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Dara 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 | Dara 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 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). The IV formulation allows systemic delivery for treatment of hematologic malignancies.
Approved indications
- Multiple myeloma (newly diagnosed and relapsed/refractory)
- Light chain myeloma
Common side effects
- Infusion-related reactions
- Fatigue
- Nausea
- Diarrhea
- Anemia
- Thrombocytopenia
- Upper respiratory tract infection
Key clinical trials
- 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)
- 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)
- Rapid dFLC Response Predict CHR in AL Amyloidosis
- Selvigaltin With Standard of Care Treatment for the Treatment of Relapsed/Refractory Multiple Myeloma (PHASE1)
- Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma (PHASE1, PHASE2)
- Selinexor and Backbone Treatments of Multiple Myeloma Patients (PHASE1, PHASE2)
- Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex (PHASE3)
- An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dara IV CI brief — competitive landscape report
- Dara IV updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI