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 to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
- First Posted Date
- 2017-10-25
- Last Posted Date
- 2019-09-06
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 66
- Registration Number
- NCT03320707
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2017-10-19
- Last Posted Date
- 2024-06-17
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 156
- Registration Number
- NCT03314181
- Locations
- 🇦🇺
Eastern Health /ID# 165850, Box Hill, Victoria, Australia
🇨🇦Cross Cancer Institute /ID# 203114, Edmonton, Alberta, Canada
🇯🇵Kameda General Hospital /ID# 225246, Kamogawa-shi, Chiba, Japan
A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2017-09-25
- Last Posted Date
- 2024-07-05
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 75
- Registration Number
- NCT03290950
- Locations
- 🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant
- Conditions
- Interventions
- First Posted Date
- 2017-09-20
- Last Posted Date
- 2023-12-12
- Lead Sponsor
- International Myeloma Foundation
- Target Recruit Count
- 87
- Registration Number
- NCT03289299
- Locations
- 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸Levine Cancer Institute, Charlotte, North Carolina, United States
Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis
- Conditions
- Interventions
- First Posted Date
- 2017-09-14
- Last Posted Date
- 2024-12-12
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 21
- Registration Number
- NCT03283917
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2017-08-01
- Last Posted Date
- 2024-02-20
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 42
- Registration Number
- NCT03236428
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Pacific Cancer Care, Monterey, California, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2017-08-01
- Last Posted Date
- 2024-05-29
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 213
- Registration Number
- NCT03234972
- Locations
- 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇨🇳Peking Union Medical College Hospital, Beijing, China
🇨🇳Peking University First Hospital, Beijing, China
A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)
- Conditions
- Interventions
- First Posted Date
- 2017-07-14
- Last Posted Date
- 2024-04-25
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 220
- Registration Number
- NCT03217812
- Locations
- 🇭🇰
Queen Mary Hospital University of Hong Kong, Hong Kong, Hong Kong
🇰🇷Ulsan University Hospital, Ulsan, Korea, Republic of
🇲🇾Hospital Ampang, Ampang, Malaysia
Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)
- Conditions
- Interventions
- First Posted Date
- 2017-07-02
- Last Posted Date
- 2018-07-26
- Lead Sponsor
- M.D. Anderson Cancer Center
- Registration Number
- NCT03207542
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
- Conditions
- Interventions
- First Posted Date
- 2017-06-28
- Last Posted Date
- 2024-10-26
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 416
- Registration Number
- NCT03201965
- Locations
- 🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸University of Pennsylvania Medical Center, Philadelphia, Pennsylvania, United States
🇺🇸Cleveland Clinic, Cleveland, Ohio, United States
Drug Development Updates
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