DREAMM-2 — Belantamab Mafodotin (GSK2857916) in Relapsed/Refractory Multiple Myeloma (DREAMM-2)

Phase 2 · 2020 · Multiple Myeloma

Design

Randomized, open-label two-dose trial (2.5 vs 3.4 mg/kg) of single-agent belantamab mafodotin.

Population

Relapsed/refractory multiple myeloma after at least three lines including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

Primary Endpoint

overall response rate (ORR)

Key Result

ORR 31% at the 2.5 mg/kg dose with durable responses; keratopathy was the characteristic dose-limiting toxicity.

Guideline Impact

Granted accelerated approval 2020 (later withdrawn in the US after DREAMM-3); informs BCMA ADC development