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.
Parallel
Belantamab Mafodotin
DrugBelantamab mafodotin is administered intravenously in combination with pomalidomide and dexamethasone. The study evaluates a reduced-dose strategy versus a standard-dose strategy of belantamab mafodotin in patients with relapsed or refractory multiple myeloma.
Pomalidomide
DrugPomalidomide is administered orally in combination with belantamab mafodotin and dexamethasone. Participants receive pomalidomide according to the protocol-defined treatment regimen
Dexamethasone
DrugDexamethasone is administered orally in combination with belantamab mafodotin and pomalidomide. Participants receive dexamethasone according to the protocol-defined treatment regimen
Overall Response Rate (ORR)
Overall Response Rate (ORR), defined as the proportion of participants achieving at least a partial response according to International Myeloma Working Group (IMWG) response criteria.
Incidence of Grade 2 or Higher Ocular Toxicity
Incidence of ocular toxicity of at least Grade 2 severity, assessed using the keratopathy and visual acuity (KVA) scale and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Incidence and Severity of Adverse Events
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), Grade 3 or higher adverse events, and Grade 3 or higher laboratory toxicities, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
Undetectable Measurable Residual Disease (uMRD) Rate
Percentage of participants with measurable residual disease (MRD) less than 10\^-5 in bone marrow among participants in complete response at 6, 12, 18, 24, 30, 36, and 42 months from randomization.
Sustained Undetectable Measurable Residual Disease (uMRD) Negativity Rate
Percentage of participants with sustained undetectable measurable residual disease (uMRD) negativity, defined as two consecutive MRD-negative results in participants with complete response separated by at least 12 months.
Overall Response Rate (ORR)
Percentage of participants achieving an overall response, including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to International Myeloma Working Group (IMWG) criteria.
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Polish Myeloma Consortium
Lead sponsor
Medical Research Agency, Poland
Collaborator
GlaxoSmithKline
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
