NOTE
🌱 created from: belantamab_mafodotin
dreamm-7
- also look at dreamm-8 PVd
Belantamab Mafodotin plus Bortezomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Information
- Design: Phase 3, open-label, randomized, controlled, multi-center
- Number of patients: 494
- Patients characteristics: Patients who had progression of multiple myeloma after at least one line of therapy
- Agent: Belantamab mafodotin, bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd)
- Treatment line: Second-line therapy or later
- Trial Name or NCT Number: DREAMM-7 (NCT04246047, EudraCT 2018-003993-29)
Comparison of two groups
| Endpoint | BVd | DVd |
|---|---|---|
| Progression-Free Survival | 36.6 months (95% CI, 28.4 to not reached) | 13.4 months (95% CI, 11.1 to 17.5) |
| Hazard Ratio for Disease Progression or Death | 0.41 (95% CI, 0.31 to 0.53); P<0.001 | - |
| Overall Survival at 18 months | 84% | 73% |
| Complete Response or Better plus MRD-Negative Status | 25% | 10% |
Other findings
- Grade 3 or higher adverse events occurred in 95% of patients in the BVd group and 78% of those in the DVd group
- Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%)
- Most ocular events were managed with dose modifications, and events of worsening visual acuity mostly resolved
Summary In this phase 3 trial, the combination of belantamab mafodotin, bortezomib, and dexamethasone (BVd) significantly improved progression-free survival compared to daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma after at least one line of therapy. However, BVd was associated with more frequent grade 3 or higher adverse events, including ocular events.