28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details


臨床試験数 : 261 薬物数 : 286 - (DrugBank : 81) / 標的遺伝子数 : 66 - 標的パスウェイ数 : 177

  
27 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2021-002639-48-ES
(EUCTR)
08/03/202228/12/2021A Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) AmyloidosisA Phase 2, Multicohort Study of Daratumumab-Based Therapies in Participants with Amyloid Light Chain (AL) Amyloidosis - Aquarius Amyloid Light Chain Amyloidosis
MedDRA version: 23.0;Level: LLT;Classification code 10083938;Term: Amyloid light-chain amyloidosis;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: DAZARLEX
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
Product Code: JNJ-54767414
INN or Proposed INN: Daratumumab
Other descriptive name: HuMax-CD38, 3003-005
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 2France;United States;Greece;Canada;Spain;Netherlands;Germany;United Kingdom;Italy
2NCT04895917
(ClinicalTrials.gov)
June 23, 202110/5/2021Daratumumab and Pomalidomide in Previously Treated Patients With AL AmyloidosisA Multi-center Open Label Phase II Study of Daratumumab and Pomalidomide in Previously Treated Patients With AL Amyloidosis.AL AmyloidosisDrug: daratumumab and pomalidomideIRCCS Policlinico S. MatteoNULLRecruiting18 Years99 YearsAll40Phase 2Italy
3NCT04270175
(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
4EUCTR2019-001962-13-IT
(EUCTR)
13/01/202121/10/2020Daratumumab and Pomalidomide in previously treated patients with AL amyloidosisA multi-center open label phase II study of daratumumab and pomalidomide in previously treated patients with AL amyloidosis - DarP-AL 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: Imnovid
Product Name: Pomalidomide
Product Code: [Pomalidomide]
INN or Proposed INN: pomalidomide
Product Name: Daratumumab
Product Code: [Daratumumab]
INN or Proposed INN: DARATUMUMAB
Trade Name: Imnovid
Product Name: Pomalidomide
Product Code: [Pomalidomide]
INN or Proposed INN: Pomalidomide
Trade Name: Imnovid
Product Name: Pomalidomide
Product Code: [Pomalidomide]
INN or Proposed INN: pomalidomide
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Italy
5NCT04304144
(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: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: DaratumumabCaelum BiosciencesNULLActive, not recruiting18 YearsN/AAll25Phase 2United States
6EUCTR2018-004333-33-FR
(EUCTR)
23/01/202002/12/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
7EUCTR2018-004333-33-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
8EUCTR2018-004333-33-NL
(EUCTR)
24/07/201908/07/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Darzalex
Product Name: Daratumumab
Product Code: JNJ-54767414
INN or Proposed INN: DARATUMUMAB
Trade Name: Velcade
Product Name: Bortezomib
Product Code: 26866138
INN or Proposed INN: BORTEZOMIB
Product Name: Daratumumab co-formulated with recombinant human hyaluronidase (rHuPH20)
INN or Proposed INN: DARATUMUMAB
Other descriptive name: HUMAX-CD38
INN or Proposed INN: Recombinant human hyaluronidase PH20
Other descriptive name: PEGYLATED RECOMBINANT HUMAN HYALURONIDASE PH20
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
9EUCTR2018-004333-33-GR
(EUCTR)
08/07/201905/06/2019Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosisPhase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis Patients with newly diagnosed stage 3B AL amyloidosis
MedDRA version: 20.0;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
European Myeloma NetworkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2France;Greece;Netherlands;Italy
10EUCTR2016-001737-27-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
11EUCTR2016-001737-27-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 3Sweden;Korea, Republic of;China;Japan;Germany;Netherlands;Denmark;Australia;Romania;Brazil;Belgium;Poland;Canada;Mexico;Hungary;France;United Kingdom;Italy;Israel;Turkey;Spain;Greece;United States
12EUCTR2016-001737-27-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
13JPRN-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 3Japan, Asia except Japan, North America, Europe
14EUCTR2016-001737-27-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
15EUCTR2016-001737-27-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
16EUCTR2016-001737-27-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
17EUCTR2016-001737-27-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
18EUCTR2016-001737-27-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
19NCT03283917
(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;Takeda PharmaceuticalRecruiting18 YearsN/AAll20Phase 1United States
20EUCTR2016-001737-27-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
21EUCTR2016-001737-27-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
22EUCTR2016-001737-27-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 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
23EUCTR2016-000287-42-IT
(EUCTR)
18/10/201705/01/2021A Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis in patients not in VGPR or Better - AMYDARA A Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis in patients not in VGPR or Better - AMYDARA AL amyloidosis
MedDRA version: 20.0;Level: HLGT;Classification code 10035227;Term: Plasma cell neoplasms;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04]
Product Name: HuMax-CD38
Product Code: NA
INN or Proposed INN: Daratumumab
CHU DE LIMOGESNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Italy
24NCT03201965
(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 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
25NCT02841033
(ClinicalTrials.gov)
March 20, 201714/6/2016Daratumumab for the Treatment of Patients With AL AmyloidosisA Phase I-II Trial of Daratumumab for the Treatment of Patients With AL AmyloidosisAL AmyloidosisDrug: daratumumabBoston Medical CenterJanssen PharmaceuticalsCompleted18 YearsN/AAll25Phase 1/Phase 2United States
26NCT02816476
(ClinicalTrials.gov)
September 201622/6/2016Daratumumab Therapy for Patients With Refractory or Relapsed AL AmyloidosisA Multicentre Open Label Phase II Study of Daratumumab in AL Amyloidosis Patients Not in VGPR or BetterAmyloidosisDrug: DaratumumabUniversity Hospital, LimogesNULLCompleted18 YearsN/AAll40Phase 2France;Italy
27EUCTR2016-000287-42-FR
(EUCTR)
18/05/201608/06/2016Amyloidosis Patients traitmentA Multicentre Open label Phase II study of Daratumumab in AL AmyloidosisPatients not in VGPR or Better - AMYDARA AL Amyloidosis
MedDRA version: 19.0;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
INN or Proposed INN: DARATUMUMAB
CHU de LimogesNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France