28. 全身性アミロイドーシス Systemic amyloidosis Clinical trials / Disease details
臨床試験数 : 267 / 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05486481 (ClinicalTrials.gov) | April 1, 2023 | 1/8/2022 | Venetoclax, 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 Disease | Drug: Venetoclax;Drug: Dexamethasone;Drug: Daratumumab | Sandy Wong, MD | Janssen Pharmaceuticals;AbbVie | Not yet recruiting | 18 Years | N/A | All | 78 | Phase 1/Phase 2 | United States |
| 2 | NCT05451771 (ClinicalTrials.gov) | October 26, 2022 | 6/7/2022 | Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis | An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis | AL Amyloidosis | Drug: 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 Dexamethasone | Rajshekhar Chakraborty, MD | Genentech, Inc. | Recruiting | 18 Years | N/A | All | 53 | Phase 1/Phase 2 | United States |
| 3 | JPRN-jRCT2031220037 | 20/06/2022 | 23/04/2022 | A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis | A 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 Christie | NULL | Recruiting | >= 18age old | Not applicable | Both | 16 | Phase 3 | Australia;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 |
| 4 | NCT05066607 (ClinicalTrials.gov) | February 11, 2022 | 24/8/2021 | Isatuximab Plus Pomalidomide and Dexamethasone Association for Patients With AL Amyloidosis Not in VGPR or Better After Any Previous Therapy | A 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 Therapy | AL Amyloidosis | Drug: Isatuximab | Intergroupe Francophone du Myelome | Sanofi;Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 46 | Phase 2 | France |
| 5 | NCT04984330 (ClinicalTrials.gov) | December 2021 | 29/7/2021 | Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease | Selinexor for Treatment of Light Chain Amyloidosis With Relapsed/Refractory Disease | Amyloid;Amyloidosis;AL Amyloidosis | Drug: Selinexor;Drug: Dexamethasone | Weill Medical College of Cornell University | Karyopharm Therapeutics Inc | Withdrawn | 18 Years | N/A | All | 0 | Early Phase 1 | United States |
| 6 | NCT04754945 (ClinicalTrials.gov) | April 28, 2021 | 9/2/2021 | Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis | Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy | AL Amyloidosis | Drug: Bortezomib;Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: Isatuximab | Emory University | Sanofi;National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 25 | Phase 1 | United States |
| 7 | NCT04270175 (ClinicalTrials.gov) | April 14, 2021 | 12/2/2020 | Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab | Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab | Amyloid;AL Amyloidosis;Refractory AL Amyloidosis | Drug: Daratumumab;Drug: Pomalidomide;Drug: Dexamethasone | Weill Medical College of Cornell University | Janssen Scientific Affairs, LLC | Recruiting | 18 Years | N/A | All | 21 | Phase 2 | United States |
| 8 | NCT04504825 (ClinicalTrials.gov) | February 2, 2021 | 20/7/2020 | A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen | Alexion | NULL | Recruiting | 18 Years | N/A | All | 124 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Switzerland;United Kingdom |
| 9 | NCT04512235 (ClinicalTrials.gov) | November 12, 2020 | 10/8/2020 | A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis | A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Other: Placebo;Drug: cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen | Alexion | NULL | Recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 10 | NCT04115956 (ClinicalTrials.gov) | August 6, 2020 | 29/8/2019 | A Clinical Study of Melphalan Flufenamide (Melflufen) and Dexamethasone for Patients With Immunoglobulin Light Chain (AL) Amyloidosis | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients With AL Amyloidosis Following at Least One Prior Line of Therapy | AL Amyloidosis | Drug: Melphalan-Flufenamide (Melflufen);Drug: Dexamethasone | Oncopeptides AB | PRA Health Sciences | Terminated | 18 Years | N/A | All | 6 | Phase 1/Phase 2 | United States;Czechia;France;Germany;Greece;Israel;Norway;Spain;United Kingdom;Italy;Poland |
| 11 | NCT04304144 (ClinicalTrials.gov) | March 18, 2020 | 28/2/2020 | A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis | AL Amyloidosis | Drug: CAEL-101;Drug: SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD);Drug: Daratumumab | Alexion Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States |
| 12 | EUCTR2018-002761-19-DE (EUCTR) | 06/03/2020 | 12/08/2019 | It 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 13 | EUCTR2018-002761-19-ES (EUCTR) | 05/02/2020 | 09/08/2019 | It 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | United States;France;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;United Kingdom;Italy | ||
| 14 | NCT04612582 (ClinicalTrials.gov) | January 1, 2020 | 15/6/2020 | Comparison of BTD and BCD Based Regimens in the Treatment of AL Amyloidosis | A 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 Amyloidosis | Drug: Thalidomide;Drug: Cyclophosphamide | Guangdong Provincial People's Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 70 | Phase 4 | China |
| 15 | EUCTR2018-002761-19-GR (EUCTR) | 03/12/2019 | 15/11/2019 | It 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | United States;France;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 16 | EUCTR2018-002761-19-NO (EUCTR) | 15/11/2019 | 01/08/2019 | It 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Germany;Norway;United Kingdom;Italy | ||
| 17 | EUCTR2018-002761-19-IT (EUCTR) | 25/10/2019 | 29/01/2021 | It is an early clinical trial to assess a new drug (Melflufen) when given together with a steroid (Dexamethasone) in the treatment of patients with a disease called the AL Amyloidosis. Patients should also have received treatment in the past for the disease. | An Open-Label, Phase 1/2 Study of Melflufen and Dexamethasone for Patients with AL Amyloidosis Following at Least One Prior Line of Therapy - 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 1;Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 18 | EUCTR2018-002761-19-PL (EUCTR) | 24/10/2019 | 07/08/2019 | It 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czechia;Czech Republic;Greece;Spain;Poland;Israel;Norway;Germany;United Kingdom;Italy | ||
| 19 | EUCTR2018-002761-19-CZ (EUCTR) | 21/10/2019 | 31/07/2019 | It 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 AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 46 | Phase 2 | France;United States;Czech Republic;Greece;Poland;Spain;Israel;Norway;Germany;Italy;United Kingdom | ||
| 20 | EUCTR2018-004333-33-IT (EUCTR) | 01/08/2019 | 28/04/2020 | Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis | Phase 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 Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;Greece;Netherlands;Italy | ||
| 21 | EUCTR2016-001737-27-GB (EUCTR) | 08/10/2018 | 11/01/2018 | A 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) Amyloidosis | A 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. | NULL | Authorised-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): no | United 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 | ||
| 22 | EUCTR2016-001737-27-PL (EUCTR) | 06/09/2018 | 16/07/2018 | A 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) Amyloidosis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United 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 | ||
| 23 | EUCTR2016-001737-27-DK (EUCTR) | 22/08/2018 | 04/06/2018 | A 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) Amyloidosis | A 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. | NULL | Authorised-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): no | United 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 | ||
| 24 | NCT03618537 (ClinicalTrials.gov) | August 2, 2018 | 2/8/2018 | Ixazomib Maintenance Study in Patients With AL Amyloidosis | Ixazomib Maintenance Following Initial Therapy in Patients With Immunoglobulin Light Chain (AL) Amyloidosis | AL Amyloidosis | Drug: Ixazomib;Drug: Dexamethasone | Memorial Sloan Kettering Cancer Center | Tufts Medical Center;Vanderbilt University Medical Center | Recruiting | 18 Years | N/A | All | 47 | Phase 2 | United States |
| 25 | JPRN-JapicCTI-183929 | 17/7/2018 | 13/04/2018 | A 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) Amyloidosis | A 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 | Amyloidosis | Intervention 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. | NULL | complete | 20 | BOTH | 370 | Phase 4 | Japan, Asia except Japan, North America, Europe | |
| 26 | EUCTR2016-001737-27-SE (EUCTR) | 07/05/2018 | 20/11/2017 | A 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) Amyloidosis | A 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. | NULL | Authorised-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): no | United 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 | ||
| 27 | EUCTR2016-001737-27-GR (EUCTR) | 16/04/2018 | 22/03/2018 | A 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) Amyloidosis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United 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 | ||
| 28 | EUCTR2016-001737-27-DE (EUCTR) | 16/04/2018 | 16/11/2017 | A 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) Amyloidosis | A 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. | NULL | Authorised-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): no | United 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 | ||
| 29 | NCT03130348 (ClinicalTrials.gov) | March 15, 2018 | 21/4/2017 | Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain Amyloidosis | Phase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain Amyloidosis | Amyloidosis;Immunoglobulin Light Chain Deposition | Drug: Bortezomib;Drug: Dexamethasone;Drug: Ibrutinib;Other: Laboratory Biomarker Analysis | Mayo Clinic | National Cancer Institute (NCI) | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 30 | EUCTR2016-001737-27-NL (EUCTR) | 15/03/2018 | 29/11/2017 | A 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) Amyloidosis | A 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. | NULL | Authorised-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): no | United 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 | ||
| 31 | EUCTR2016-001737-27-IT (EUCTR) | 01/03/2018 | 17/06/2021 | A 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) Amyloidosis | A 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 NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United 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 | ||
| 32 | NCT03283917 (ClinicalTrials.gov) | February 7, 2018 | 13/9/2017 | Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis | A Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis | Newly Diagnosed Primary Amyloidosis;Recurrent Primary Amyloidosis;Refractory Primary Amyloidosis | Biological: Daratumumab;Drug: Dexamethasone;Drug: Ixazomib | M.D. Anderson Cancer Center | Janssen Pharmaceuticals;Takeda | Recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 33 | EUCTR2016-001737-27-ES (EUCTR) | 06/02/2018 | 23/11/2017 | A 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) Amyloidosis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United 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 | ||
| 34 | EUCTR2016-001737-27-HU (EUCTR) | 25/01/2018 | 28/11/2017 | A 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) Amyloidosis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United 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 | ||
| 35 | EUCTR2016-001737-27-BE (EUCTR) | 16/01/2018 | 16/11/2017 | A 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) Amyloidosis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 370 | Phase 3 | United 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 | ||
| 36 | NCT03201965 (ClinicalTrials.gov) | October 5, 2017 | 27/6/2017 | A 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) Amyloidosis | A 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 | Amyloidosis | Drug: Cyclophosphamide;Drug: Bortezomib;Drug: Dexamethasone, 40 mg;Drug: Daratumumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 18 Years | N/A | All | 416 | Phase 3 | Canada;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 |
| 37 | ChiCTR-IPR-17012637 | 2017-10-01 | 2017-09-11 | Prospective 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 | Prospective 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 amyloidosis | Group 1:the combination regimen of bortezomib +thalidomide + dexamethasone (VTD);Group 2:the combination regimen of bortezomib + cyclophosphamide + dexamethasone (VCD); | Guangdong General Hospital | NULL | Pending | 18 | 75 | Both | Group 1:35;Group 2:35; | China | |
| 38 | NCT03252600 (ClinicalTrials.gov) | August 25, 2017 | 24/7/2017 | Lenalidomide, Dexamethasone, and Elotuzumab With or Without Cyclophosphamide in Treating Patients With Relapsed Primary Amyloidosis | A Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL Amyloidosis | Recurrent Primary Amyloidosis | Drug: Cyclophosphamide;Drug: Dexamethasone;Biological: Elotuzumab;Other: Laboratory Biomarker Analysis;Drug: Lenalidomide;Other: Pharmacological Study | Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI);Bristol-Myers Squibb;Multiple Myeloma Research Consortium | Active, not recruiting | 18 Years | N/A | All | 53 | Phase 2 | United States |
| 39 | NCT03236792 (ClinicalTrials.gov) | June 12, 2017 | 20/7/2017 | Ixazomib In Combination With Cyclophosphamide And Dexamethasone for Newly Diagnosed AL Amyloidosis | Phase 1/2 Study Of Ixazomib In Combination With Cyclophosphamide And Dexamethasone In Patients With Newly Diagnosed Immunoglobulin Light Chain AL Amyloidosis | AL Amyloidosis | Drug: Ixazomib;Drug: Cyclophosphamide;Drug: Dexamethasone | Icahn School of Medicine at Mount Sinai | Millennium Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 28 | Phase 1/Phase 2 | United States |
| 40 | NCT03000660 (ClinicalTrials.gov) | January 2017 | 12/12/2016 | Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis | A Phase I Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis | AL Amyloidosis | Drug: Venetoclax;Drug: Dexamethasone | Tufts Medical Center | NULL | Terminated | 18 Years | N/A | All | 3 | Phase 1 | United States |
| 41 | ChiCTR-IPR-16008422 | 2016-05-05 | 2016-05-08 | 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) | 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 University | NULL | Recruiting | 18 | 75 | Both | the first group:60;the second group:60; | China | |
| 42 | NCT02545907 (ClinicalTrials.gov) | October 2015 | 27/8/2015 | A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis | A Single Arm Open Labeled Multicentre Phase 1b Dose Escalation Study of Carfilzomib Taken in Combination With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis | Amyloidosis | Drug: Carfilzomib;Drug: Thalidomide;Drug: Dexamethasone | University College, London | NULL | Not yet recruiting | 18 Years | N/A | Both | 36 | Phase 1/Phase 2 | United Kingdom |
| 43 | NCT01807286 (ClinicalTrials.gov) | January 2014 | 6/3/2013 | Pomalidomide With Melphalan and Dexamethasone for Untreated Systemic AL Amyloidosis | A Phase I/II Clinical Trial of Pomalidomide With Melphalan and Dexamethasone in Patients With Newly Diagnosed Untreated Systemic AL Amyloidosis: Trial Stopped During Phase I | Myeloma | Drug: Pomalidomide;Drug: Melphalan;Drug: Dexamethasone;Behavioral: Questionnaires | M.D. Anderson Cancer Center | Celgene | Terminated | 18 Years | N/A | Both | 3 | Phase 1 | United States |
| 44 | EUCTR2010-022395-31-CZ (EUCTR) | 01/10/2013 | 17/07/2013 | 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. | 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 NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 45 | NCT01849783 (ClinicalTrials.gov) | April 4, 2013 | 6/5/2013 | Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma | Single Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy | Extramedullary Plasmacytoma;Isolated Plasmacytoma of Bone;Light Chain Deposition Disease;Primary Systemic Amyloidosis;Stage I Multiple Myeloma;Stage II Multiple Myeloma;Stage III Multiple Myeloma | Drug: dexamethasone;Drug: cisplatin;Drug: doxorubicin;Drug: cyclophosphamide;Drug: etoposide;Drug: bortezomib;Drug: thalidomide;Drug: melphalan;Procedure: autologous stem cell transplant | Yogesh Jethava | National Cancer Institute (NCI) | Active, not recruiting | 65 Years | 85 Years | All | 41 | Phase 2 | United States |
| 46 | NCT01728259 (ClinicalTrials.gov) | March 2013 | 13/11/2012 | First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD | Phase I Study of Pomalidomide, Bortezomib, and Dexamethasone (PVD) as First-Line Treatment of AL Amyloidosis or Light Chain Deposition Disease | Light Chain Deposition Disease;Primary Systemic Amyloidosis | Drug: pomalidomide;Drug: bortezomib;Drug: dexamethasone;Other: Laboratory Biomarker Analysis | Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | N/A | All | 36 | Phase 1 | United States;Canada;New Zealand |
| 47 | NCT01222260 (ClinicalTrials.gov) | January 2013 | 14/10/2010 | Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis | Phase II Study of the Combination of Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis | AL Amyloidosis | Drug: Bendamustine;Drug: Dexamethasone | Columbia University | Cephalon | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States |
| 48 | EUCTR2010-022395-31-DE (EUCTR) | 25/10/2012 | 18/10/2012 | Clinical trial of Melphalan and Dexamethasone versus Bortezomib, Melphalan and Dexamethasone 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 - 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 Network | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | France;Czech Republic;Greece;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 49 | EUCTR2010-022395-31-ES (EUCTR) | 13/06/2012 | 21/05/2012 | 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 | 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] - 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 NETWORK | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United Kingdom;Germany;Netherlands;Denmark;Norway;France;Spain;Italy;Greece;Sweden | ||
| 50 | NCT01570387 (ClinicalTrials.gov) | June 2012 | 27/2/2012 | A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis | A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis | AL Amyloidosis | Drug: Pomalidomide;Drug: Dexamethasone | Boston Medical Center | Celgene Corporation | Completed | 18 Years | N/A | All | 27 | Phase 1/Phase 2 | United States |
| 51 | EUCTR2010-021445-42-BE (EUCTR) | 10/05/2012 | 10/10/2011 | A 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 Foundation | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Belgium;Germany;Netherlands | ||
| 52 | EUCTR2010-021445-42-DE (EUCTR) | 09/05/2012 | 23/01/2012 | A study to investigated whether bortezomib is effective in patients with AL amyloidosis | A 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 Foundation | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Belgium;Netherlands;Germany | ||
| 53 | EUCTR2010-022395-31-GR (EUCTR) | 02/05/2012 | 02/04/2012 | N/A | N/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 Network | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | United Kingdom;Denmark;Spain;Italy;Greece;Sweden;Australia | |||
| 54 | EUCTR2011-001787-22-IT (EUCTR) | 02/05/2012 | 12/01/2012 | Treatment 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. MATTEO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
| 55 | NCT01510613 (ClinicalTrials.gov) | February 2012 | 11/1/2012 | Pomalidomide and Dexamethasone (PDex) in AL Amyloidosis | An Open-label, Phase II Study of Pomalidomide and Dexamethasone (PDex) for Previously Treated Patients With AL Amyloidosis. | Primary Amyloidosis of Light Chain Type | Drug: Pomalidomide and Dexamethasone | IRCCS Policlinico S. Matteo | NULL | Completed | 18 Years | N/A | All | 28 | Phase 2 | Italy |
| 56 | EUCTR2010-022395-31-DK (EUCTR) | 14/11/2011 | 09/06/2011 | 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 | 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 NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Czech Republic;Greece;Spain;Denmark;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 57 | JPRN-UMIN000006604 | 2011/11/01 | 24/10/2011 | 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. | 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 Hematology | NULL | Complete: follow-up complete | 20years-old | 65years-old | Male and Female | 21 | Phase 1,2 | Japan |
| 58 | EUCTR2010-021445-42-NL (EUCTR) | 31/08/2011 | 27/01/2011 | A study in which is investigated if the medicine bortezomib is effective in patients with AL amyloidosis | A 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 Foundation | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Belgium;Germany;Netherlands | ||
| 59 | EUCTR2010-022395-31-SE (EUCTR) | 10/06/2011 | 12/04/2011 | 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 | 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 NETWORK | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United Kingdom;Denmark;Spain;Italy;Greece;Sweden | ||
| 60 | NCT01273844 (ClinicalTrials.gov) | March 1, 2011 | 3/1/2011 | Study of Bortezomib +HSCT in Primary Systemic Amyloidosis (AL) | Study of the Combination of Bortezomib and Dexamethasone Followed by HSCT in AL | Amyloidosis | Drug: Bortezomib | Zhi-Hong Liu, M.D. | Soochow University;Nanjing Medical University | Completed | 18 Years | 65 Years | All | 21 | N/A | China |
| 61 | NCT01277016 (ClinicalTrials.gov) | January 2011 | 10/1/2011 | A Trial for 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 | Drug: BMDex | European Myeloma Network | NULL | Completed | 18 Years | N/A | All | 110 | Phase 3 | Italy |
| 62 | NCT01078454 (ClinicalTrials.gov) | November 2010 | 27/2/2010 | Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis | A 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 Transplantation | Light Chain Deposition Disease;Primary Systemic Amyloidosis | Drug: melphalan;Drug: dexamethasone;Drug: bortezomib | National Cancer Institute (NCI) | NULL | Completed | 18 Years | N/A | All | 11 | Phase 3 | United States |
| 63 | EUCTR2010-022395-31-IT (EUCTR) | 07/10/2010 | 01/12/2010 | 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 - ND | 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 - 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 NETWORK | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Italy;Sweden | ||
| 64 | NCT01194791 (ClinicalTrials.gov) | October 2010 | 26/7/2010 | Lendexal in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed | A Multicentric, Phase II Trial of Lenalidomide, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis (AL) Newly Diagnosed, Not Candidates for Hematopoietic Stem Cell Transplantation | Primary Systemic Amyloidosis | Drug: Lenalidomide;Drug: Cyclophosphamide;Drug: Dexamethasone | PETHEMA Foundation | NULL | Completed | 18 Years | N/A | All | 30 | Phase 2 | Spain |
| 65 | NCT01072773 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis | Phase II Study of Bortezomib, Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Light Chain Amyloidosis | Primary Systemic Amyloidosis | Drug: bortezomib;Drug: cyclophosphamide;Drug: dexamethasone | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 2 | Phase 2 | United States |
| 66 | NCT01083316 (ClinicalTrials.gov) | September 2009 | 2/11/2009 | Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation for Primary (AL) Amyloidosis | Phase II Trial of Induction Therapy With Bortezomib and Dexamethasone Followed by High-Dose Melphalan and Stem Cell Transplantation in Patients With AL Amyloidosis | Amyloidosis | Drug: Bortezomib;Drug: Dexamethasone;Drug: Melphalan | Boston Medical Center | Millennium Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 35 | Phase 2 | United States |
| 67 | NCT00883623 (ClinicalTrials.gov) | April 2009 | 15/4/2009 | A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis | A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis | Primary Amyloidosis | Drug: Lenalidomide | Heidelberg University | Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH | Completed | 18 Years | 74 Years | Both | 50 | Phase 2 | Germany |
| 68 | NCT00890552 (ClinicalTrials.gov) | April 2009 | 28/4/2009 | A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis | A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis | Leukemia;Amyloidosis | Drug: Lenalidomide;Drug: Melphalan;Drug: Dexamethasone | Stanford University | Celgene Corporation | Completed | 18 Years | N/A | All | 25 | N/A | United States |
| 69 | EUCTR2008-001405-41-DE (EUCTR) | 24/10/2008 | 28/08/2008 | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX | AL amyloidosis | Trade Name: Revlimid Other descriptive name: Lenalidomide Trade Name: Alkeran Product Code: L01AA03 Other descriptive name: melphalan Trade Name: Fortecortin Other descriptive name: dexamethasone | GMIHO mbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 70 | NCT00679367 (ClinicalTrials.gov) | May 2008 | 14/5/2008 | Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis | Multiple Myeloma | Drug: dexamethasone;Drug: lenalidomide;Drug: melphalan | Boston Medical Center | NULL | Completed | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 71 | EUCTR2007-006037-13-IT (EUCTR) | 21/02/2008 | 10/12/2007 | An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND | An 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. MATTEO | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 72 | NCT00607581 (ClinicalTrials.gov) | February 2008 | 22/1/2008 | Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis | An Open-label, Phase II Study of Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis | Amyloidosis | Drug: cyclophosphamide;Drug: lenalidomide;Drug: dexamethasone | IRCCS Policlinico S. Matteo | Celgene Corporation | Completed | 18 Years | N/A | Both | 21 | Phase 2 | Italy |
| 73 | NCT00981708 (ClinicalTrials.gov) | February 2008 | 19/9/2009 | Lenalidomide, 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 Amyloidosis | Amyloidosis | Drug: Lenalidomide, Dexamethasone and Cyclophosphamide | University of Athens | Hellenic Cooperative Oncology Group | Completed | 18 Years | N/A | All | 37 | Phase 1/Phase 2 | Greece |
| 74 | NCT01998503 (ClinicalTrials.gov) | December 2007 | 15/11/2013 | Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis | Induction Therapy With Bortezomib and Dexamethasone Followed by Autologous Stem Cell Transplantation Versus Autologous Stem Cell Transplantation Alone in the Treatment of AL Amyloidosis | Amyloidosis | Drug: Bortezomib;Drug: dexamethasone;Biological: filgrastim;Procedure: autologous hematopoietic stem cell transplantation (ASCT);Drug: Melphalan | Nanjing University School of Medicine | NULL | Completed | 18 Years | 65 Years | Both | 56 | Phase 3 | China |
| 75 | NCT00564889 (ClinicalTrials.gov) | December 2007 | 28/11/2007 | Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Drug: cyclophosphamide;Drug: dexamethasone;Drug: lenalidomide | Mayo Clinic | National Cancer Institute (NCI) | Completed | 18 Years | N/A | All | 35 | Phase 2 | United States |
| 76 | EUCTR2006-007082-36-GR (EUCTR) | 16/10/2007 | 18/07/2007 | A Phase I/II trial of lenalidomide combined with cyclophosphamide and intermediate dose dexamethasone in patients with primary (AL) systemic amyloidosis - CDR in amyloidosis | A 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 treatments | Trade 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 Group | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 1/2 | Greece | ||
| 77 | EUCTR2006-006395-37-GB (EUCTR) | 06/09/2007 | 31/07/2007 | 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) | 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 Unit | NULL | Not 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): no | United Kingdom | ||
| 78 | NCT00520767 (ClinicalTrials.gov) | September 2007 | 24/8/2007 | Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease | A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease | Primary Systemic Amyloidosis;Light Chain Deposition Disease | Drug: bortezomib;Drug: dexamethasone;Drug: melphalan;Genetic: microarray analysis;Other: flow cytometry;Other: laboratory biomarker analysis;Procedure: quality-of-life assessment | Barbara Ann Karmanos Cancer Institute | National Cancer Institute (NCI) | Active, not recruiting | 18 Years | 120 Years | All | 35 | Phase 2 | United States |
| 79 | NCT00458822 (ClinicalTrials.gov) | February 2007 | 9/4/2007 | Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis | Risk-Adapted Intravenous Melphalan With Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients With Systemic Light-Chain (AL) Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Drug: bortezomib;Drug: dexamethasone | Memorial Sloan Kettering Cancer Center | National Cancer Institute (NCI) | Completed | 18 Years | 70 Years | All | 40 | Phase 2 | United States |
| 80 | NCT00477971 (ClinicalTrials.gov) | October 2005 | 23/5/2007 | Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis | Phase 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 Neoplasm | Biological: filgrastim;Drug: dexamethasone;Drug: melphalan;Procedure: autologous hematopoietic stem cell transplantation | Mayo Clinic | National Cancer Institute (NCI) | Completed | 18 Years | N/A | All | 89 | Phase 3 | United States |
| 81 | NCT00091260 (ClinicalTrials.gov) | January 2004 | 7/9/2004 | CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis | A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis | Multiple Myeloma | Drug: dexamethasone;Drug: lenalidomide | Vaishali Sanchorawala | Celgene Corporation | Completed | 18 Years | N/A | All | 82 | Phase 2 | United States |
| 82 | NCT00064337 (ClinicalTrials.gov) | January 2004 | 8/7/2003 | S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis | S0115, 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 Myeloma | Biological: filgrastim;Drug: cyclophosphamide;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide;Procedure: peripheral blood stem cell transplantation | Southwest Oncology Group | National Cancer Institute (NCI) | Completed | 18 Years | 120 Years | All | 104 | Phase 2 | United States |
| 83 | NCT01527032 (ClinicalTrials.gov) | September 2002 | 28/7/2011 | Risk-adapted Therapy for Primary Systemic (AL) Amyloidosis | Risk-adapted Therapy for AL Amyloidosis | Amyloidosis | Drug: melphalan, thalidomide and dexamethasone | FDA Office of Orphan Products Development | NULL | Completed | Phase 2 | NULL | ||||
| 84 | NCT00089167 (ClinicalTrials.gov) | May 2002 | 4/8/2004 | Melphalan, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed, Previously Untreated Primary Systemic Amyloidosis | Risk Adapted Intravenous Melphalan and Adjuvant Thalidomide and Dexamethasone for Untreated Patients With Primary Systemic Amyloidosis | Multiple Myeloma and Plasma Cell Neoplasm | Biological: filgrastim;Drug: dexamethasone;Drug: melphalan;Drug: thalidomide | Memorial Sloan Kettering Cancer Center. | National Cancer Institute (NCI) | Completed | 18 Years | N/A | Both | Phase 2 | United States | |
| 85 | NCT00344526 (ClinicalTrials.gov) | January 2000 | 22/6/2006 | Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis | Autologous 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 transplantation | University Hospital, Limoges | Ministry of Health, France | Completed | 18 Years | 70 Years | Both | 100 | Phase 3 | France |
| 86 | NCT00002849 (ClinicalTrials.gov) | November 1996 | 1/11/1999 | S9628 Dexamethasone Plus Interferon Alfa in Treating Patients With Primary Systemic Amyloidosis | Phase II Study of Dexamethasone/Alpha-Interferon in AL Amyloidosis | Multiple Myeloma | Biological: recombinant interferon alfa;Drug: dexamethasone | Southwest Oncology Group | National Cancer Institute (NCI);Cancer and Leukemia Group B | Completed | 18 Years | N/A | Both | 93 | Phase 2 | United States |