Daratumumab

Generic Name: Daratumumab

Brand Names: Darzalex, Darzalex Faspro

Drug Type: Biotech

Chemical Formula: -

CAS Number: 945721-28-8

Unique Ingredient Identifier: 4Z63YK6E0E

Background: Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab. It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.
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Indication: Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma. It is available as a combination product with hyaluronidase for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs.

Associated Conditions: Multiple Myeloma (MM), Primary Amyloidosis, Refractory Multiple Myeloma, Relapsed Multiple Myeloma

Associated Therapies: -

Clinical Trials

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: VELCADE (Bortezomib)
Drug: Daratumumab
Drug: Dexamethasone

First Posted Date: 2014-05-12

Last Posted Date: 2024-03-13

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 498

Registration Number: NCT02136134

A Study of Daratumumab in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab

First Posted Date: 2014-04-17

Last Posted Date: 2016-09-26

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 9

Registration Number: NCT02116569

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

Phase 3

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Dexamethasone
Drug: Lenalidomide

First Posted Date: 2014-03-03

Last Posted Date: 2024-11-05

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 569

Registration Number: NCT02076009

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

Phase 2

Completed

Conditions: Microsatellite Stable Colorectal Cancer
Mismatch Repair Proficient Colorectal Cancer
Microsatellite Unstable Colorectal Cancer
Mismatch Repair Deficient Colorectal Cancer

Interventions: Drug: Ipilimumab
Drug: Nivolumab
Drug: Daratumumab
Drug: BMS-986016
Drug: Cobimetinib

First Posted Date: 2014-02-11

Last Posted Date: 2024-11-19

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 385

Registration Number: NCT02060188

Locations: 🇺🇸
Local Institution - 0028, Gilbert, Arizona, United States
🇺🇸
Local Institution - 0004, Los Angeles, California, United States
🇺🇸
Local Institution - 0036, Boston, Massachusetts, United States

and more 29 locations

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Velcade
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Melphalan
Drug: Thalidomide
Drug: Diphenhydramine
Drug: Prednisone
Drug: Acetaminophen
Drug: Carfilzomib
Drug: Montelukast
Drug: Lenalidomide

First Posted Date: 2013-12-03

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 240

Registration Number: NCT01998971

Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Pomalidomide
Drug: Dexamethasone
Drug: Daratumumab

First Posted Date: 2013-09-19

Last Posted Date: 2023-05-16

Lead Sponsor: Celgene

Target Recruit Count: 186

Registration Number: NCT01946477

Locations: 🇺🇸
Local Institution - 109, Los Angeles, California, United States
🇺🇸
Local Institution - 101, Hackensack, New Jersey, United States
🇺🇸
CR Wood Cancer Center, Glens Falls, New York, United States

and more 46 locations

Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Pomalidomide
Drug: Carfilzomib
Drug: dexamethasone
Drug: Daratumumab

First Posted Date: 2012-08-15

Last Posted Date: 2024-11-19

Lead Sponsor: University of Chicago

Target Recruit Count: 101

Registration Number: NCT01665794

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇨🇦
University Health Network - Princess Margaret Cancer Center, Toronto, Ontario, Canada
🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

and more 2 locations

Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib

Phase 2

Active, not recruiting

Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Drug: Dexamethasone
Drug: Cyclophosphamide
Biological: Daratumumab
Drug: Ixazomib Citrate
Other: Laboratory Biomarker Analysis

First Posted Date: 2011-08-12

Last Posted Date: 2024-06-13

Lead Sponsor: Mayo Clinic

Target Recruit Count: 165

Registration Number: NCT01415882

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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