Clinical Trial

Study of Alternative and Approved Dosing Regimens of Belantamab Mafodotin, Bortezomib, and Dexamethasone (BVd) in Participants With Relapsed/Refractory Multiple Myeloma

Study acronym: DREAMM-16
Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 1 change
notable Enrollment increased: 120 -> 150 participants 2026-06-25
Trial Details
NCT Number NCT07614360
Lead Sponsor GlaxoSmithKline
Conditions Multiple Myeloma
Enrollment 150 participants
Start Date 2026-08-03
Primary Completion 2029-02-28 (estimated)
Study Completion 2031-02-11 (estimated)
Updated on ClinicalTrials.gov 2026-06-24