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NCT04162210 · ClinicalTrials.gov record · last posted 2026-07-01

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Study acronym: DREAMM-3
StatusActive, Not Recruiting
PhasePhase 3
Started2020-04-02
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from the ClinicalTrials.gov record
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

Protocol amendment history 1 change detected by DataLookout

2026-07-02
Trial sites expanded: 102 → 136 locations
Trial Details
NCT Number NCT04162210
Lead Sponsor GlaxoSmithKline
Conditions Multiple Myeloma
Enrollment 325 participants
Start Date 2020-04-02
Primary Completion 2022-09-12 (estimated)
Study Completion 2027-03-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-01