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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

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
First Posted Date
2011-08-12
Last Posted Date
2025-02-13
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

Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
Other: Methylprednisolone
Other: Dexamethasone
First Posted Date
2007-12-17
Last Posted Date
2018-04-27
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
104
Registration Number
NCT00574288
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