Clinical Trial

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments

Study acronym: DREAMM-20
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
The study consists of three parts: Part 1 The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent Unconjugated belantamab antibody in participants with refractory multiple myeloma (RRMM) who have received at least 3 prior therapies (4L+). Part 2 The primary purpose of this part is to evaluate the safety, tolerability, and clinical activity of different doses of unconjugated belantamab antibody in combination with a fixed dose of Belantamab mafodotin (delivered as separate drugs) in participants with RRMM who have received at least 3 prior therapies (4L+). Part 3: The Primary purpose of this part will evaluate the clinical activity of a selected dose of the unconjugated belantamab antibody in combination with the pomalidomide-dexamethasone (Pd) standard of care (SoC) backbone. The study will focus on participants with multiple myeloma who have undergone at least one prior line of therapy, including treatment with lenalidomide.
Protocol Amendment History 6 changes
critical Primary endpoint(s) modified 2026-07-11
notable Enrollment reduced: 152 -> 123 participants 2026-07-11
notable Trial sites expanded: 30 -> 36 locations 2026-07-11
notable Primary completion moved earlier: 2029-12-03 -> 2028-08-03 2026-07-11
minor Completion moved earlier: 2029-12-03 -> 2028-08-03 2026-07-11
notable Trial sites expanded: 27 -> 30 locations 2026-05-23
Trial Details
NCT Number NCT05714839
Lead Sponsor GlaxoSmithKline
Conditions Multiple Myeloma
Enrollment 123 participants
Start Date 2023-06-14
Primary Completion 2028-08-03 (estimated)
Study Completion 2028-08-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-10