DREAMM-11, Part 2: Japanese phase I trial of belantamab mafodotin combination therapies in relapsed/refractory multiple myeloma.

ABSTRACT: DREAMM-11 (NCT03828292) was a Phase 1, open-label, dose-escalation study of belantamab mafodotin in Japanese patients with relapsed/refractory multiple myeloma (RRMM). In Part 1, belantamab mafodotin monotherapy (2.5 or 3.4 mg/kg every 3 weeks) was tolerated and demonstrated clinical activity and a manageable safety profile. Part 2 investigated the tolerability, safety, clinical activity and pharmacokinetics of belantamab mafodotin (2.5 mg/kg on Day [D]1 of each 21-day cycle) plus bortezomib and dexamethasone (Arm A; N = 3) or belantamab mafodotin (2.5 mg/kg on D1 of the first 28-day cycle; 1.9 mg/kg on D1 of subsequent cycles) plus pomalidomide and dexamethasone (Arm B; N = 4) in Japanese patients with RRMM and ≥ 1 prior line of therapy. No dose-limiting toxicities were reported in Arm A;

SUBMITTER: Sunami K 

PROVIDER: S-EPMC11782446 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature