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
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2022-02-25
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Stichting European Myeloma Network
- Target Recruit Count
- 750
- Registration Number
- NCT05257083
- Locations
- 🇺🇸
University of Arkansas, Little Rock, Arkansas, United States
🇺🇸City of Hope, Duarte, California, United States
🇺🇸UC San Diego Health Moores Cancer Center, San Diego, California, United States
A Study of Daratumumab-Based Therapies in Participants With Amyloid Light Chain (AL) Amyloidosis
- Conditions
- Amyloidosis
- Interventions
- First Posted Date
- 2022-02-22
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 150
- Registration Number
- NCT05250973
- Locations
- 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸Smilow Cancer Hospital/Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸Moffitt Cancer Center, Tampa, Florida, United States
A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
- First Posted Date
- 2022-02-17
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 18
- Registration Number
- NCT05243342
- Locations
- 🇳🇴
Oslo Universitetssykehus HF, Oslo, Norway
🇦🇺Royal Adelaide Hospital, Adelaide, South Australia, Australia
🇦🇺Alfred Hospital, Melbourne, Victoria, Australia
Evaluation of Maintenance With Bortezomib Plus Daratumumab (V-Dara) After Induction With Bortezomib, Melphalan, Prednisone Plus Daratumumab (VMP-Dara) in Newly Diagnosed Multiple Myeloma (MM) Patients Non-eligible for autoSCT
- Conditions
- Non-eligible for Autologous Stem Cell Transplantation (ASCT)Multiple Myeloma
- Interventions
- First Posted Date
- 2022-02-01
- Last Posted Date
- 2022-09-16
- Lead Sponsor
- PETHEMA Foundation
- Target Recruit Count
- 100
- Registration Number
- NCT05218603
- Locations
- 🇪🇸
Hospital Quirón Sagrado Corazón, Barcelona, Spain
🇪🇸Complejo Hospitalario Universitario de Gran Canaria Dr. Negrín, Las Palmas De Gran Canaria, Spain
🇪🇸Hospital Ruber Juan Bravo 39, Madrid, Spain
A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
- Conditions
- Relapsed Hematologic MalignancyRefractory Hematologic Malignancy
- Interventions
- First Posted Date
- 2022-01-25
- Last Posted Date
- 2023-08-15
- Lead Sponsor
- Epizyme, Inc.
- Registration Number
- NCT05205252
- Locations
- 🇺🇸
Central Care Cancer Center, Bolivar, Missouri, United States
🇺🇸California Cancer Associates For Research And Excellence, cCARE, Santa Fe, California, United States
🇺🇸Astera Cancer Center, East Brunswick, New Jersey, United States
FT576 in Subjects With Multiple Myeloma
- Conditions
- Multiple MyelomaMyeloma
- Interventions
- Drug: FT576 (Allogenic CAR NK cells with BCMA expression)
- First Posted Date
- 2022-01-10
- Last Posted Date
- 2024-08-02
- Lead Sponsor
- Fate Therapeutics
- Target Recruit Count
- 31
- Registration Number
- NCT05182073
- Locations
- 🇺🇸
Texas Oncology-Medical City Dallas, Dallas, Texas, United States
🇺🇸Indiana University, Indianapolis, Indiana, United States
🇺🇸Virginia Oncology Associates, Norfolk, Virginia, United States
A Study of TTI-622 in Combination With Daratumumab Hyaluronidase-fihj in People With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2021-12-01
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 7
- Registration Number
- NCT05139225
- Locations
- 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸Memorial Sloan Kettering Commack, Commack, New York, United States
A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2021-11-30
- Last Posted Date
- 2025-03-07
- Lead Sponsor
- Regeneron Pharmaceuticals
- Target Recruit Count
- 317
- Registration Number
- NCT05137054
- Locations
- 🇪🇸
Hospital Clínico Universitario de Santiago, Santiago, A Coruña, Spain
🇺🇸Scripps Clinic Torrey Pines, La Jolla, California, United States
🇺🇸Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
A Study to Access of Daratumumab Combined With VRD in the Treatment of Patients With Standard-risk Newly Diagnosed MM
- Conditions
- Newly Diagnosed Multiple Myeloma
- Interventions
- First Posted Date
- 2021-10-21
- Last Posted Date
- 2021-10-21
- Lead Sponsor
- The First Affiliated Hospital of Soochow University
- Target Recruit Count
- 76
- Registration Number
- NCT05088330
A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2021-10-19
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 587
- Registration Number
- NCT05083169
- Locations
- 🇸🇪
Skanes universitetssjukhus, Lund, Sweden
🇸🇪Norrlands Universitetssjukhus, Umea, Sweden
🇸🇪Akademiska Sjukhuset, Uppsala, Sweden
Drug Development Updates
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