Phase 12 Study Evaluating Belantamab Alone and With Other Treatments for Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and clinical activity of an unconjugated belantamab antibody alone and in combination with other treatments for people with refractory multiple myeloma RRMM. This study includes participants who have had several prior therapies, including a proteasome inhibitor, lenalidomide, and an anti-CD38 monoclonal antibody. The trial has three parts focusing on different combinations and dosages to better understand how these treatments work in this condition. Participants will receive one of several treatments depending on the study part in Part 1, they receive escalating doses of the unconjugated belantamab antibody alone in Part 2, the antibody is combined with a fixed dose of belantamab mafodotin, given as separate drugs and in Part 3, the antibody is combined with a pomalidomide-dexamethasone standard care backbone. Treatment in Parts 1 and 2 continues until disease progression, after which participants may opt to receive belantamab mafodotin alone. During the study, participants are monitored for adverse events and dose-limiting toxicities, as well as changes in laboratory and vital signs parameters. Researchers also track ocular events using a specific visual acuity scale. The study measures treatment responses, including overall response rates and very good partial response rates, along with drug levels in the blood. Participants are followed for up to 52 months to assess treatment effects and safety under medical supervision throughout the trial.

A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments