow Ablative Conditioning Regimen Containing Total Body Irradiation in Combination With Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate MofetilAccelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aggressive NK-cell Leukemia;AIDS-related Diffuse Large Cell Lymphoma;AIDS-related Diffuse Mixed Cell Lymphoma;AIDS-related Diffuse Small Cleaved Cell Lymphoma;AIDS-related Immunoblastic Large Cell Lymphoma;AIDS-related Lymphoblastic Lymphoma;AIDS-related Peripheral/Systemic Lymphoma;AIDS-related Primary CNS Lymphoma;AIDS-related Small Noncleaved Cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Blastic Phase Chronic Myelogenous Leukemia;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Burkitt Lymphoma;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Contiguous Stage II Adult Burkitt Lymphoma;Contiguous Stage II Adult Diffuse Large Cell Lymphoma;Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Contiguous Stage II Adult Lymphoblastic Lymphoma;Contiguous Stage II Grade 1 Follicular Lymphoma;Contiguous Stage II Grade 2 Follicular Lymphoma;Contiguous Stage II Grade 3 Follicular Lymphoma;Contiguous Stage II Mantle Cell Lymphoma;Contiguous Stage II Marginal Zone Lymphoma;Contiguous Stage II Small Lymphocytic Lymphoma;Cutaneous B-cell Non-Hodgkin Lymphoma;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;HIV Infection;HIV-associated Hodgkin Lymphoma;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Juvenile Myelomonocytic Leukemia;Mast Cell Leukemia;Meningeal Chronic Myelogenous Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Myeloid/NK-cell Acute Leukemia;Nodal Marginal Zone B-cell Lymphoma;Noncontiguous Stage II Adult Burkitt Lymphoma;Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma;Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma;Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma;Noncontiguous Stage II Adult Lymphoblastic Lymphoma;Noncontiguous Stage II Grade 1 Follicular Lymphoma;Noncontiguous Stage II Grade 2 Follicular Lymphoma;Noncontiguous Stage II Grade 3 Follicular Lymphoma;Noncontiguous Stage II Mantle Cell Lymphoma;Noncontiguous Stage II Marginal Zone Lymphoma;Noncontiguous Stage II Small Lymphocytic Lymphoma;Noncutaneous Extranodal Lymphoma;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Central Nervous System Lymphoma;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage 0 Chronic Lymphocytic Leukemia;Stage I Adult Burkitt Lymphoma;Stage I Adult Diffuse Large Cell Lymphoma;Stage I Adult Diffuse Mixed Cell Lymphoma;Stage I Adult Diffuse Small Cleaved Cell Lymphoma;Stage I Adult Hodgkin Lymphoma;Stage I Adult Immunoblastic Large Cell Lymphoma;Stage I Adult Lymphoblastic Lymphoma;Stage I Adult T-cell Leukemia/Lymphoma;Stage I Childhood Anaplastic Large Cell Lymphoma;Stage I Childhood Hodgkin Lymphoma;Stage I Childhood Large Cell Lymphoma;Stage I Childhood Lymphoblastic Lymphoma;Stage I Childhood Small Noncleaved Cell Lymphoma;Stage I Chronic Lymphocytic Leukemia;Stage I Cutaneous T-cell Non-Hodgkin Lymphoma;Stage I Grade 1 Follicular Lymphoma;Stage I Grade 2 Follicular Lymphoma;Stage I Grade 3 Follicular Lymphoma;Stage I Mantle Cell Lymphoma;Stage I Marginal Zone Lymphoma;Stage I Multiple Myeloma;Stage I Small Lymphocytic Lymphoma;Stage IA Mycosis Fungoides/Sezary Syndrome;Stage IB Mycosis Fungoides/Sezary Syndrome;Stage II Adult Hodgkin Lymphoma;Stage II Adult T-cell Leukemia/Lymphoma;Stage II Childhood Anaplastic Large Cell Lymphoma;Stage II Childhood Hodgkin Lymphoma;Stage II Childhood Large Cell Lymphoma;Stage II Childhood Lymphoblastic Lymphoma;Stage II Childhood Small Noncleaved Cell Lymphoma;Stage II Chronic Lymphocytic Leukemia;Stage II Cutaneous T-cell Non-Hodgkin Lymphoma;Stage II Multiple Myeloma;Stage IIA Mycosis Fungoides/Sezary Syndrome;Stage IIB Mycosis Fungoides/Sezary Syndrome;Stage III Adult Burkitt Lymphoma;Stage III Adult Diffuse Large Cell Lymphoma;Stage III Adult Diffuse Mixed Cell Lymphoma;Stage III Adult Diffuse Small Cleaved Cell Lymphoma;Stage III Adult Hodgkin Lymphoma;Stage III Adult Immunoblastic Large Cell Lymphoma;Stage III Adult Lymphoblastic Lymphoma;Stage III Adult T-cell Leukemia/Lymphoma;Stage III Childhood Anaplastic Large Cell Lymphoma;Stage III Childhood Hodgkin Lymphoma;Stage III Childhood Large Cell Lymphoma;Stage III Childhood Lymphoblastic Lymphoma;Stage III Childhood Small Noncleaved Cell Lymphoma;Stage III Chronic Lymphocytic Leukemia;Stage III Cutaneous T-cell Non-Hodgkin Lymphoma;Stage III Grade 1 Follicular Lymphoma;Stage III Grade 2 Follicular Lymphoma;Stage III Grade 3 Follicular Lymphoma;Stage III Mantle Cell Lymphoma;Stage III Marginal Zone Lymphoma;Stage III Multiple Myeloma;Stage III Small Lymphocytic Lymphoma;Stage IIIA Mycosis Fungoides/Sezary Syndrome;Stage IIIB Mycosis Fungoides/Sezary Syndrome;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Childhood Anaplastic Large Cell Lymphoma;Stage IV Childhood Hodgkin Lymphoma;Stage IV Childhood Large Cell Lymphoma;Stage IV Childhood Lymphoblastic Lymphoma;Stage IV Childhood Small Noncleaved Cell Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Small Lymphocytic Lymphoma;Stage IVA Mycosis Fungoides/Sezary Syndrome;Stage IVB Mycosis Fungoides/Sezary Syndrome;T-cell Large Granular Lymphocyte Leukemia;Testicular Lymphoma;Unspecified Adult Solid Tumor, Protocol Specific;Unspecified Childhood Solid Tumor, Protocol Specific;Waldenström MacroglobulinemiaDrug: fludarabine phosphate;Radiation: total-body irradiation;Procedure: peripheral blood stem cell transplantation;Drug: cyclosporine;Drug: mycophenolate mofetil;Other: laboratory biomarker analysisFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)CompletedN/A75 YearsAll5N/AUnited States
207NCT00007995July 19996/1/2001Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic AmyloidosisPhase 2 Study Of High Dose Chemotherapy Followed By Autologous Hematopoietic Stem Cell Support In Patients With Multiple Myeloma And Primary Light Chain AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Biological: recombinant interferon alfa;Biological: sargramostim;Drug: busulfan;Drug: cyclophosphamide;Drug: melphalan;Procedure: autologous bone marrow transplantation;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationHerbert Irving Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed18 YearsN/ABoth75Phase 2United States
208NCT00003853April 19991/11/19994'-Iodo-4'-Deoxydoxorubicin in Treating Patients With Primary Systemic AmyloidosisPhase II Trial of 4'-IODO-4'-Deoxydoxorubicin in Primary Amyloidosis (AL)Multiple Myeloma and Plasma Cell NeoplasmDrug: 4'-iodo-4'-deoxydoxorubicinNational Cancer Institute (NCI)NULLCompleted18 YearsN/ABoth45Phase 2United States;Italy
209NCT00003353July 19981/11/1999High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic AmyloidosisA Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: melphalan;Procedure: bone marrow ablation with stem cell support;Procedure: peripheral blood stem cell transplantationEastern Cooperative Oncology GroupNational Cancer Institute (NCI)Completed18 Years70 YearsBothPhase 2United States
210NCT00002849November 19961/11/1999S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic AmyloidosisPhase II Study of Dexamethasone/Alpha-Interferon in AL AmyloidosisMultiple MyelomaBiological: recombinant interferon alfa;Drug: dexamethasoneSouthwest Oncology GroupNational Cancer Institute (NCI);Cancer and Leukemia Group BCompleted18 YearsN/ABoth93Phase 2United States
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211EUCTR2017-005115-13-FR27/02/2018A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3A Non-Interventional Study to Monitor the Survival Status ofPatients that Discontinued from ISIS 420915-CS2 orISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 20.0Level: LLTClassification code 10057949Term: Familial amyloid polyneuropathySystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
INN or Proposed INN: ISIS 420915
Other descriptive name: Inotersen
Ionis Pharmaceuticals, Inc.NULLNAFemale: yes
Male: yes
164Phase 3Portugal;United States;France;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
212EUCTR2017-005115-13-GB06/03/2018 A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3 A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3 Familial Amyloid Polyneuropathy
MedDRA version: 20.0 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Ionis Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
164 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;France;United States;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom