NOTE
🌱 created from: belantamab_mafodotin
dreamm-8
- from dreamm-7
Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma
Information
- Design: Phase 3, open-label, randomized, controlled, multi-center
- Number of patients: 302
- Patients characteristics: Lenalidomide-exposed patients who had relapsed or refractory multiple myeloma after at least one line of therapy
- Agent: Belantamab mafodotin, pomalidomide, and dexamethasone (BPd) vs pomalidomide, bortezomib, and dexamethasone (PVd)
- Treatment line: Second-line therapy or later
- Trial Name or NCT Number: DREAMM-8 (NCT04484623, EudraCT 2018-004354-21)
Comparison of two groups
| Endpoint | BPd | PVd |
|---|---|---|
| Progression-Free Survival at 12 months | 71% (95% CI, 63 to 78) | 51% (95% CI, 42 to 60) |
| Hazard Ratio for Disease Progression or Death | 0.52 (95% CI, 0.37 to 0.73); P<0.001 | - |
| Response Rate (Partial Response or Better) | 77% (95% CI, 70 to 84) | 72% (95% CI, 64 to 79) |
| Complete Response or Better | 40% (95% CI, 32 to 48) | 16% (95% CI, 11 to 23) |
Other findings
- Grade 3 or higher adverse events occurred in 94% of patients in the BPd group and 76% of those in the PVd group
- Ocular events occurred in 89% of patients who received BPd (grade 3 or 4 in 43%) and 30% of those who received PVd (grade 3 or 4 in 2%)
- Ocular events led to treatment discontinuation in 9% of patients in the BPd group and in no patients in the PVd group
Summary In this phase 3 trial, the combination of belantamab mafodotin, pomalidomide, and dexamethasone (BPd) significantly improved progression-free survival and response rates compared to pomalidomide, bortezomib, and dexamethasone (PVd) in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. However, BPd was associated with more frequent ocular events, which were manageable with dose modifications.