drugset / Trial / NCT04975997
Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).
Timeline
- Start
- 2022-06-23
- Primary completion
- 2027-11-16
- Completion
- 2032-06-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Comparator | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |
| Comparator | Dexamethasone | Small molecule | 20 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Iberdomide | Small molecule | 1 mg | Oral |
| Subject | Iberdomide | Small molecule | 1.3 mg | Oral |
| Subject | Iberdomide | Small molecule | 1.6 mg | Oral |