At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of multiple myeloma per IMWG criteria
- ✓Previously treated with at least 1 prior line including lenalidomide-containing regimen with documented disease progression during or after most recent therapy
- ✓At least 1 aspect of measurable disease: urine M-protein ≥200 mg/24h, serum M-protein ≥0.5 g/dL, or involved FLC ≥10 mg/dL with abnormal ratio
- ✓Undergone ASCT or transplant ineligible; if prior ASCT, must be >100 days before first dose with no active infection
- ✕Active plasma cell leukemia, symptomatic amyloidosis, POEMS syndrome, or active polyneuropathy with organomegaly
- ✕Prior allogeneic stem cell transplant
- ✕Prior treatment with pomalidomide or intolerance to pomalidomide
- ✕Prior BCMA-targeted therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)
In Brief
A Phase 3 clinical trial evaluating Belantamab mafodotin, Pomalidomide, and 2 other interventions for Multiple Myeloma. Active but no longer recruiting, targeting 302 participants across 122 sites in 18 countries.
Signals
Detailed Summary
This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).
Study Details
Timeline
Arms & Interventions
Interventions
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
Immunomodulatory drug (IMiD) will be administered.
Synthetic glucocorticoid with anti-tumor activity will be administered.
Proteasome Inhibitor will be administered.