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
Japan Expansion Cohort: 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
- 2025-05-09
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 24
- Registration Number
- NCT06868667
- Locations
- 🇯🇵
GSK Investigational Site, Yokohama, Japan
Subcutaneous Talquetamab in Elderly Patients With Multiple Myeloma in Early Relapse
- Conditions
- Multiple Myeloma in Relapse
- Interventions
- First Posted Date
- 2025-02-14
- Last Posted Date
- 2025-04-09
- Lead Sponsor
- Larysa Sanchez
- Target Recruit Count
- 23
- Registration Number
- NCT06827860
- Locations
- 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma
- Conditions
- Recurrent Multiple Myeloma
- Interventions
- Procedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Bone ScanProcedure: Chest RadiographyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2025-01-21
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 37
- Registration Number
- NCT06785415
- Locations
- 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
A Study of JNJ-79635322 in Combination With Daratumumab or Pomalidomide for Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2025-01-10
- Last Posted Date
- 2025-04-25
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 100
- Registration Number
- NCT06768489
- Locations
- 🇦🇺
Monash Medical Centre, Clayton, Australia
🇳🇱VU Medisch Centrum, Amsterdam, Netherlands
🇳🇱Universitair Medisch Centrum Groningen, Groningen, Netherlands
To Evaluate the Efficacy and Safety of QL2109 and DARZALEX FASPRO® in Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-12-19
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Qilu Pharmaceutical Co., Ltd.
- Target Recruit Count
- 284
- Registration Number
- NCT06742138
Risk Stratification and MRD-driven Maintenance for MM After ASCT
- First Posted Date
- 2024-11-20
- Last Posted Date
- 2024-11-25
- Lead Sponsor
- Peking University People's Hospital
- Target Recruit Count
- 100
- Registration Number
- NCT06697483
- Locations
- 🇨🇳
Fuxing Hospital, Beijing, Beijing, China
🇨🇳Peking Union Medical College Hospital, Beijing, Beijing, China
🇨🇳Peking University People's Hospital, Beijing, Beijing, China
A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)
- Conditions
- Multiple MyelomaNewly Diagnosed Multiple Myeloma
- Interventions
- First Posted Date
- 2024-11-07
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 520
- Registration Number
- NCT06679101
- Locations
- 🇨🇳
GSK Investigational Site, Kaohsiung, Taiwan
An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L
- Conditions
- Primary Plasma Cell Leukemia
- Interventions
- First Posted Date
- 2024-10-10
- Last Posted Date
- 2024-10-10
- Lead Sponsor
- Hellenic Society of Hematology
- Target Recruit Count
- 43
- Registration Number
- NCT06636552
- Locations
- 🇬🇷
1st Propaedeutic Department, "Laiko" General Hospital of Athens, Athens, Attica, Greece
🇬🇷Hematology Clinic, General Hospital of Athens "Evanggelismos", Athens, Attica, Greece
🇬🇷Hematology Department "Alexandra" General Hospital of Athens, Athens, Attica, Greece
Daratumumab Combined with Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)
- Conditions
- Light Chain (AL) Amyloidosis
- Interventions
- First Posted Date
- 2024-10-08
- Last Posted Date
- 2025-01-22
- Lead Sponsor
- Peking Union Medical College Hospital
- Target Recruit Count
- 36
- Registration Number
- NCT06629818
- Locations
- 🇨🇳
Peking Union Medical College Hospital, Beijing, --- Select One ---, China
SX-682 in Combination With Carfilzomib, Daratumumab-Hyaluronidase, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- Conditions
- Recurrent Multiple MyelomaRefractory Multiple Myeloma
- Interventions
- Drug: Cxcr1/2 Inhibitor SX-682Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: EchocardiographyProcedure: Positron Emission TomographyProcedure: Computed TomographyProcedure: Magnetic Resonance Imaging
- First Posted Date
- 2024-10-01
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Roswell Park Cancer Institute
- Target Recruit Count
- 15
- Registration Number
- NCT06622005
- Locations
- 🇺🇸
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.