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
Frontline T-cell Engager vs Autologous Stem Cell Transplant (ASCT) and Measurable Residual Disease (MRD)-Guided Sequential Intensification thERapy in Multiple Myeloma
- Conditions
- Multiple Myeloma, Newly DiagnosedMultiple Myeloma (MM)
- Interventions
- First Posted Date
- 2025-05-16
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- SCRI Development Innovations, LLC
- Target Recruit Count
- 100
- Registration Number
- NCT06974786
A Study to Assess Adverse Events and Change in Disease Activity of Oral ABBV-453 Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2025-05-01
- Last Posted Date
- 2025-05-18
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 130
- Registration Number
- NCT06953960
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
- Conditions
- Recurrent Multiple MyelomaRefractory Multiple Myeloma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: FDG-Positron Emission Tomography
- First Posted Date
- 2025-04-29
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 80
- Registration Number
- NCT06948084
A Study to Learn How Safe and How Well Linvoseltamab Works Compared to Standard Treatment in Adult Patients With Multiple Myeloma Who Are Not Eligible for Transplant
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2025-04-17
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- European Myeloma Network B.V.
- Target Recruit Count
- 1000
- Registration Number
- NCT06932562
Comparison of Elranatamab and Lenalidomide Versus Daratumumab and Lenalidomide as Post-transplant Maintenance Therapy in Patients With Newly Diagnosed Myeloma (ElMMA)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2025-04-17
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- Nantes University Hospital
- Target Recruit Count
- 176
- Registration Number
- NCT06931704
- Locations
- 🇫🇷
CHU Angers, Angers, France
🇫🇷CH Côte Basque, Bayonne, France
🇫🇷CHU Besançon, Besançon, France
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- Drug: HLX15-IV
- First Posted Date
- 2025-03-26
- Last Posted Date
- 2025-03-26
- Lead Sponsor
- Shanghai Henlius Biotech
- Target Recruit Count
- 386
- Registration Number
- NCT06895512
- Locations
- 🇨🇳
Zhongshan hospital, Shanghai, Shanghai, Shanghai, China
Anti-CD38 Antibody Treating Primary Immune Thrombocytopenia (ITP)
- First Posted Date
- 2025-03-25
- Last Posted Date
- 2025-03-25
- Target Recruit Count
- 30
- Registration Number
- NCT06838962
- Locations
- 🇨🇳
Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin, Tianjin, China
A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2025-03-24
- Last Posted Date
- 2025-04-24
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 440
- Registration Number
- NCT06892522
The Effect of Daratumumab in Patients with Monoclonal Gammopathy of Renal Significance (MGRS) in Finland
- Conditions
- Kidney FailureParaproteinemiasGlomerulonephritis
- Interventions
- First Posted Date
- 2025-03-21
- Last Posted Date
- 2025-03-21
- Lead Sponsor
- Helsinki University Central Hospital
- Target Recruit Count
- 30
- Registration Number
- NCT06889948
- Locations
- 🇫🇮
Helsinki University Hospital, Helsinki, Finland
China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2025-03-11
- Last Posted Date
- 2025-04-23
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 72
- Registration Number
- NCT06868654
- Locations
- 🇨🇳
GSK Investigational Site, Zhengzhou, China
Drug Development Updates
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