The ongoing phase 3 DREAMM-7 trial will compare the safety and efficacy of belamaf plus bortezomib and dexamethasone (BVd) with daratumumab plus bortezomib and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM). Researchers presented the current status of DREAMM-7 at the 2021 British Society for Haematology annual meeting.
Belantamab mafodotin (belamaf) is an antibody-drug conjugate targeting B-cell maturation antigen (BCMA). In the phase 2 DREAMM-2 study, belamaf showed a good safety profile and durable response in patients with RRMM who were heavily pretreated.
Single-agent belamaf had an overall response rate of 32% in the study. Triple combination regimens are the standard of care for RRMM. A phase 1/2 study (DREAMM-6) of BVd has demonstrated an acceptable safety profile. The DREAMM-7 study aims to determine the effectiveness and safety of BVd compared with DVd in patients with RRMM.
DREAMM-7 includes patients who have received at least 1 prior line of therapy. The trial aims to randomize 478 patients 1:1 to each treatment arm. Progression free survival (PFS) is the primary endpoint, measured as time from randomization to disease progression or death.
The trial has secondary endpoints of minimal residual disease negativity, overall response rate, overall survival, and pharmacokinetics.
As of the time of the presentation, the study was enrolling patients in 19 countries, with 259 patients randomized.
Disclosure: This research was supported by GlaxoSmithKline. Please see the original reference for a full list of disclosures.
Rifkin R, Boyd K, Grosicki S, et al. DREAMM-7: A phase III study of the efficacy and safety of belantamab mafodotin with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma. Poster presented at: 2021 British Society for Haematology annual meeting; April 25-28, 2021; virtual.