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
Teclistamab-Daratumumab and Talquestamab-Daratumumab in Newly Diagnosed High-risk Multiple Myeloma
- Conditions
- High-Risk de Novo Multiple Myeloma
- Interventions
- First Posted Date
- 2023-05-09
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- PETHEMA Foundation
- Target Recruit Count
- 30
- Registration Number
- NCT05849610
- Locations
- 🇪🇸
Hospital Germans Trials i Pujol, Badalona, Spain
🇪🇸Hospital Clinic i Provincial de Barcelona, Barcelona, Spain
🇪🇸Hospital Doce de Octubre, Madrid, Spain
Daratumumab-containing Induction Effects on Stem Cells Mobilization, colLection and Engraftment in Newly Diagnosed Multiple MyelomA Patients.
- Conditions
- Multiple MyelomaAutologous Stem Cell TransplantationLeukapheresisDaratumumab
- Interventions
- First Posted Date
- 2023-04-28
- Last Posted Date
- 2023-05-01
- Target Recruit Count
- 188
- Registration Number
- NCT05835726
- Locations
- 🇮🇹
Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome, Italy
Efficacy of Daratumumab to Overcome Platelet Transfusion Refractoriness in Patients with Aplastic Anemia
- Conditions
- Aplastic AnemiaPlatelet Transfusion Refractoriness
- Interventions
- First Posted Date
- 2023-04-27
- Last Posted Date
- 2025-01-03
- Target Recruit Count
- 10
- Registration Number
- NCT05832216
- Locations
- 🇨🇳
Regenerative Medicine Center, Tianjin, Tianjin, China
Daratumumab in STK11 Mutated NSCLC
- Conditions
- Non-small Cell Lung Cancer With STK11/LKB1 Mutation
- Interventions
- Drug: Pre-Intervention MedicationDrug: Post-Intervention Medication
- First Posted Date
- 2023-04-10
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- NYU Langone Health
- Target Recruit Count
- 14
- Registration Number
- NCT05807048
- Locations
- 🇺🇸
NYU Langone Health, New York, New York, United States
Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis
- Conditions
- Immunoglobulin Light-chain Amyloidosis
- Interventions
- First Posted Date
- 2023-03-20
- Last Posted Date
- 2023-03-20
- Lead Sponsor
- Air Force Military Medical University, China
- Target Recruit Count
- 116
- Registration Number
- NCT05776940
Escalation of Doses of Daratumumab in Combination With Chemotherapy (Idarubicin and Cytarabine) in Patients of 60 Years Old or More With Adverse Risk Acute Myeloblastic Leukemia (AML) (DARALAM)
- Conditions
- Adult Patients With Adverse Risk Acute Myeloblastic Leukemia
- Interventions
- First Posted Date
- 2023-03-01
- Last Posted Date
- 2024-04-18
- Lead Sponsor
- Nantes University Hospital
- Target Recruit Count
- 12
- Registration Number
- NCT05749276
Efficacy of Anti-CD20 Ab Associated With Anti-CD38 in the Childhood Multidrug Dependent and Resistant Nephrotic Syndrome
- Conditions
- Nephrotic Syndrome
- Interventions
- First Posted Date
- 2023-01-30
- Last Posted Date
- 2023-10-31
- Lead Sponsor
- Istituto Giannina Gaslini
- Target Recruit Count
- 20
- Registration Number
- NCT05704400
- Locations
- 🇮🇹
IRCCS G. Gaslini, Genova, Italy
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-01-25
- Last Posted Date
- 2024-10-23
- Lead Sponsor
- University of Heidelberg Medical Center
- Target Recruit Count
- 130
- Registration Number
- NCT05695508
- Locations
- 🇩🇪
Charité University Medicin Berlin, Berlin, Germany
🇩🇪Clinic Chemnitz gGmbH, Chemnitz, Germany
🇩🇪University Clinic Technical University Dresden, Dresden, Germany
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects
- Conditions
- Multiple Myeloma
- Interventions
- First Posted Date
- 2023-01-10
- Last Posted Date
- 2024-06-28
- Lead Sponsor
- Shanghai Henlius Biotech
- Target Recruit Count
- 172
- Registration Number
- NCT05679258
- Locations
- 🇨🇳
Beijing Hospital, Beijing, Beijing, China
🇨🇳Sir Run Run Hospital, Nanjing Medical University, Nanjing, Jiangsu, China
Daratumumab in Primary Antiphospholipid Syndrome
- First Posted Date
- 2023-01-05
- Last Posted Date
- 2024-11-29
- Target Recruit Count
- 22
- Registration Number
- NCT05671757
- Locations
- 🇺🇸
NYU Langone, New York, New York, United States
🇺🇸Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸Mayo Clinic Rochester, Rochester, Minnesota, United States
Drug Development Updates
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