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 to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)
- Interventions
- First Posted Date
- 2024-09-26
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Target Recruit Count
- 440
- Registration Number
- NCT06615479
- Locations
- 🇺🇸
Local Institution - 0071, Birmingham, Alabama, United States
🇺🇸UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States
🇺🇸Local Institution - 0130, Miami, Florida, United States
A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-08-29
- Last Posted Date
- 2025-04-28
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 40
- Registration Number
- NCT06577025
- Locations
- 🇪🇸
Hosp. Univ. 12 de Octubre, Madrid, Spain
🇺🇸City of Hope, Duarte, California, United States
🇺🇸University of California San Francisco, San Francisco, California, United States
Daratumumab for T Cell ALL With MRD-positive After Standard Chemotherapy
- First Posted Date
- 2024-08-26
- Last Posted Date
- 2024-11-05
- Target Recruit Count
- 20
- Registration Number
- NCT06570915
Biomarkers of AKI in Patients Receiving Daratumumab
- Conditions
- Multiple MyelomaAcute Kidney InjuryLight Chain Nephropathy
- Interventions
- First Posted Date
- 2024-08-12
- Last Posted Date
- 2025-02-05
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 20
- Registration Number
- NCT06549634
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-07-17
- Last Posted Date
- 2024-07-17
- Lead Sponsor
- North Estonia Medical Centre
- Target Recruit Count
- 50
- Registration Number
- NCT06505369
- Locations
- 🇳🇴
Oslo University Hospital, Oslo Myeloma Centre, Oslo, Norway
🇳🇴Stavanger University Hospital, Stavanger, Norway
🇩🇰Vejle hospital, Vejle, Denmark
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
- Conditions
- Multiple MyelomaLight Chain NephropathyAcute Kidney Injury
- Interventions
- Procedure: Plasma exchange
- First Posted Date
- 2024-07-03
- Last Posted Date
- 2024-07-03
- Lead Sponsor
- Brigham and Women's Hospital
- Target Recruit Count
- 450
- Registration Number
- NCT06483139
- Locations
- 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
A Phase III Study of Eque-cel in Subjects with Len-refractory RRMM (FUMANBA-03)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-06-18
- Last Posted Date
- 2025-02-21
- Lead Sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Target Recruit Count
- 240
- Registration Number
- NCT06464991
- Locations
- 🇨🇳
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China
🇨🇳Beijing GoBoard Boren Hospital, Beijing, China
🇨🇳Fu Xing Hospital, Capital Medical University, Beijing, China
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-05-14
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Kite, A Gilead Company
- Target Recruit Count
- 450
- Registration Number
- NCT06413498
- Locations
- 🇪🇸
Hospital Universitario 12 de Octubre, Madrid, Spain
🇪🇸Clinica Universidad de Navarra, Pamplona, Spain
🇺🇸Winship Cancer Institute, Atlanta, Georgia, United States
Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection
- Conditions
- Newly DiagnosedHigh RiskMRDMultiple Myeloma
- Interventions
- Drug: VRD for first-cycle induction therapy
- First Posted Date
- 2024-05-10
- Last Posted Date
- 2024-05-10
- Lead Sponsor
- The First Affiliated Hospital of Soochow University
- Target Recruit Count
- 45
- Registration Number
- NCT06409702
Darzalex Faspro (Daratumumab and Hyaluronidase-fihj) Before Standard Desensitization and Allogeneic Peripheral Blood Stem Cell Transplantation in Adult Patients at High-risk for Primary Graft Failure Secondary to Donor Specific Antibodies
- Conditions
- Bone Marrow Transplant RejectionMyelodysplastic Syndromes (MDS)Aplastic AnemiaHodgkin LymphomaAcute Myeloid Leukemia (AML)Non Hodgkin LymphomaMyelofibrosisAcute Lymphoblastic Leukemia (ALL), AdultHematologic MalignancyMultiple Myeloma
- Interventions
- Device: JH-DSA Semi-Quant Screen and Response Score
- First Posted Date
- 2024-05-03
- Last Posted Date
- 2024-08-28
- Target Recruit Count
- 8
- Registration Number
- NCT06398457
- Locations
- 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Drug Development Updates
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