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Daratumumab IV
Daratumumab is a monoclonal antibody that binds to CD38 on the surface of multiple myeloma cells, triggering their destruction through multiple immune mechanisms.
Daratumumab is a monoclonal antibody that binds to CD38 on the surface of multiple myeloma cells, triggering their destruction through multiple immune mechanisms. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.
At a glance
| Generic name | Daratumumab IV |
|---|---|
| Also known as | JNJ-54767414 |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | CD38-targeting monoclonal antibody |
| Target | CD38 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Daratumumab targets CD38, a cell surface antigen highly expressed on multiple myeloma cells. Upon binding, it induces cell death through antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). This multi-modal mechanism of action makes it effective in eliminating myeloma cells and overcoming some resistance mechanisms.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Light chain myeloma
Common side effects
- Infusion-related reactions
- Fatigue
- Nausea
- Thrombocytopenia
- Anemia
- Upper respiratory tract infection
- Pneumonia
Key clinical trials
- Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma (PHASE2)
- Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse (PHASE2)
- Subcutaneous Daratumumab, Once Weekly Carfilzomib, and Dexamethasone (DKd) in Patients With High-Risk Smoldering Multiple Myeloma (PHASE2)
- A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant (PHASE2, PHASE3)
- A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma (PHASE2)
- A Study to Determine Dose, Safety, Tolerability and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Subjects With Multiple Myeloma (PHASE1, PHASE2)
- A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma (PHASE1)
- A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |