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
- -
Daratumumab in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma and Severe Renal Impairment
- Conditions
- Interventions
- First Posted Date
- 2016-11-30
- Last Posted Date
- 2022-05-31
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Target Recruit Count
- 22
- Registration Number
- NCT02977494
- Locations
- 🇩🇪
Katholische Karl-Leisner Klinikum Goch, Goch, Germany
🇩🇪Charité Universitätsmedizin BerlinCampus Benjamin Franklin, Berlin, Germany
🇩🇪Asklepios Klinik Altona, Hamburg, Germany
Cyclophosphamide-Bortezomib-Dexamethasone (CyBorD) With Daratumumab (DARA)
- Conditions
- Interventions
- First Posted Date
- 2016-11-04
- Last Posted Date
- 2018-03-29
- Lead Sponsor
- National University of Ireland, Galway, Ireland
- Target Recruit Count
- 18
- Registration Number
- NCT02955810
- Locations
- 🇮🇪
Galway University Hospital, Galway, Ireland
A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2016-11-01
- Last Posted Date
- 2021-10-08
- Lead Sponsor
- Janssen Scientific Affairs, LLC
- Target Recruit Count
- 101
- Registration Number
- NCT02951819
A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type
- First Posted Date
- 2016-10-07
- Last Posted Date
- 2021-01-14
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 32
- Registration Number
- NCT02927925
- Locations
- 🇨🇳
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
🇨🇳Beijing Cancer Hospital, Beijing, China
🇨🇳Sun Yat-Sen University Cancer Center, Guangzhou, China
Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2016-08-22
- Last Posted Date
- 2023-07-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 224
- Registration Number
- NCT02874742
Dose Escalation Study of JNJ-54767414 (Daratumumab) in Chinese Participants With Relapsed or Refractory Multiple Myeloma Who Failed at Least 2 Prior Lines of Systemic Therapy
- First Posted Date
- 2016-08-02
- Last Posted Date
- 2020-11-16
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 50
- Registration Number
- NCT02852837
Daratumumab for the Treatment of Patients With AL Amyloidosis
- First Posted Date
- 2016-07-21
- Last Posted Date
- 2021-05-07
- Lead Sponsor
- Boston Medical Center
- Target Recruit Count
- 22
- Registration Number
- NCT02841033
- Locations
- 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
Daratumumab Therapy for Patients With Refractory or Relapsed AL Amyloidosis
- First Posted Date
- 2016-06-28
- Last Posted Date
- 2021-07-09
- Lead Sponsor
- University Hospital, Limoges
- Target Recruit Count
- 40
- Registration Number
- NCT02816476
- Locations
- 🇫🇷
CHU d'Angers, Angers, France
🇫🇷CHU de Limoges, Limoges, France
🇫🇷APHP - Necker, Paris, France
A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2016-06-21
- Last Posted Date
- 2023-02-21
- Lead Sponsor
- Celgene
- Target Recruit Count
- 37
- Registration Number
- NCT02807454
- Locations
- 🇺🇸
UCLA Division of Hematology Oncology, Los Angeles, California, United States
🇨🇦Local Institution - 103, Saint John, New Brunswick, Canada
🇨🇦Princess Margaret Cancer Centre, Toronto, Ontario, Canada
A Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome
- Conditions
- Interventions
- First Posted Date
- 2016-06-21
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- Syros Pharmaceuticals
- Target Recruit Count
- 155
- Registration Number
- NCT02807558
- Locations
- 🇫🇷
CHU Amiens, Amiens, France
🇫🇷Centre Hospitalier de la Côte basque, Bayonne, France
🇫🇷Centre Hospitalier Universitiaire Hopital Avicenne, Bobigny, France
Drug Development Updates
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