Comparing Lower Versus Standard Doses of Belantamab Mafodotin With Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma.
brief summary
This study is testing whether a lower dose of belantamab mafodotin used together with pomalidomide and dexamethasone can provide similar effectiveness with fewer side effects compared with the standard dose in patients with relapsed or refractory multiple myeloma. Participants will be randomly assigned to receive either a reduced dose or a standard dose of belantamab mafodotin in combination with pomalidomide and dexamethasone. The study will evaluate treatment response, side effects, and minimal residual disease (MRD), which is a measure of the number of myeloma cells that remain after treatment. The goal is to determine whether treatment can be optimized while maintaining disease control and reducing treatment-related toxicity.
detailed description
Multiple myeloma remains an incurable plasma cell malignancy despite substantial advances in treatment. Although currently available therapies have improved patient outcomes, most patients eventually experience disease relapse and require additional treatment options. Therefore, there remains a need to optimize therapeutic strategies that can provide durable disease control while minimizing treatment-related toxicity.
Belantamab mafodotin is a B-cell maturation antigen (BCMA)-targeted antibody-drug conjugate that has demonstrated clinically meaningful anti-myeloma activity in patients with relapsed or refractory multiple myeloma. Combination treatment with belantamab mafodotin, pomalidomide, and dexamethasone represents a promising therapeutic approach for this patient population. However, treatment-related adverse events, particularly ocular toxicities, may require dose modifications or treatment interruptions and can affect the overall treatment experience.
The REBEL study has been designed to investigate whether a reduced-dose strategy of belantamab mafodotin can maintain clinical benefit while improving tolerability. The study will also evaluate the use of minimal residual disease (MRD) assessment as part of a treatment-guidance approach. MRD has emerged as an important measure of treatment response and may provide additional information about the depth and durability of disease control in multiple myeloma.
By evaluating treatment effectiveness, safety, and MRD outcomes, this study aims to generate evidence that may support a more individualized approach to belantamab mafodotin-based therapy in patients with relapsed or refractory multiple myeloma. The results may help define treatment strategies that optimize the balance between disease control and treatment burden.
official title
Phase II, Multicenter, Randomized Study to Evaluate Safety and Efficacy of MRD-guided Therapy With Reduced Versus Standard Dose of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma (REBEL)