DREAMM-6: Safety and tolerability of belantamab mafodotin in combination with bortezomib and dexamethasone in relapsed refractory multiple myeloma
What is the DREAMM-6 trial?
The DREAMM-6 trial studies belantamab mafodotin (Bela), a B-cell maturation antigen targeting immunoconjugate. Bela has demonstrated clinically meaningful, single-agent activity in patients with heavily pre-treated relapsed refractory multiple myeloma (RRMM) who are refractory to an immunomodulatory agent, a proteasome inhibitor, and for those who are refractory and/or intolerant to an anti-CD38 monoclonal antibody.
In this video:
Dr. Ajay Nooka (Emory University - Atlanta) explains this ongoing, two-part, two-arm, study. DREAMM-6 evaluates the safety, tolerability, and clinical activity of belantamab mafodotin in combination with bortezomib/dexamethasone (BorDex) and lenalidomide/dexamethasone in patients previously treated with one or more prior lines of therapy.
Part 1 (dose escalation) and Part 2 (dose expansion) evaluated belantamab mafodotin (2.5 and 3.4 mg/kg) administered as SINGLE (Day 1) or SPLIT dose (divided equally on Days 1 and 8) in combination with BorDex. As of February 6, 2020, 52 patients were enrolled: 6 patients were enrolled at 2.5 mg/kg single dose and 7 at 3.4 mg/kg single dosing in Part 1, and 45 patients in Part 2. No dose-limiting toxicities were observed. Corneal events (including keratopathy, blurred vision, and dry eye) and thrombocytopenia were the most frequently reported adverse events and were clinically manageable.
The multimodal mechanism of action and manageable safety profile make belantamab mafodotin a promising candidate for use in different RRMM combination regimens. In DREAMM-6, preliminary data demonstrate that the combination of belantamab mafodotin and BorDex has an acceptable safety profile, with no new safety signals identified.
Clinical trial information: NCT03544281
AJAY NOOKA, MD
Ajay Kumar Nooka, MD, MPH, FACP, is an Associate Professor of Hematology and Medical Oncology at Emory University School of Medicine and a part of the hematology care team at Winship Cancer Institute of Emory University. Dr. Nooka is board certified in Internal Medicine and specializes in hematology and medical oncology. As a network physician, he started practicing with Emory Healthcare in 2011. He also serves as director of the Winship Research Informatics Shared Resource.