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 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
A Study of JNJ-54767414 (Daratumumab) in Combination With Lenalidomide and Dexamethasone in Japanese Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy and Autologous Stem Cell Transplantation
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2016-09-28
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Target Recruit Count
- 7
- Registration Number
- NCT02918331
Study Comparing Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (D-RVd) Versus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Subjects With Newly Diagnosed Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2016-08-22
- Last Posted Date
- 2025-02-04
- 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 Biomarker-Directed Phase 2 Trial of Tamibarotene (SY-1425) in Participants With Acute Myeloid Leukemia or Myelodysplastic Syndrome
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndrome
- 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
A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- 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 Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2016-05-16
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Celgene
- Target Recruit Count
- 466
- Registration Number
- NCT02773030
- Locations
- 🇺🇸
Local Institution - 101, Atlanta, Georgia, United States
🇺🇸Local Institution - 108, Hackensack, New Jersey, United States
🇺🇸Local Institution - 115, Boston, Massachusetts, United States
Study of Daratumumab in Combination With Dexamethasone in Resistant or Refractory Multiple Myeloma
- First Posted Date
- 2015-12-10
- Last Posted Date
- 2021-03-26
- Lead Sponsor
- University Hospital, Lille
- Target Recruit Count
- 64
- Registration Number
- NCT02626481
- Locations
- 🇧🇪
AZ ST Jan hematology department, Bruges, Belgium
🇧🇪Hematologie Laarbeeklaan, Brussel, Belgium
🇧🇪Jules Bordet Institute, Brussel, Belgium
Drug Development Updates
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