drugset / Trial / NCT07614360
Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to assess safety, efficacy and pharmacokinetic (PK) parameters with alternative dosing schedules of belantamab mafodotin in combination with bortezomib and dexamethasone compared to the approved dosing regimen in participants with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of therapy. The study will further characterize the risk of ocular toxicity and impact on efficacy measures and PK evaluations using alternative and approved dosing regimens.
Timeline
- Start
- 2026-08-03
- Primary completion
- 2029-02-28
- Completion
- 2031-02-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belantamab mafodotin | Monoclonal antibody | — | — |
| Background | Bortezomib | Small molecule | — | — |
| Background | Dexamethasone | Small molecule | — | — |