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 Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2022-09-23
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 1590
- Registration Number
- NCT05552222
- Locations
- 🇨🇭
Kantonsspital St Gallen, St. Gallen, Switzerland
🇧🇷Liga Norte Riograndense Contra O Cancer, Natal, Brazil
🇧🇷Complexo Hospitalar de Niteroi, Niteroi, Brazil
Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2022-09-02
- Last Posted Date
- 2022-09-02
- Lead Sponsor
- PETHEMA Foundation
- Target Recruit Count
- 140
- Registration Number
- NCT05527340
- Locations
- 🇪🇸
Hospital Universitario de Canarias, La Laguna, Spain
🇪🇸Hospital Universitario 12 de Octubre, Madrid, Spain
🇪🇸Clínica Universidad de Navarra, Pamplona, Spain
Home Based Daratumumab Administration for Patients With Multiple Myeloma
- Conditions
- Plasma Cell Myeloma
- Interventions
- Other: Questionnaire AdministrationOther: Quality-of-Life AssessmentOther: Interview
- First Posted Date
- 2022-08-23
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- Thomas Jefferson University
- Target Recruit Count
- 20
- Registration Number
- NCT05511428
- Locations
- 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial
- Conditions
- ISS Stage III Plasma Cell MyelomaMultiple Myeloma
- Interventions
- Procedure: Bone Marrow Aspiration and BiopsyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyProcedure: Multigated Acquisition ScanProcedure: Biospecimen CollectionProcedure: EchocardiographyProcedure: Chest Radiography
- First Posted Date
- 2022-08-11
- Last Posted Date
- 2025-01-29
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 75
- Registration Number
- NCT05497804
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic, Jacksonville, Florida, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE)
- Conditions
- AL AmyloidosisLight Chain (AL) AmyloidosisSystemic Light Chain Disease
- Interventions
- Device: Cyclin D1 gene (CCDN1) /immunoglobulin heavy chain (IGH) fluorescence in situ hybridization (FISH) assay
- First Posted Date
- 2022-08-03
- Last Posted Date
- 2025-03-06
- Lead Sponsor
- Alfred Chung, MD
- Target Recruit Count
- 46
- Registration Number
- NCT05486481
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2022-07-13
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 810
- Registration Number
- NCT05455320
- Locations
- 🇯🇵
Chiba Cancer Center, Chiba, Japan
🇪🇸Hosp Univ Hm Sanchinarro, Madrid, Spain
🇪🇸Hosp Virgen de La Victoria, Malaga, Spain
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
- Conditions
- AL Amyloidosis
- Interventions
- First Posted Date
- 2022-07-11
- Last Posted Date
- 2024-06-28
- Lead Sponsor
- Rajshekhar Chakraborty, MD
- Target Recruit Count
- 53
- Registration Number
- NCT05451771
- Locations
- 🇺🇸
New York Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York, United States
🇺🇸Mayo Clinic Rochester, Rochester, Minnesota, United States
🇺🇸Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
A Study of Daratumumab
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2022-06-29
- Last Posted Date
- 2025-04-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 500
- Registration Number
- NCT05438043
- Locations
- 🇺🇸
University of Miami Sylvester Cancer Center, Miami, Florida, United States
🇺🇸Barnes-jewish Hospital, Saint Louis, Missouri, United States
🇧🇪ZNA Stuivenberg, Antwerpen, Belgium
COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2022-06-28
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- University of Alabama at Birmingham
- Target Recruit Count
- 80
- Registration Number
- NCT05434689
- Locations
- 🇺🇸
Duke University, Durham, North Carolina, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Ohio State University Medical College, Columbus, Ohio, United States
Study of Combination POM, BTZ, Low-Dose DEX, and DARA (PVD-DARA) in Patients With RRMM
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2022-06-07
- Last Posted Date
- 2023-01-27
- Lead Sponsor
- Alliance Foundation Trials, LLC.
- Registration Number
- NCT05408026
Drug Development Updates
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