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Daratumumab

Generic Name
Daratumumab
Brand Names
Darzalex, Darzalex Faspro
Drug Type
Biotech
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.

Daratumumab was granted FDA approval on 16 November 2015. It is approved for the treatment of multiple myeloma as monotherapy or combination therapy and light chain (AL) amyloidosis in combination with other drugs.

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

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

Phase 3
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2014-05-12
Last Posted Date
2025-04-29
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
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
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2014-03-03
Last Posted Date
2025-05-01
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
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

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
First Posted Date
2013-09-19
Last Posted Date
2025-03-10
Lead Sponsor
Celgene
Target Recruit Count
186
Registration Number
NCT01946477
Locations
🇺🇸

Local Institution - 128, Lubbock, Texas, United States

🇺🇸

Local Institution - 106, Spokane, Washington, United States

🇨🇦

Local Institution - 113, Calgary, Alberta, Canada

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
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

Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

Phase 1
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2012-06-08
Last Posted Date
2025-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
45
Registration Number
NCT01615029
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