Dexamethason ( DrugBank: - )


4 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica3
28Systemic amyloidosis87
46Malignant rheumatoid arthritis3
331Idiopathic multicentric castleman disease1

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05232825
(ClinicalTrials.gov)
May 3, 202227/1/2022A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple SclerosisA Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple SclerosisRelapsing Multiple Sclerosis;Primary Progressive Multiple SclerosisDrug: Ocrelizumab IV;Drug: Ocrelizumab SC;Drug: Methylprednisolone IV;Drug: Diphenhydramine IV;Drug: Dexamethasone given orally;Drug: Desloratadine given orallyHoffmann-La RocheNULLActive, not recruiting18 Years65 YearsAll234Phase 3United States;Australia;Brazil;Czechia;Italy;New Zealand;Poland;Spain;Turkey;Canada;Russian Federation;Ukraine
2NCT00674141
(ClinicalTrials.gov)
July 20086/5/2008Nasal Administration of Dexamethasone for Multiple Sclerosis (MS) TreatmentNasal Administration of Dexamethasone for MS TreatmentMS Patient With Relpasing Remitting AttacksDrug: Dexamethasone soduim phosphateHadassah Medical OrganizationNULLWithdrawn18 YearsN/ABoth10Phase 1Israel
3EUCTR2006-003113-40-NL
(EUCTR)
18/08/200621/07/2006Dexamethason for the treatment of exacerbations in multiple sclerosisDexamethason for the treatment of exacerbations in multiple sclerosis Multiple Sclerosis
MedDRA version: 8.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Dexamethason
INN or Proposed INN: Dexamethasone
Department of Neurology UMCGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Netherlands

28. Systemic amyloidosis


Clinical trials : 267 Drugs : 241 - (DrugBank : 77) / Drug target genes : 68 - Drug target pathways : 180
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05486481
(ClinicalTrials.gov)
April 1, 20231/8/2022Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE)A Multicenter Phase 1/2 Study of Venetoclax / Daratumumab / Dexamethasone for Previously Treated Systemic Light-Chain Amyloidosis Patients With Translocation (11;14) (ALTITUDE STUDY)AL Amyloidosis;Light Chain (AL) Amyloidosis;Systemic Light Chain DiseaseDrug: Venetoclax;Drug: Dexamethasone;Drug: DaratumumabSandy Wong, MDJanssen Pharmaceuticals;AbbVieNot yet recruiting18 YearsN/AAll78Phase 1/Phase 2United States
2NCT05451771
(ClinicalTrials.gov)
October 26, 20226/7/2022Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) AmyloidosisAn Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain AmyloidosisAL AmyloidosisDrug: Venetoclax Oral Tablet, 200 mg;Device: FISH assay;Drug: Venetoclax Oral Tablet, 400 mg;Drug: Dexamethasone Oral, 10 mg;Drug: Dexamethasone Oral, 20 mg;Drug: Daratumumab Injection;Drug: Bendamustine;Drug: Pomalidomide;Drug: Ixazomib;Drug: Venetoclax MTD with DexamethasoneRajshekhar Chakraborty, MDGenentech, Inc.Recruiting18 YearsN/AAll53Phase 1/Phase 2United States
3JPRN-jRCT2031220037
20/06/202223/04/2022A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL AmyloidosisA Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis - AFFIRM-AL Light Chain (AL) Amyloidosis- Birtamimab group:
Intravenous administration of 24 mg/kg birtamimab every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy
- Placebo group:
Intravenous 0.9% Saline administration as a placebo every 28 days. Bortezomib-containing chemotherapy regimen (e.g. cyclophosphamide, bortezomib, and dexamethasone (CyBorD)) according to the institutional standard of care is co-administered as Standard of Care Chemotherapy
Nie ChristieNULLRecruiting>= 18age oldNot applicableBoth16Phase 3Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Republic of Korea;Netherlands;New Zealand;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;United States;Japan
4NCT05066607
(ClinicalTrials.gov)
February 11, 202224/8/2021Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous TherapyA Phase 2, Open Label, Multicenter, Single-stage Study to Evaluate the Efficacy of Isatuximab Plus Pomalidomide and Dexamethasone (IPd), in Patients With AL Amyloidosis Not in VGPR or Better After Any Previous TherapyAL AmyloidosisDrug: IsatuximabIntergroupe Francophone du MyelomeSanofi;Bristol-Myers SquibbRecruiting18 YearsN/AAll46Phase 2France
5NCT04984330
(ClinicalTrials.gov)
December 202129/7/2021Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory DiseaseSelinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory DiseaseAmyloid;Amyloidosis;AL AmyloidosisDrug: Selinexor;Drug: DexamethasoneWeill Medical College of Cornell UniversityKaryopharm Therapeutics IncWithdrawn18 YearsN/AAll0Early Phase 1United States
6NCT04754945
(ClinicalTrials.gov)
April 28, 20219/2/2021Isatuximab as Upfront Therapy for the Treatment of High Risk AL AmyloidosisSlow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront TherapyAL AmyloidosisDrug: Bortezomib;Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: IsatuximabEmory UniversitySanofi;National Cancer Institute (NCI)Recruiting18 YearsN/AAll25Phase 1United States
7NCT04270175
(ClinicalTrials.gov)
April 14, 202112/2/2020Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabDaratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to DaratumumabAmyloid;AL Amyloidosis;Refractory AL AmyloidosisDrug: Daratumumab;Drug: Pomalidomide;Drug: DexamethasoneWeill Medical College of Cornell UniversityJanssen Scientific Affairs, LLCRecruiting18 YearsN/AAll21Phase 2United States
8NCT04504825
(ClinicalTrials.gov)
February 2, 202120/7/2020A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimenAlexionNULLRecruiting18 YearsN/AAll124Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Switzerland;United Kingdom
9NCT04512235
(ClinicalTrials.gov)
November 12, 202010/8/2020A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL AmyloidosisA Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimenAlexionNULLRecruiting18 YearsN/AAll267Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom
10NCT04115956
(ClinicalTrials.gov)
August 6, 202029/8/2019A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) AmyloidosisAn Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of TherapyAL AmyloidosisDrug: Melphalan-Flufenamide (Melflufen);Drug: DexamethasoneOncopeptides ABPRA Health SciencesTerminated18 YearsN/AAll6Phase 1/Phase 2United States;Czechia;France;Germany;Greece;Israel;Norway;Spain;United Kingdom;Italy;Poland
11NCT04304144
(ClinicalTrials.gov)
March 18, 202028/2/2020A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisCAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL AmyloidosisAL AmyloidosisDrug: CAEL-101;Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: DaratumumabAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll25Phase 2United States
12EUCTR2018-002761-19-DE
(EUCTR)
06/03/202012/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
13EUCTR2018-002761-19-ES
(EUCTR)
05/02/202009/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis.Patients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy
14NCT04612582
(ClinicalTrials.gov)
January 1, 202015/6/2020Comparison of BTD and BCD Based Regimens in the Treatment of AL AmyloidosisA Comparative Study of Bortezomib-Thalidomide-Dexamethason and Bortezomib-Cyclophosphamide-Dexamethason in the Treatment of Monoclonal Immunoglobulin Light Chain Amyloidosis: A Prospective Randomized Controlled Trial(BTD-CHINA-TRIAL)Immunoglobulin Light-Chain AmyloidosisDrug: Thalidomide;Drug: CyclophosphamideGuangdong Provincial People's HospitalNULLRecruiting18 Years80 YearsAll70Phase 4China
15EUCTR2018-002761-19-GR
(EUCTR)
03/12/201915/11/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
16EUCTR2018-002761-19-NO
(EUCTR)
15/11/201901/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy
17EUCTR2018-002761-19-IT
(EUCTR)
25/10/201929/01/2021It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis. Patients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy - NA Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
Product Code: [Melflufen]
INN or Proposed INN: melphalan fulfenamide hydrochloride
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: [H02AB02]
INN or Proposed INN: DESAMETASONE
ONCOPEPTIDES ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 1;Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
18EUCTR2018-002761-19-PL
(EUCTR)
24/10/201907/08/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLNot RecruitingFemale: yes
Male: yes
46Phase 2France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy
19EUCTR2018-002761-19-CZ
(EUCTR)
21/10/201931/07/2019It is an early clinical trial to assess a new drug (Melflufen) when giventogether with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL AmyloidosisPatients should also have received treatment in the past for the disease.An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy Patients with AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Melflufen
INN or Proposed INN: melphalan fulfenamide hydrochloride
Other descriptive name: MELFLUFEN
Trade Name: Dexamethasone 4 mg JENAPHARM
Product Name: Dexamethasone
Product Code: H02AB02
INN or Proposed INN: DEXAMETHASONE
Oncopeptides ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 2France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom
20EUCTR2018-004333-33-IT
(EUCTR)
01/08/201928/04/2020Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis - EMN22/54767414AMY2005 Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
INN or Proposed INN: DARATUMUMAB
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
Product Name: Decadron
Product Code: H02AB02 Desametasone
INN or Proposed INN: DEXAMETHASONE
Other descriptive name: Dexamethasone
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
21EUCTR2016-001737-27-GB
(EUCTR)
08/10/201811/01/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
22EUCTR2016-001737-27-PL
(EUCTR)
06/09/201816/07/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;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
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of;Sweden
23EUCTR2016-001737-27-DK
(EUCTR)
22/08/201804/06/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Denmark;Australia;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
24NCT03618537
(ClinicalTrials.gov)
August 2, 20182/8/2018Ixazomib Maintenance Study in Patients With AL AmyloidosisIxazomib Maintenance Following Initial Therapy in Patients With Immunoglobulin Light Chain (AL) AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: DexamethasoneMemorial Sloan Kettering Cancer CenterTufts Medical Center;Vanderbilt University Medical CenterRecruiting18 YearsN/AAll47Phase 2United States
25JPRN-JapicCTI-183929
17/7/201813/04/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AmyloidosisIntervention name : Cyclophosphamide, Bortezomib, dexamethasone plus Daratumumab
INN of the intervention : -
Dosage And administration of the intervention : Participants will receive dexamethasone (20mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing) followed by 1800 mg of daratumumab subcutaneously followed by cyclophosphamide (300 mg/m^2 orally or IV dose weekly) and bortezomib (1.3 mg/m^2 subcutaneous injection weekly) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab will be administered weekly for the first 8 weeks (2 cycles), then every 2 weeks for 4 cycles (cycles 3-6), and then every 4 weeks until progression of disease or subsequent therapy for a maximum of 2 years.
Control intervention name : Cyclophosphamide, Bortezomib, dexamethasone
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive dexamethasone (40milligrams [mg] orally or intravenous [IV]dose), followed by cyclophosphamide (300milligram per meter square [mg/m^2] orally or IV dose), then bortezomib (1.3 mg/m^2 subcutaneous injection) weekly on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles.
Janssen Pharmaceutical K.K.NULLcomplete20BOTH370Phase 4Japan, Asia except Japan, North America, Europe
26EUCTR2016-001737-27-SE
(EUCTR)
07/05/201820/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
27EUCTR2016-001737-27-GR
(EUCTR)
16/04/201822/03/2018A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;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
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
28EUCTR2016-001737-27-DE
(EUCTR)
16/04/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
29EUCTR2016-001737-27-NL
(EUCTR)
15/03/201829/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
370 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden
30NCT03130348
(ClinicalTrials.gov)
March 15, 201821/4/2017Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain AmyloidosisPhase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain AmyloidosisAmyloidosis;Immunoglobulin Light Chain DepositionDrug: Bortezomib;Drug: Dexamethasone;Drug: Ibrutinib;Other: Laboratory Biomarker AnalysisMayo ClinicNational Cancer Institute (NCI)Withdrawn18 YearsN/AAll0Phase 2United States
31EUCTR2016-001737-27-IT
(EUCTR)
01/03/201817/06/2021A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis - ANDROMEDA AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis)
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: daratumumab coformulato con ialuronidasi umana ricombinante (rHuPH20)
Product Code: [JnJ 54767414]
INN or Proposed INN: Daratumumab
Other descriptive name: HUMAX-CD38
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Australia;Denmark;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of
32NCT03283917
(ClinicalTrials.gov)
February 7, 201813/9/2017Daratumumab, Ixazomib, and Dexamethasone in AL AmyloidosisA Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL AmyloidosisNewly Diagnosed Primary Amyloidosis;Recurrent Primary Amyloidosis;Refractory Primary AmyloidosisBiological: Daratumumab;Drug: Dexamethasone;Drug: IxazomibM.D. Anderson Cancer CenterJanssen Pharmaceuticals;TakedaRecruiting18 YearsN/AAll20Phase 1United States
33EUCTR2016-001737-27-ES
(EUCTR)
06/02/201823/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;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
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
34EUCTR2016-001737-27-HU
(EUCTR)
25/01/201828/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;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
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
35EUCTR2016-001737-27-BE
(EUCTR)
16/01/201816/11/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JnJ 54767414
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
370Phase 3United States;Greece;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Romania;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of;Sweden
36NCT03201965
(ClinicalTrials.gov)
October 5, 201727/6/2017A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) AmyloidosisA Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic AL AmyloidosisAmyloidosisDrug: Cyclophosphamide;Drug: Bortezomib;Drug: Dexamethasone, 40 mg;Drug: DaratumumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll416Phase 3Canada;China;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Spain;Sweden;Turkey;United Kingdom;United States;Romania;Australia;Belgium;Brazil
37ChiCTR-IPR-17012637
2017-10-012017-09-11Prospective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosisProspective Randomized controlled study of the combination regimen of bortezomib + thalidomide + dexamethasone (VTD) and bortezomib + cyclophosphamide + dexamethasone (VCD) for the initial treatment of type AL amyloidosis type AL amyloidosisGroup 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD);Guangdong General HospitalNULLPending1875BothGroup 1:35;Group 2:35;China
38NCT03252600
(ClinicalTrials.gov)
August 25, 201724/7/2017Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary AmyloidosisA Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL AmyloidosisRecurrent Primary AmyloidosisDrug: Cyclophosphamide;Drug: Dexamethasone;Biological: Elotuzumab;Other: Laboratory Biomarker Analysis;Drug: Lenalidomide;Other: Pharmacological StudyBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI);Bristol-Myers Squibb;Multiple Myeloma Research ConsortiumActive, not recruiting18 YearsN/AAll53Phase 2United States
39NCT03236792
(ClinicalTrials.gov)
June 12, 201720/7/2017Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL AmyloidosisPhase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL AmyloidosisAL AmyloidosisDrug: Ixazomib;Drug: Cyclophosphamide;Drug: DexamethasoneIcahn School of Medicine at Mount SinaiMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll28Phase 1/Phase 2United States
40NCT03000660
(ClinicalTrials.gov)
January 201712/12/2016Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL AmyloidosisA Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL AmyloidosisAL AmyloidosisDrug: Venetoclax;Drug: DexamethasoneTufts Medical CenterNULLTerminated18 YearsN/AAll3Phase 1United States
41ChiCTR-IPR-16008422
2016-05-052016-05-08Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL)Randomized controlled study of the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD) and bortezomib +thalidomide + dexamethasone (BTD) for the initial treatment of primary systemic amyloidosis (AL) primary systemic amyloidosis (AL)the first group: the combination regimen of bortezomib + cyclophosphamide + dexamethasone (BCD);the second group:the combination regimen of bortezomib +thalidomide + dexamethasone (BTD) ;People's Hospital, Beijing UniversityNULLRecruiting1875Boththe first group:60;the second group:60;China
42NCT02545907
(ClinicalTrials.gov)
October 201527/8/2015A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL AmyloidosisA Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL AmyloidosisAmyloidosisDrug: Carfilzomib;Drug: Thalidomide;Drug: DexamethasoneUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth36Phase 1/Phase 2United Kingdom
43NCT01807286
(ClinicalTrials.gov)
January 20146/3/2013Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL AmyloidosisA Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase IMyelomaDrug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: QuestionnairesM.D. Anderson Cancer CenterCelgeneTerminated18 YearsN/ABoth3Phase 1United States
44EUCTR2010-022395-31-CZ
(EUCTR)
01/10/201317/07/2013A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis.A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis. AL Amyloidosis
MedDRA version: 16.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Trade Name: ALKERAN
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
Trade Name: FORTECORTIN
Product Name: dexamethasone
Product Code: A01AC02
INN or Proposed INN: DEXAMETHASONE
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
45NCT01849783
(ClinicalTrials.gov)
April 4, 20136/5/2013Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple MyelomaSingle Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell MalignancyExtramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple MyelomaDrug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplantYogesh JethavaNational Cancer Institute (NCI)Active, not recruiting65 Years85 YearsAll41Phase 2United States
46NCT01728259
(ClinicalTrials.gov)
March 201313/11/2012First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDDPhase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition DiseaseLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: pomalidomide;Drug: bortezomib;Drug: dexamethasone;Other: Laboratory Biomarker AnalysisBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 YearsN/AAll36Phase 1United States;Canada;New Zealand
47NCT01222260
(ClinicalTrials.gov)
January 201314/10/2010Bendamustine and Dexamethasone in Patients With Relapsed AL AmyloidosisPhase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL AmyloidosisAL AmyloidosisDrug: Bendamustine;Drug: DexamethasoneColumbia UniversityCephalonCompleted18 YearsN/AAll40Phase 2United States
48EUCTR2010-022395-31-DE
(EUCTR)
25/10/201218/10/2012Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone for untreated patients with systemic light-chain (AL) amyloidosisA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - AC-004-EU AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
Trade Name: Fortecortin
Product Name: Dexamethason
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
European Myeloma NetworkNULLNot RecruitingFemale: yes
Male: yes
110Phase 3France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
49EUCTR2010-022395-31-ES
(EUCTR)
13/06/201221/05/2012A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosisA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Other descriptive name: VELCADE
Trade Name: Dexamethasone
Product Name: Dexamethasone
Product Code: Dexametasone
Other descriptive name: DEXAMETHASONE
Trade Name: melphalan
Product Name: Melphalan
Product Code: melphalan
INN or Proposed INN: MELPHALAN
Trade Name: betamethasone
Product Name: Dexamethasone
INN or Proposed INN: oral drops solution
Other descriptive name: DEXAMETHASONE
Trade Name: melphalan
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
E.M.N. - EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Germany;Netherlands;Denmark;Norway;France;Spain;Italy;Greece;Sweden
50NCT01570387
(ClinicalTrials.gov)
June 201227/2/2012A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisA Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL AmyloidosisAL AmyloidosisDrug: Pomalidomide;Drug: DexamethasoneBoston Medical CenterCelgene CorporationCompleted18 YearsN/AAll27Phase 1/Phase 2United States
51EUCTR2010-021445-42-BE
(EUCTR)
10/05/201210/10/2011A study in which is investigated if the medicine bortezomib is effective in patietns with AL amylodosis.A multicenter, randomized phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis AL Amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
HOVON FoundationNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
52EUCTR2010-021445-42-DE
(EUCTR)
09/05/201223/01/2012A study to investigated whether bortezomib is effective in patients with AL amyloidosisA multicenter, prospective study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL Amyloidosis AL Amyloidosis
MedDRA version: 17.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
Trade Name: Fortecortin
Product Name: Fortecortin
INN or Proposed INN: Dexamethasone
Trade Name: Fortecortin
Product Name: Fortecortin
INN or Proposed INN: Dexamethasone
HOVON FoundationNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Belgium;Netherlands;Germany
53EUCTR2011-001787-22-IT
(EUCTR)
02/05/201212/01/2012Treatment with pomalidomide and dexamethasone for previously treated patients with AL amyloidosis.An open-label, phase II study of Pomalidomide and Dexamethasone (PDex) for previously treated patients with AL amyloidosis - PDex Previously treated AL amyloidosis
MedDRA version: 14.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: pomalidomide
Product Code: CC-4047
INN or Proposed INN: Pomalidomide
INN or Proposed INN: DEXAMETHASONE SODIUM SULFATE
OSPEDALE POLICLINICO S. MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
54EUCTR2010-022395-31-GR
(EUCTR)
02/05/201202/04/2012N/AN/A - BMDex vs MDex for AL amyloidosis Primary Systemic (AL) Amyloidosis
MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: VELCADE
INN or Proposed INN: BORTEZOMIB
Trade Name: Dexaton
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
Trade Name: Dexaton
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Trade Name: Alkeran
INN or Proposed INN: MELPHALAN
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia
55NCT01510613
(ClinicalTrials.gov)
February 201211/1/2012Pomalidomide and Dexamethasone (PDex) in AL AmyloidosisAn Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis.Primary Amyloidosis of Light Chain TypeDrug: Pomalidomide and DexamethasoneIRCCS Policlinico S. MatteoNULLCompleted18 YearsN/AAll28Phase 2Italy
56EUCTR2010-022395-31-DK
(EUCTR)
14/11/201109/06/2011A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 14.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: VELCADE
Product Name: bortezomib
Product Name: Dexamethasone
Trade Name: Alkeran
Product Name: Melphalan
Product Name: Dexamethasone
Product Name: Melphalan
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden
57JPRN-UMIN000006604
2011/11/0124/10/2011Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis.Phase 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. - BMD treatment for relapsed or refractory systemic AL amyloidosis. To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.Patients receive oral melphalan 8 mg/m2 on days 1-4, bortezomib SC (IV) on days 1, 4, 8 and 11, and dexamethasone orally on days 1-2, 4-5 8-9 11 and 12. Treatment repeats every 4 weeks (28 days) for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
*The preventive medication on last medication day after the 28th is recommended in principle from acyclovir 200 or 400 mg/the bortezomib medication opening day of a day.
Moreover, when the symptoms of herpes are shown, the acyclovir or the rose cyclo building of a therapeutic amount is promptly prescribed for the patient.
Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of HematologyNULLComplete: follow-up complete20years-old65years-oldMale and Female21Phase 1,2Japan
58EUCTR2010-021445-42-NL
(EUCTR)
31/08/201127/01/2011A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosisA multicenter, phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis AL Amyloidosis
MedDRA version: 16.1;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Trade Name: Velcade
INN or Proposed INN: BORTEZOMIB
HOVON FoundationNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Belgium;Germany;Netherlands
59NCT01383759
(ClinicalTrials.gov)
June 24, 201127/6/2011Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisPilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and AL AmyloidosisLight Chain Deposition Disease (LCDD or MIDD);Light Chain and Heavy Chain Deposition Disease (LHCDD or MIDD);Monoclonal Immunoglobulin Deposition Disease (MIDD);AmyloidosisDrug: Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/DexamethasoneMemorial Sloan Kettering Cancer CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll20N/AUnited States
60EUCTR2010-022395-31-SE
(EUCTR)
10/06/201112/04/2011A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis AL Amyloidosis
MedDRA version: 13.1;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders
Trade Name: VELCADE
Product Name: Dexamethasone
Product Name: Melphalan
Product Name: Dexamethasone
Product Name: Melphalan
E.M.N. - EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 3United Kingdom;Denmark;Spain;Italy;Greece;Sweden
61NCT01273844
(ClinicalTrials.gov)
March 1, 20113/1/2011Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL)Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in ALAmyloidosisDrug: BortezomibZhi-Hong Liu, M.D.Soochow University;Nanjing Medical UniversityCompleted18 Years65 YearsAll21N/AChina
62NCT01277016
(ClinicalTrials.gov)
January 201110/1/2011A Trial for Systemic Light-chain (AL) AmyloidosisA Randomized Open-label Multicenter Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-chain (AL) AmyloidosisAL AmyloidosisDrug: BMDexEuropean Myeloma NetworkNULLCompleted18 YearsN/AAll110Phase 3Italy
63NCT01078454
(ClinicalTrials.gov)
November 201027/2/2010Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain AmyloidosisA Randomized Phase III Trial of Melphalan and Dexamethasone (MDex) Versus Bortezomib, Melphalan and Dexamethasone (BMDex) for Untreated Patients With Systemic Light-Chain (AL) Amyloidosis Ineligible for Autologous Stem-Cell TransplantationLight Chain Deposition Disease;Primary Systemic AmyloidosisDrug: melphalan;Drug: dexamethasone;Drug: bortezomibNational Cancer Institute (NCI)NULLCompleted18 YearsN/AAll11Phase 3United States
64EUCTR2010-022395-31-IT
(EUCTR)
07/10/201001/12/2010A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - NDA randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis - ND AL amyloidosis
MedDRA version: 9.1;Level: HLGT;Classification code 10035227
Trade Name: VELCADE
INN or Proposed INN: Bortezomib
INN or Proposed INN: Melphalan
INN or Proposed INN: Dexamethasone
INN or Proposed INN: Melphalan
INN or Proposed INN: Dexamethasone
E.M.N. - EUROPEAN MYELOMA NETWORKNULLNot RecruitingFemale: yes
Male: yes
110Phase 3Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden
65NCT01194791
(ClinicalTrials.gov)
October 201026/7/2010Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly DiagnosedA Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell TransplantationPrimary Systemic AmyloidosisDrug: Lenalidomide;Drug: Cyclophosphamide;Drug: DexamethasonePETHEMA FoundationNULLCompleted18 YearsN/AAll30Phase 2Spain
66NCT01072773
(ClinicalTrials.gov)
March 201017/2/2010Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain AmyloidosisPhase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain AmyloidosisPrimary Systemic AmyloidosisDrug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasoneMayo ClinicNULLCompleted18 YearsN/AAll2Phase 2United States
67NCT01083316
(ClinicalTrials.gov)
September 20092/11/2009Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) AmyloidosisPhase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: Dexamethasone;Drug: MelphalanBoston Medical CenterMillennium Pharmaceuticals, Inc.Completed18 YearsN/AAll35Phase 2United States
68NCT00890552
(ClinicalTrials.gov)
April 200928/4/2009A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisA Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL AmyloidosisLeukemia;AmyloidosisDrug: Lenalidomide;Drug: Melphalan;Drug: DexamethasoneStanford UniversityCelgene CorporationCompleted18 YearsN/AAll25N/AUnited States
69NCT00883623
(ClinicalTrials.gov)
April 200915/4/2009A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) AmyloidosisA Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL AmyloidosisPrimary AmyloidosisDrug: LenalidomideHeidelberg UniversityGesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbHCompleted18 Years74 YearsBoth50Phase 2Germany
70EUCTR2008-001405-41-DE
(EUCTR)
24/10/200828/08/2008A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEXA prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX AL amyloidosisTrade Name: Revlimid
Other descriptive name: Lenalidomide
Trade Name: Alkeran
Product Code: L01AA03
Other descriptive name: melphalan
Trade Name: Fortecortin
Other descriptive name: dexamethasone
GMIHO mbHNULLNot RecruitingFemale: yes
Male: yes
Germany
71NCT00679367
(ClinicalTrials.gov)
May 200814/5/2008Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomide;Drug: melphalanBoston Medical CenterNULLCompleted18 YearsN/AAll16Phase 2United States
72EUCTR2007-006037-13-IT
(EUCTR)
21/02/200810/12/2007An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - NDAn open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND amyloidosis AL
MedDRA version: 6.1;Level: PT;Classification code 10002022
Trade Name: Revlimid
INN or Proposed INN: Cyclophosphamide
INN or Proposed INN: Dexamethasone
OSPEDALE POLICLINICO S. MATTEONULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
73NCT00981708
(ClinicalTrials.gov)
February 200819/9/2009Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic AmyloidosisAmyloidosisDrug: Lenalidomide, Dexamethasone and CyclophosphamideUniversity of AthensHellenic Cooperative Oncology GroupCompleted18 YearsN/AAll37Phase 1/Phase 2Greece
74NCT00607581
(ClinicalTrials.gov)
February 200822/1/2008Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAn Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL AmyloidosisAmyloidosisDrug: cyclophosphamide;Drug: lenalidomide;Drug: dexamethasoneIRCCS Policlinico S. MatteoCelgene CorporationCompleted18 YearsN/ABoth21Phase 2Italy
75NCT00564889
(ClinicalTrials.gov)
December 200728/11/2007Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: cyclophosphamide;Drug: dexamethasone;Drug: lenalidomideMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll35Phase 2United States
76NCT01998503
(ClinicalTrials.gov)
December 200715/11/2013Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL AmyloidosisInduction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL AmyloidosisAmyloidosisDrug: Bortezomib;Drug: dexamethasone;Biological: filgrastim;Procedure: autologous hematopoietic stem cell transplantation (ASCT);Drug: MelphalanNanjing University School of MedicineNULLCompleted18 Years65 YearsBoth56Phase 3China
77EUCTR2006-007082-36-GR
(EUCTR)
16/10/200718/07/2007A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosisA Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis Primary (AL) amyloidosis in untreated patients or patientsw who have failed prior treatmentsTrade Name: REVLIMID
Trade Name: Endoxan
Trade Name: Dexamethasone
Trade Name: REVLIMID
INN or Proposed INN: Lenalidomide
INN or Proposed INN: Deaxamethasone
INN or Proposed INN: cyclophosphamide
Hellenic Oncology Cooperative GroupNULLNot RecruitingFemale: yes
Male: yes
55Phase 1/2Greece
78EUCTR2006-006395-37-GB
(EUCTR)
06/09/200731/07/2007A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT)A randomised, multi-centre feasibility trial in AL Amyloidosis, comparing CTD with SCT in patients with low risk of Treatment Related Mortality and CTD with Mel-Dex in patients in whom SCT would not be considered appropriate as first line therapy - UK Amyloidosis Treatment Trial (UKATT) The medical condition to be investigated is systemic AL Amyloidosis, a disorder of protein folding in which normally soluble proteins are deposited as abnormal, insoluble fibrils that progressively disrupt tissue structure and impair function.
MedDRA version: 9.1;Level: LLT;Classification code 10002022;Term: Amyloidosis
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Cyclophosphamide
INN or Proposed INN: CYCLOPHOSPHAMIDE
Product Name: Dexamethasone
INN or Proposed INN: DEXAMETHASONE
Product Name: Dexamethasone
INN or Proposed INN: DEXAMETHASONE
Trade Name: Lenogastrim
Other descriptive name: GRANULOCYTE COLONY STIMULATING FACTOR
Product Name: Melphalan
INN or Proposed INN: MELPHALAN
Joint UCLH and UCL Biomedical Research UnitNULLNot Recruiting Female: yes
Male: yes
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
79NCT00520767
(ClinicalTrials.gov)
September 200724/8/2007Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition DiseaseA Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition DiseasePrimary Systemic Amyloidosis;Light Chain Deposition DiseaseDrug: bortezomib;Drug: dexamethasone;Drug: melphalan;Genetic: microarray analysis;Other: flow cytometry;Other: laboratory biomarker analysis;Procedure: quality-of-life assessmentBarbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)Active, not recruiting18 Years120 YearsAll35Phase 2United States
80NCT00458822
(ClinicalTrials.gov)
February 20079/4/2007Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic AmyloidosisRisk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmDrug: bortezomib;Drug: dexamethasoneMemorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Completed18 Years70 YearsAll40Phase 2United States
81NCT00477971
(ClinicalTrials.gov)
October 200523/5/2007Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic AmyloidosisPhase III Trial of Stem Cell Transplantation Compared to Parenteral Melphalan and Oral Dexamethasone in the Treatment of Primary Systemic Amyloidosis (AL)Multiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantationMayo ClinicNational Cancer Institute (NCI)Completed18 YearsN/AAll89Phase 3United States
82NCT00091260
(ClinicalTrials.gov)
January 20047/9/2004CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic AmyloidosisA Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL AmyloidosisMultiple MyelomaDrug: dexamethasone;Drug: lenalidomideVaishali SanchorawalaCelgene CorporationCompleted18 YearsN/AAll82Phase 2United States
83NCT00064337
(ClinicalTrials.gov)
January 20048/7/2003S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic AmyloidosisS0115, A Phase II Trial Evaluating Modified High Dose Melphalan (100 mg/m) And Autologous Peripheral Blood Stem Cell Supported Transplant (SCT) For High Risk Patients With Multiple Myeloma And/Or Light Chain Amyloidosis (AL Amyloidosis) (A BMT Study)Multiple Myeloma;Plasma Cell MyelomaBiological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantationSouthwest Oncology GroupNational Cancer Institute (NCI)Completed18 Years120 YearsAll104Phase 2United States
84NCT01527032
(ClinicalTrials.gov)
September 200228/7/2011Risk-adapted Therapy for Primary Systemic (AL) AmyloidosisRisk-adapted Therapy for AL AmyloidosisAmyloidosisDrug: melphalan, thalidomide and dexamethasoneFDA Office of Orphan Products DevelopmentNULLCompletedPhase 2NULL
85NCT00089167
(ClinicalTrials.gov)
May 20024/8/2004Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic AmyloidosisRisk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic AmyloidosisMultiple Myeloma and Plasma Cell NeoplasmBiological: filgrastim;Drug: dexamethasone;Drug: melphalan;Drug: thalidomideMemorial Sloan Kettering Cancer Center.National Cancer Institute (NCI)Completed18 YearsN/ABothPhase 2United States
86NCT00344526
(ClinicalTrials.gov)
January 200022/6/2006Intensive Versus Conventional Treatment in Patients With Primary AmyloidosisAutologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .Primary Systemic Amyloidosis (AL)Drug: Melphalan;Drug: Dexamethasone;Procedure: Autologous stem cell transplantationUniversity Hospital, LimogesMinistry of Health, FranceCompleted18 Years70 YearsBoth100Phase 3France
87NCT00002849
(ClinicalTrials.gov)
November 19961/11/1999S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic AmyloidosisPhase II Study of Dexamethasone/Alpha-Interferon in AL AmyloidosisMultiple MyelomaBiological: recombinant interferon alfa;Drug: dexamethasoneSouthwest Oncology GroupNational Cancer Institute (NCI);Cancer and Leukemia Group BCompleted18 YearsN/ABoth93Phase 2United States

46. Malignant rheumatoid arthritis


Clinical trials : 4,356 Drugs : 2,567 - (DrugBank : 415) / Drug target genes : 192 - Drug target pathways : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02666443
(ClinicalTrials.gov)
September 201624/1/2016Low Dose Dexamethasone in Supraclavicular BlocksLow Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control StudyRheumatoid Arthritis;Osteoarthritis;Nerve Entrapment;Ligament InjuryDrug: Control intervention (no dexamethasone);Drug: Peri-neural Dexamethasone 1 mg;Drug: Intravenous Dexamethasone 1 mgUniversity of CalgaryNULLRecruiting18 Years80 YearsBoth306N/ACanada
2EUCTR2009-017051-10-NL
(EUCTR)
13/07/201025/05/2010Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritisMetabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.
MedDRA version: 12.0;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up
Trade Name: Dexamethason
Product Name: dexamethason
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
3NCT00244153
(ClinicalTrials.gov)
June 200425/10/2005Intraarticular Opioids Vs Glucocorticosteroids in GonarthritisIntraarticular Application of Opioids Versus Glucocorticosteroids Versus Placebo in Rheumatoid ArthritisRheumatic DiseaseDrug: intraarticular morphine;Drug: intraarticular dexamethasoneCharite University, Berlin, GermanyNULLRecruiting19 YearsN/ABoth120Phase 1/Phase 2Germany

331. Idiopathic multicentric castleman disease


Clinical trials : 33 Drugs : 41 - (DrugBank : 21) / Drug target genes : 22 - Drug target pathways : 123
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03982771
(ClinicalTrials.gov)
January 1, 20193/5/2019BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)Bortezomib, Cyclophosphamide and Dexamethasone (BCD) in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) : a Prospective, Single-center, Single-arm, Phase-II Pilot TrialIdiopathic Multicentric Castleman's DiseaseDrug: Bortezomib;Drug: Cyclophosphamide;Drug: DexamethasonPeking Union Medical College HospitalNULLRecruiting18 YearsN/AAll30Phase 2China