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
Phase 2 Study Applying MRD Techniques for Participants With Previously Untreated Multiple Myeloma Treated With D-VRd Prior To and After High-dose Therapy Followed by ASCT - TAURUS
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-01-05
- Last Posted Date
- 2024-04-23
- Lead Sponsor
- Stichting European Myeloma Network
- Target Recruit Count
- 200
- Registration Number
- NCT06189833
- Locations
- 🇬🇷
St Savvas Cancer Hospital, Athens, Greece
🇩🇪Universitätsklinikum Hamburg - Eppendorf, Hamburg, Germany
🇦🇹Innsbruck Medical University, Innsbruck, Austria
FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2024-01-02
- Last Posted Date
- 2024-08-19
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Target Recruit Count
- 599
- Registration Number
- NCT06187441
- Locations
- 🇳🇱
NL-Amsterdam- UMC, Amsterdam, Netherlands
🇳🇱NL-Amsterdam-AmsterdamUMC, Amsterdam, Netherlands
🇳🇱Nij Smellinghe Ziekenhuis, Drachten, Netherlands
Fixed Duration vs Continuous Daratumumab in Transplant Ineligible Older Adults With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-12-27
- Last Posted Date
- 2025-05-13
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 559
- Registration Number
- NCT06182774
- Locations
- 🇨🇦
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
🇨🇦CHU de Quebec-Hopital l'Enfant-Jesus (HEJ), Quebec City, Quebec, Canada
🇨🇦BCCA - Kelowna, Kelowna, British Columbia, Canada
Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2023-12-13
- Last Posted Date
- 2025-03-14
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 70
- Registration Number
- NCT06169215
- Locations
- 🇺🇸
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States
🇺🇸UCI Health Laguna Hills, Laguna Hills, California, United States
🇺🇸UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction/Consolidation/Maintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple MyelomaExtramedullary Multiple MyelomaPrimary Plasma Cell Leukemia
- Interventions
- First Posted Date
- 2023-11-21
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Wuhan Union Hospital, China
- Target Recruit Count
- 54
- Registration Number
- NCT06140966
- Locations
- 🇨🇳
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
- Conditions
- Relapsed Multiple MyelomaMultiple MyelomaBlood CancerRelapsed Non-Hodgkin LymphomaRefractory Multiple MyelomaNHLRefractory Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2023-11-07
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- Indapta Therapeutics, INC.
- Target Recruit Count
- 128
- Registration Number
- NCT06119685
- Locations
- 🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸Valkyrie Clinical Trials, Los Angeles, California, United States
🇺🇸Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center, Lake Mary, Florida, United States
Teclistamab or Talquetamab in Combination with Daratumumab for High-Risk Smoldering Myeloma (REVIVE Study)
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-10-25
- Last Posted Date
- 2025-02-20
- Lead Sponsor
- Carl Ola Landgren, MD, PhD
- Target Recruit Count
- 50
- Registration Number
- NCT06100237
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
A Study of CyBorD (Cyclophosphamide, Bortezomib, Dexamethasone) Plus Daratumumab in People With Monoclonal Gammopathy of Renal Significance (MGRS)
- Conditions
- Multiple MyelomaMonoclonal Gammopathy of Renal Significance
- Interventions
- First Posted Date
- 2023-10-16
- Last Posted Date
- 2025-05-16
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 61
- Registration Number
- NCT06083922
- Locations
- 🇺🇸
Tufts Medical Center (Data Collection Only), Boston, Massachusetts, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
A Study Evaluating Safety, Tolerability, and Clinical Activity of Forimtamig-Based Treatment Combinations in Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Interventions
- First Posted Date
- 2023-09-26
- Last Posted Date
- 2025-05-07
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 316
- Registration Number
- NCT06055075
- Locations
- 🇦🇺
Princess Alexandra Hospital Woolloongabba, Woolloongabba, Queensland, Australia
🇦🇺Royal Adelaide Hospital, Adelaide, South Australia, Australia
🇨🇦Hamilton Health Sciences, Hamilton, Ontario, Canada
Daratumumab for Polyneuropathy Associated With MGUS
- Conditions
- Monoclonal Gammopathy of Undetermined SignificancePeripheral Neuropathy
- Interventions
- First Posted Date
- 2023-09-21
- Last Posted Date
- 2025-03-24
- Lead Sponsor
- Georgetown University
- Target Recruit Count
- 20
- Registration Number
- NCT06046287
- Locations
- 🇺🇸
Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia, United States
🇺🇸John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.