Phase II Study of Different Doses and Schedules of Belantamab Mafodotin for Treating Triple-Class Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating different doses and schedules of belantamab mafodotin, a targeted therapy combining a monoclonal antibody and chemotherapy drug, for patients with triple-class refractory or recurrent multiple myeloma. This phase II trial aims to find if alternative dosing can reduce side effects like eye toxicity while effectively treating this condition. The study also explores treatment responses, safety, and survival outcomes in these patients. Participants are randomly assigned to one of two groups. One group receives a low dose of belantamab mafodotin intravenously every 6 weeks, while the other group starts with a dose every 3 weeks, then switches to every 6 weeks if tolerated. Both groups undergo imaging scans such as CT, MRI, or PETCT before and during the study if tumors are present. Bone marrow samples and blood tests are collected at screening and throughout the trial. Participants are followed closely with assessments including eye exams, imaging, bone marrow biopsies, and blood tests to monitor treatment effects and side effects. After finishing treatment, participants return for follow-up visits every 12 weeks for up to 5 years. Researchers measure outcomes like eye toxicity rates, overall response to treatment, disease progression, survival, and minimal residual disease negativity to assess the impact of these dosing strategies.

Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma