Actively Recruiting
Phase 1 Trial of Belantamab Mafodotin for Treating High-Risk Smoldering Multiple Myeloma with Dose Finding and Expansion Phases
Led by M.D. Anderson Cancer Center · Updated on 2026-06-11
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and recommended dose of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma, a condition involving abnormal plasma cells in the bone marrow. This phase 1, single-center, single-arm study includes a dose-finding part and a dose-expansion part with up to 30 patients. The main goal is to find the maximum tolerated dose or recommended phase 2 dose and assess overall response rates. Participants receive Belantamab Mafodotin through an intravenous infusion lasting 30 to 60 minutes on the first day of each 56-day treatment cycle, for six cycles. After determining the best dose during the initial phase, additional patients will be treated at this dose during the expansion phase. The study also explores immune and molecular profiles, drug effects, and resistance mechanisms. Throughout the study, participants will have regular assessments including blood tests, bone marrow biopsies, and imaging to monitor response and safety. Researchers will track overall response, progression-free survival, overall survival, and duration of response. The study includes safety monitoring and will last about one year from treatment start to completion.
CONDITIONS
Brief Title
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma
Research Team
A
Astrid Murga
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