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 28. 全身性アミロイドーシス [臨床試験数:111,薬物数:123(DrugBank:62),標的遺伝子数:50,標的パスウェイ数:161] 

Searched query = "Systemic amyloidosis", "AL amyloidosis", "Immunoglobulin light chain amyloidosis", "Amyloid light-chain amyloidosis", "Familial amyloid polyneuropathy", "Senile systemic amylodosis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04115956November 201922 October 2019A Clinical Study of 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: Melflufen;Drug: DexamethasoneOncopeptides ABPRA Health SciencesNot recruiting18 YearsN/AAll46Phase 1/Phase 2United States;Czechia;France;Germany;Greece;Israel;Italy;Norway;Poland;Spain;United Kingdom
2NCT03474458February 11, 201916 September 2019A 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. MatteoRecruiting18 YearsN/AAll120Phase 2/Phase 3Canada;France;Germany;Greece;Italy;Spain;Turkey;United Kingdom
3NCT03678259October 1, 20189 October 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 MedicineRecruiting18 YearsN/AAll43Phase 1United States
4NCT03618537August 2, 201815 July 2019Ixazomib 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
5EUCTR2017-005115-13-ES25/04/201811 June 2018A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3Familial 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]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ISIS 420915
CAS Number: 1432726-13-0
Current Sponsor code: ISIS 420915
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Ionis Pharmaceuticals, Inc.AuthorisedFemale: yes
Male: yes
164Phase 3United Kingdom;New Zealand;Italy;Portugal;France;United States;Argentina;Brazil;Spain;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-001737-27-NL15/03/201828 February 2019A 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 AmyloidosisAL 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]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DARATUMUMAB
CAS Number: 945721-28-8
Current Sponsor code: JnJ 54767414
Other descriptive name: HUMAX-CD38
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 120-
Janssen-Cilag International N.V.Authorised Female: yes
Male: yes
370Phase 3United 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
7NCT03130348March 15, 201812 March 2018Ibrutinib 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)Not recruiting18 YearsN/AAll0Phase 2United States
8NCT03499808March 8, 201815 July 2019S1702 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)Recruiting18 YearsN/AAll39Phase 2United States
9NCT03283917February 7, 20182 September 2019Daratumumab, 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
10NCT02994784January 8, 201821 January 2019Propylene 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 HydrochlorideShayna SarosiekSpectrum Pharmaceuticals, IncRecruiting18 YearsN/AAll43Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
11NCT03315026December 14, 201714 October 2019Siltuximab 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, LLCRecruiting60 Years75 YearsAll30Phase 2United States
12NCT03201965October 5, 201730 September 2019A 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, LLCNot recruiting18 YearsN/AAll417Phase 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
13ChiCTR-IPR-170126372017-10-012 October 2017Prospective 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 amyloidosistype AL amyloidosisGroup 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);Guangdong General HospitalNot Recruiting1875BothGroup 1:35;Group 2:35;Post-marketChina
14NCT03252600August 25, 201725 February 2019Lenalidomide, 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
15EUCTR2016-004664-18-ES31/07/201723 July 2018A 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: 20.0 Level: PT Classification code 10036673 Term: Primary amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: NEOD001
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Prothena Therapeutics LimitedNot RecruitingFemale: yes
Male: yes
100Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03154047June 14, 201718 June 2018Study 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.Not recruiting18 YearsN/AAll80Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
17NCT03236792June 12, 201721 January 2019Ixazomib 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
18NCT02841033March 20, 201730 September 2019Daratumumab for the Treatment of Patients With AL AmyloidosisA Phase I-II Trial of Daratumumab for the Treatment of Patients With AL AmyloidosisAL AmyloidosisDrug: daratumumabVaishali SanchorawalaJanssen PharmaceuticalsNot recruiting18 YearsN/AAll25Phase 1/Phase 2United States
19NCT03000660January 201713 May 2019Trial 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 CenterNot recruiting18 YearsN/AAll25Phase 1United States
20EUCTR2017-005115-13-FR20 August 2018A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3A Non-Interventional Study to Monitor the Survival Status of Patients that Discontinued from ISIS 420915-CS2 or ISIS 420915-CS3Familial 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]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ISIS 420915
CAS Number: 1432726-13-0
Current Sponsor code: ISIS 420915
Other descriptive name: Inotersen
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Ionis Pharmaceuticals, Inc.Not AvailableFemale: yes
Male: yes
164Phase 3Portugal;United States;France;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
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size
PhaseCountries
21EUCTR2016-000276-23-GB06/12/201619 March 2018Study to look at the affect of anti-SAP treatment in patients with cardiac amyloidosisA multiple treatment session, open label phase 2 clinical study of GSK2398852 administered following and together with GSK2315698 in cohorts of patients with cardiac amyloidosisSystemic 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]
Product Name: GSK2315698
Product Code: GSK2315698
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: miridesap
CAS Number: 224624-80-A
Current Sponsor code: GSK2315698
Other descriptive name: CPHC (carboxy pyrrolidine hexanoyl pyrrolidone carboxylate)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Product Name: GSK2398852
Product Code: GSK2398852
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: dezamizumab
Current Sponsor code: GSK2398852
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
GlaxoSmithKline Research & Development LtdAuthorisedFemale: yes
Male: yes
30Phase 2United States;United Kingdom
22NCT02816476September 201615 July 2019Daratumumab 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, LimogesNot recruiting18 YearsN/AAll40Phase 2France;Italy
23EUCTR2015-004318-14-DE13/06/201628 May 2018A 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 DysfunctionLight 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: 20.0 Level: PT Classification code 10036673 Term: Primary amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: NEOD001
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: NEOD001
Other descriptive name: Humanized IgG1, kappa anti-serum amyloid A and anti-AL amyloid antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous drip use (Noncurrent)
Prothena Therapeutics LimitedNot RecruitingFemale: yes
Male: yes
129Phase 2France;United States;Greece;Spain;Austria;Australia;Israel;Germany;Italy;United Kingdom
24EUCTR2016-000287-42-FR18/05/20164 July 2016Amyloidosis Patients traitmentA Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis Patients not in VGPR or Better - AMYDARAAL Amyloidosis
MedDRA version: 19.0 Level: HLGT Classification code 10035227 Term: Plasma cell neoplasms System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Body processes [G] - Biological Phenomena [G16]
Product Name: HuMax-CD38
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DARATUMUMAB
CAS Number: 945721-28-8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
CHU de LimogesAuthorisedFemale: yes
Male: yes
40Phase 2France
25NCT02603172May 12, 201620 August 2018A 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: GSK3039294GlaxoSmithKlineNot recruiting18 Years70 YearsAll18Phase 1United Kingdom
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
26ChiCTR-IPR-160084222016-05-0518 April 2017Randomized 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 UniversityRecruiting1875Boththe first group:60;the second group:60;Post-marketChina
27NCT02632786March 201615 April 2019The 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.Not recruiting18 YearsN/AAll129Phase 2United States;Australia;Austria;France;Germany;Greece;Israel;Italy;Spain;United Kingdom
28NCT02613182February 201627 May 2019Open-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.Not recruitingN/AN/AAll34Phase 2United States
29NCT02627820January 201622 August 2016The 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.Not recruiting50 Years90 YearsBoth0Phase 2
30EUCTR2015-002231-18-GB01/12/201518 April 2016A 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: 18.0 Level: LLT Classification code 10024460 Term: Light chain disease myeloma associated System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: CHX-A-DTPA-Anti-CD66
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CHX A-DTPA anti-CD66 antibody
Concentration unit: MBq/kg megabecquerel(s)/kilogram
Concentration type: equal
Product Name: Indium­ 111 ­labelled Anti­-CD66
Pharmaceutical Form: Infusion
INN or Proposed INN: Indium 111-radiolabelled anti-CD66
Concentration unit: MBq/kg megabecquerel(s)/kilogram
Concentration type: equal
Product Name: yttrium-90 radiolabelled anti-CD66 antibody
Pharmaceutical Form: Infusion
INN or Proposed INN: Yttrium­90 radiolabelled anti­CD66
Concentration unit: MBq/kg megabecquerel(s)/kilogram
Concentration type: range
Concentration number: 2-5
University Southampton Hospital NHS Foundation TrustAuthorisedFemale: yes
Male: yes
18Phase 1/2aUnited Kingdom
No.TrialIDDate_
enrollement
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PhaseCountries
31NCT02545907October 201521 September 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, LondonNot recruiting18 YearsN/ABoth36Phase 1/Phase 2United Kingdom
32NCT02489500June 201516 December 2017Trial 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 CenterNot recruiting18 YearsN/AAll3Phase 3United States
33JPRN-UMIN0000197322015/03/312 April 2019A 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 HematologyNot Recruiting20years-oldNot applicableMale and Female60Phase 2Japan
34NCT01531751February 201511 June 2018High 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. MatteoNot recruiting18 YearsN/AFemale0Phase 2Italy
35NCT02312206February 201518 June 2018The 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.Not recruiting18 YearsN/AAll260Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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agemin
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PhaseCountries
36NCT02245867December 2, 201422 January 2018Study 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 EisenbergerNot recruiting21 YearsN/AAll31Phase 1United States
37EUCTR2014-001586-27-ES25/07/20147 December 2015Study 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 activityPatients with familial amyloid polyneuropathy (FAP), asymptomatic carriers and healthy volunteers
MedDRA version: 17.0 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tasmar
Pharmaceutical Form: Coated tablet
INN or Proposed INN: TOLCAPONE
CAS Number: 134308-13-7
Current Sponsor code: SOM0226
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
SOM Innovation Biotech SL (SOM Biotech)Not RecruitingFemale: yes
Male: yes
Spain
38EUCTR2013-004561-13-PT04/07/20147 May 2018Not 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-CS3Familial 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]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ISIS 420915
CAS Number: 1432726-13-0
Current Sponsor code: ISIS 420915
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Ionis Pharmaceuticals, IncAuthorisedFemale: yes
Male: yes
135Phase 3France;United States;Portugal;Argentina;Brazil;Spain;Germany;New Zealand;Italy;United Kingdom
39NCT02175004June 20142 September 2019Open-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.Not recruiting18 YearsN/AAll135Phase 3United States;Argentina;Brazil;France;Germany;Italy;Portugal;Spain;United Kingdom;New Zealand
40NCT01807286January 201423 May 2016Pomalidomide 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 CenterCelgeneNot recruiting18 YearsN/ABoth3Phase 1United States
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41JPRN-UMIN0000123192013/09/152 April 2019Imaging of systemic amyloidosis with 99mTc-aprotininCardiac 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 MedicineRecruiting20years-oldNot applicableMale and Female80Not selectedJapan
42NCT01777243May 13, 201320 August 2018A 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.Not recruiting18 Years70 YearsAll25Phase 1United Kingdom
43EUCTR2012-001831-30-GB22/04/201310 September 2018A 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-CS2Familial 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]
Product Name: Human Transthyretin Antisense Oligonucleotide
Product Code: ISIS 420915
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ISIS 420915
Current Sponsor code: ISIS 420915
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Ionis Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;United States;Argentina;Brazil;Spain;Bulgaria;Germany;New Zealand;Italy;United Kingdom
44NCT01849783April 4, 20134 March 2019Autologous 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)Not recruiting65 Years85 YearsAll41Phase 2United States
45NCT02015312April 201316 December 2017A 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 ResearchNot recruiting18 YearsN/AAll38Phase 2Germany
No.TrialIDDate_
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46NCT01737398March 15, 201322 July 2019Efficacy 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.Not recruiting18 Years82 YearsAll173Phase 2/Phase 3United States;Argentina;Brazil;France;Germany;Italy;New Zealand;Portugal;Spain;United Kingdom;Bulgaria
47NCT01728259March 201325 February 2019First-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)Not recruiting18 YearsN/AAll36Phase 1United States;Canada;New Zealand
48JPRN-UMIN0000083962012/08/012 April 2019A randomized, double-blind, placebo-controlled trial of diflunisal on familial amyloid polyneuropathypatients of familial amyloid polyneuropathyDiflunisal, 500mg / day, PO, 1 year
Parse, 500mg / day, PO, 1 year
Department of Neurology, Faculty of Life Sciences, Kumamoto UniversityNot Recruiting18years-old65years-oldMale and Female1Phase 3Japan
49NCT01222260June 201230 September 2019Bendamustine 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 UniversityCephalonNot recruiting18 YearsN/AAll40Phase 2United States
50NCT01570387June 201214 January 2019A 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: DexamethasoneVaishali SanchorawalaCelgene CorporationNot recruiting18 YearsN/AAll27Phase 1/Phase 2United States
No.TrialIDDate_
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51NCT01510613February 201211 June 2018Pomalidomide 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. MatteoNot recruiting18 YearsN/AAll28Phase 2Italy
52NCT01511263January 201211 June 2018Epigallocatechingallate (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. MatteoNot recruiting18 YearsN/AAll86Phase 2Italy
53JPRN-JapicCTI-11167807/11/20112 April 2019The 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.2075BOTH10Phase 3
54JPRN-UMIN0000066042011/11/012 April 2019Phase 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 HematologyNot Recruiting20years-old65years-oldMale and Female21Phase 1,2Japan
55NCT01435655November 201119 October 2017The 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: tafamidisPfizerNot recruiting20 Years75 YearsAll10Phase 3Japan
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56NCT01406314October 13, 201116 December 2017SAP 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: GSK2315698GlaxoSmithKlineNot recruiting18 Years80 YearsAll17Phase 1United Kingdom
57EUCTR2010-021445-42-NL31/08/201110 March 2014A 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 amyloidosisAL Amyloidosis
MedDRA version: 16.1 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
HOVON FoundationAuthorisedFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
58NCT01383759June 24, 201113 May 2019Bortezomib/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.Not recruiting18 YearsN/AAll20N/AUnited States
59NCT01273844March 1, 201116 December 2017Study 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 UniversityNot recruiting18 Years65 YearsAll21N/AChina
60NCT01199562December 20106 May 2019Infection 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)Not recruiting18 YearsN/AAll153Phase 3United States
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61NCT01078454November 201019 October 2017Melphalan 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)Not recruiting18 YearsN/AAll11Phase 3United States
62EUCTR2010-022395-31-IT07/10/201019 February 2018A 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 - NDAL amyloidosis
MedDRA version: 9.1 Level: HLGT Classification code 10035227
Trade Name: VELCADE
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Melphalan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Dexamethasone
Concentration unit: % percent
Concentration type: equal
Concentration number: .2-
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Melphalan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: Dexamethasone
Concentration unit: % percent
Concentration type: equal
Concentration number: .2-
E.M.N. - EUROPEAN MYELOMA NETWORKNot RecruitingFemale: yes
Male: yes
110Phase 3Sweden;Italy;United Kingdom;Germany;Denmark;Spain;Greece;Czech Republic
63EUCTR2009-014906-33-GB17/09/20104 August 2015A 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) - REVEALSystemic AL amyloidosis
MedDRA version: 14.1 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
Product Name: bortezomib
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib
CAS Number: 179324-69-7
Current Sponsor code: bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
Trade Name: Velcade
Product Name: bortezomib
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib
CAS Number: 179324-69-7
Current Sponsor code: bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
University College LondonNot RecruitingFemale: yes
Male: yes
52United Kingdom
64NCT01072773March 201019 October 2017Bortezomib, 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 ClinicNot recruiting18 YearsN/AAll2Phase 2United States
65NCT01083316September 200929 April 2019Bortezomib 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.Not recruiting18 YearsN/AAll35Phase 2United States
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66EUCTR2009-011535-12-DE26/08/20092 October 2012In preparationOpen-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin AmyloidosisTransthyretin Amyloidosis (ATTR)
MedDRA version: 14.1 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Name: Tafamidis meglumine
Product Code: Fx-1006A
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: tafamidis
CAS Number: 951395-08-7
Current Sponsor code: Fx-1006A
Other descriptive name: [d-glucitol, 1-deoxy-1-(methylamino)-, 2-(3,5-dichlorophenyl)-6-benzoxazolecarboxylate (1:1)]
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pfizer Inc.Not RecruitingFemale: yes
Male: yes
110Portugal;Germany;Argentina;France;Italy;United States;Sweden;Brazil
67NCT00890747August 200919 February 2015Sunitinib 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)Not recruiting18 YearsN/ABoth42Phase 1United States
68JPRN-UMIN0000018252009/04/012 April 2019Treatment of familial amyloid polyneuropathy (FAP) using diflunisalfamilial amyloid polyneuropathy (FAP)Orally administration of diflunisalShinshu UniversityNot Recruiting20years-oldNot applicableMale and Female30Not selectedJapan
69NCT00890552April 200916 December 2017A 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 CorporationNot recruiting18 YearsN/AAll25N/AUnited States
70NCT00807872December 200819 February 2015Radioimmunoimaging 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 DevelopmentNot recruiting21 Years90 YearsBoth40Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
71NCT01815086December 200819 February 2015Radioimmunoimaging 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 TennesseeNot recruiting21 Years90 YearsBoth30Phase 1United States
72NCT01409148November 200819 February 2015Radioimmunoimaging 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)Not recruiting21 Years90 YearsBoth38Phase 1United States
73EUCTR2008-001405-41-DE24/10/200818 March 2013A 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) - LEOMEXAL amyloidosisTrade Name: Revlimid
Pharmaceutical Form: Capsule*
Other descriptive name: Lenalidomide
Concentration unit: IU/mg international unit(s)/milligram
Concentration number: 5 mg-
Trade Name: Alkeran
Product Code: L01AA03
Pharmaceutical Form: Film-coated tablet
Other descriptive name: melphalan
Concentration unit: IU/mg international unit(s)/milligram
Concentration number: 2 mg-
Trade Name: Fortecortin
Pharmaceutical Form: Tablet
Other descriptive name: dexamethasone
Concentration unit: IU/mg international unit(s)/milligram
Concentration number: 4 mg-
GMIHO mbHNot RecruitingFemale: yes
Male: yes
Germany
74EUCTR2008-001262-87-PT04/07/200824 July 2012An Open-Label Extension of Study Fx-005 Evaluating Long-Term Safety and Clinical Outcomes of Fx-1006A in Patients with Transthyretin Amyloid Polyneuropathy - Not applicableTransthyretin Amyloid Polyneuropathy (ATTR-PN)
MedDRA version: 9.1 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy
Product Name: Fx-1006A
Product Code: Fx-1006A
Pharmaceutical Form: Capsule, soft
CAS Number: 951395-08-7
Current Sponsor 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
FoldRx Pharmaceuticals, Inc.Not RecruitingFemale: yes
Male: yes
107Portugal;Germany;France;Sweden
75NCT00791492July 200819 October 2017An 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-1006APfizerNot recruiting18 Years75 YearsAll86Phase 2/Phase 3Argentina;Brazil;France;Germany;Portugal;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
76NCT00790647June 200819 October 2017Melphalan, 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 CenterNot recruiting18 Years65 YearsAll10Phase 2United States
77NCT00679367May 200819 October 2017Melphalan, 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 CenterNot recruiting18 YearsN/AAll16Phase 2United States
78EUCTR2007-006037-13-IT21/02/200826 June 2012An 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 - NDamyloidosis AL
MedDRA version: 6.1 Level: PT Classification code 10002022
Trade Name: Revlimid
Pharmaceutical Form: Capsule, hard
Current Sponsor code: CC-5013
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical Form: Tablet
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical Form: Oral solution
INN or Proposed INN: Dexamethasone
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
OSPEDALE POLICLINICO S. MATTEONot RecruitingFemale: yes
Male: yes
Phase 2Italy
79NCT00607581February 200819 February 2015Cyclophosphamide, 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 CorporationNot recruiting18 YearsN/ABoth21Phase 2Italy
80NCT00981708February 200819 February 2015Lenalidomide, 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 GroupNot recruiting18 YearsN/ABoth37Phase 1/Phase 2Greece
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
81NCT00564889December 200719 October 2017Lenalidomide, 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)Not recruiting18 YearsN/AAll35Phase 2United States
82NCT01998503December 200719 February 2015Bortezomib 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 MedicineNot recruiting18 Years65 YearsBoth56Phase 3China
83EUCTR2006-007082-36-GR16/10/200719 March 2012A 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 amyloidosisPrimary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatmentsTrade Name: REVLIMID
Pharmaceutical Form: Capsule*
Trade Name: Endoxan
Pharmaceutical Form: Tablet
Trade Name: Dexamethasone
Pharmaceutical Form: Tablet
Trade Name: REVLIMID
Pharmaceutical Form: Capsule*
INN or Proposed INN: Lenalidomide
CAS Number: 191732-72-6
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-25
INN or Proposed INN: Deaxamethasone
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: cyclophosphamide
CAS Number: 50-18-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Hellenic Oncology Cooperative GroupNot RecruitingFemale: yes
Male: yes
55Phase 1/2Greece
84NCT00520767September 200716 December 2017Bortezomib, 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)Not recruiting18 Years120 YearsAll35Phase 2United States
85NCT00458822February 200719 October 2017Melphalan 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)Not recruiting18 Years70 YearsAll40Phase 2United States
No.TrialIDDate_
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PhaseCountries
86NCT00409175January 200719 October 2017Safety 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: PlaceboPfizerNot recruiting18 Years75 YearsAll128Phase 2/Phase 3United States;Argentina;Brazil;France;Germany;Portugal;Spain;Sweden;United Kingdom
87EUCTR2006-002792-41-SE30/10/200619 March 2012Safety 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 StudyFamilial Amyloid Polyneuropathy (FAP).
MedDRA version: 9.1 Level: LLT Classification code 10057949 Term: Familial amyloid polyneuropathy
Product Code: Fx-1006A
Pharmaceutical Form: Capsule, soft
Current Sponsor 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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
FoldRx Pharmaceuticals LimitedNot RecruitingFemale: yes
Male: yes
120Phase 2/3Portugal;Germany;United Kingdom;Spain;Sweden
88NCT00536601June 29, 200620 August 2018High-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)Not recruiting4 YearsN/AAll174N/AUnited States
89NCT00294671February 200616 December 2017The 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)Not recruiting18 Years75 YearsAll130Phase 2/Phase 3United States;Italy;Japan;Sweden;United Kingdom;Portugal
90NCT00477971October 200519 October 2017Low-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)Not recruiting18 YearsN/AAll89Phase 3United States
No.TrialIDDate_
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PhaseCountries
91EUCTR2004-004871-12-IT02/05/20052 October 2012An 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)-AmyloidosisSystemic AL-Amyloidosis
MedDRA version: 6.1 Level: PT Classification code 10002022
Trade Name: VELCADE*1FL 3,5MG
Product Name: NA
Product Code: NA
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Bortezomib
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-
JANSSEN-CILAGNot RecruitingFemale: yes
Male: yes
Phase 1/2Italy
92NCT00166413April 200519 February 2015Efficacy 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 ClinicNot recruiting18 YearsN/ABoth38Phase 2United States
93NCT00064337January 200416 December 2017S0115, 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)Not recruiting18 Years120 YearsAll104Phase 2United States
94NCT00091260January 200419 October 2017CC-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 CorporationNot recruiting18 YearsN/AAll82Phase 2United States
95NCT00052884October 200319 February 2015Amifostine 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)Not recruiting18 Years70 YearsBoth8Phase 1United States
No.TrialIDDate_
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96NCT01527032September 20027 April 2015Risk-adapted Therapy for Primary Systemic (AL) AmyloidosisRisk-adapted Therapy for AL AmyloidosisAmyloidosisDrug: melphalan, thalidomide and dexamethasoneFDA Office of Orphan Products DevelopmentNot recruitingPhase 2
97NCT00089167May 200219 February 2015Melphalan, 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)Not recruiting18 YearsN/ABothPhase 2United States
98NCT00030381December 200119 February 2015Iododoxorubicin 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)Not recruiting18 YearsN/ABoth22Phase 1United States
99NCT00025415August 200119 February 2015Imatinib 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)Not recruiting15 YearsN/ABoth60Phase 1United States
100NCT00075608August 200119 October 20172nd 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 CenterNot recruiting18 Years65 YearsAll12Phase 2United States
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101NCT00224393February 200119 February 2015Phase II Trial of Enbrel in Patients With Primary Systemic AmyloidosisPrimary Systemic AmyloidosisDrug: EnbrelThe Cleveland ClinicNot recruiting18 YearsN/ABoth60Phase 2
102NCT00014235December 200018 December 2018Fludarabine 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 ImmunosuppressionSplenic 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 Macroglobulinemia;Acute 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 LymphomaDrug: 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)Not recruitingN/A74 YearsAll160N/AGermany;Italy;United States
103NCT00075621August 200024 June 2019Tandem 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 CenterNot recruiting18 Years65 YearsAll62Phase 2United States
104NCT00006251May 200026 November 2018Fludarabine 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 MacroglobulinemiaDrug: mycophenolate mofetil;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Biological: donor lymphocytes;Procedure: peripheral blood stem cell transplantation;Other: laboratory biomarker analysis;Radiation: total-body irradiation;Drug: fludarabine phosphate;Drug: cyclosporineFred Hutchinson Cancer Research CenterNational Cancer Institute (NCI)Not recruitingN/A74 YearsAll21Phase 1/Phase 2United States;Italy;Germany
105NCT00344526January 200019 February 2015Intensive 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, FranceNot recruiting18 Years70 YearsBoth100Phase 3France
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106NCT00112593November 199916 December 2017Fludarabine 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)Not recruitingN/A75 YearsAll5N/AUnited States
107NCT00007995July 199919 February 2015Chemotherapy 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)Not recruiting18 YearsN/ABoth75Phase 2United States
108NCT00003853April 199919 February 20154'-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)Not recruiting18 YearsN/ABoth45Phase 2United States;Italy
109NCT00003353July 199819 February 2015High-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)Not recruiting18 Years70 YearsBothPhase 2United States
110NCT00002849November 199616 March 2015S9628 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 BNot recruiting18 YearsN/ABoth93Phase 2United States
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111JPRN-JapicCTI-18392916 July 2019A 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 AmyloidosisAmyloidosisIntervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab
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
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.Recruiting20BOTH40Phase 3

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