Daratumumab
- Generic Name
- Daratumumab
- Brand Names
- Darzalex, Darzalex Faspro
- Drug Type
- Biotech
- Chemical Formula
- -
- 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.
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- 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
- Associated Therapies
- -
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma
- First Posted Date
- 2020-02-13
- Last Posted Date
- 2024-06-14
- Lead Sponsor
- University of Miami
- Target Recruit Count
- 306
- Registration Number
- NCT04268498
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸Moffitt Cancer Center, Tampa, Florida, United States
Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab
- First Posted Date
- 2020-02-11
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Janssen Research & Development, LLC
- Registration Number
- NCT04264884
Daratumumab Plus Gemcitabine, Dexamethasone, Cisplatin in pt R/R CD38+ PTCL-NOS, AITL and TFH
- First Posted Date
- 2020-01-31
- Last Posted Date
- 2022-08-02
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Target Recruit Count
- 8
- Registration Number
- NCT04251065
- Locations
- 🇮🇹
Trieste - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia, Trieste, Italy
🇮🇹Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia, Meldola, Italy
🇮🇹ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia, Milano, Italy
Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2020-01-29
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 494
- Registration Number
- NCT04246047
- Locations
- 🇬🇧
GSK Investigational Site, Sutton, United Kingdom
Phase II Study of Daratumumab Pre-Mobilization and Post-ASCT in Multiple Myeloma
- First Posted Date
- 2020-01-18
- Last Posted Date
- 2022-04-21
- Lead Sponsor
- Wake Forest University Health Sciences
- Registration Number
- NCT04230031
- Locations
- 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study
- Conditions
- Interventions
- First Posted Date
- 2020-01-18
- Last Posted Date
- 2024-08-23
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 11
- Registration Number
- NCT04230304
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
Frailty Score-guided Dosing of Lenalidomide, Dexamethasone and Daratumumab Induction Therapy
- Conditions
- Interventions
- First Posted Date
- 2020-01-10
- Last Posted Date
- 2022-12-08
- Lead Sponsor
- Attaya Suvannasankha
- Registration Number
- NCT04223661
- Locations
- 🇺🇸
VA Roudebush Medical Center, Indianapolis, Indiana, United States
A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2019-12-02
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 419
- Registration Number
- NCT04181827
- Locations
- 🇺🇸
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Mayo Clinic Cancer Center-Scottsdale, Phoenix, Arizona, United States
Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM
- Conditions
- Interventions
- First Posted Date
- 2019-11-25
- Last Posted Date
- 2024-04-16
- Lead Sponsor
- Andrew Yee, MD
- Target Recruit Count
- 43
- Registration Number
- NCT04176718
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Daratumumab Combined With Bortezomib, Cyclophosphamide and Dexamethasone for the Treatment of Multiple Myeloma Patients Presenting With Extramedullary Disease
- Conditions
- Interventions
- First Posted Date
- 2019-11-18
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Stichting European Myeloma Network
- Target Recruit Count
- 41
- Registration Number
- NCT04166565
- Locations
- 🇬🇷
Anticancer Hospital of Thessaloniki, Thessaloníki, Greece
🇮🇹University of Bologna, Bologna, Italy
🇮🇹Univerity of Turin, Torino, Italy
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.