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.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the REBEL study protocol.
Male or female, 18 years or older (at the time consent is obtained).
Have a confirmed diagnosis of MM as defined by the IMWG criteria.
Eastern Cooperative Oncology Group performance status of 0-2.
Active plasma cell leukemia, amyloidosis, POEMS syndrome, allogeneic SCT or currently active GvHD.
Anti-MM therapy or use of an investigational drug within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; Prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs.
Plasmapheresis within 7 days prior to the first dose of study drug.
Prior treatment with pomalidomide and belantamab mafodotin in any treatment line.
Polish Myeloma Consortium
Lead sponsor
Medical Research Agency, Poland
Collaborator
GlaxoSmithKline
Collaborator