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REBEL: Reduced vs Standard Dose Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma
NCT07748689Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Oct 2026
- Primary completion
- Mar 2033
- Sponsor
- Polish Myeloma Consortium
- Drugs
- belantamab mafodotin
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, randomised trial of belantamab mafodotin in multiple myeloma (MM) (2 arms), sponsored by Polish Myeloma Consortium. Primary endpoints: Overall Response Rate at 6 years and Incidence of Grade 2 or Higher Ocular Toxicity at 6 years. Planned start Oct 2026; status: not yet recruiting.
02
Design
2 arms- Study design
- Randomized
Reduced-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone
Belantamab mafodotin 2.5 mg/kg in Cycle 1 and 1.9 mg/kg thereafter + Pomalidomide + Dexamethasone
Standard-Dose Belantamab Mafodotin Plus Pomalidomide and Dexamethasone
Belantamab mafodotin 2.5 mg/kg in Cycle 1 and 1.9 mg/kg every 4 weeks thereafter + Pomalidomide + Dexamethasone
03
Who it enrols
Adults with relapsed/refractory multiple myeloma previously treated with at least 1 prior line including lenalidomide, with measurable disease, ECOG 0-2, and adequate organ function. Excludes prior treatment with pomalidomide and belantamab mafodotin, active infections, and significant cardiovascular or ocular diseases.
04
Endpoints
Primary
Overall Response Rate
Incidence of Grade 2 or Higher Ocular Toxicity
Secondary
Incidence and Severity of Adverse Events
Undetectable Measurable Residual Disease Rate
Sustained Undetectable Measurable Residual Disease Negativity Rate
Overall Response Rate
Complete Response Rate
Very Good Partial Response Rate
Duration of Response
Progression-Free Survival
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