The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.
Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol.
NDMM with a requirement for treatment as documented per IMWG criteria.
Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or
Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia (defined as circulating plasma cells >5%).
Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma.
Signs of meningeal or central nervous system involvement with multiple myeloma.
Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery.
Parallel
Belantamab mafodotin
DrugBelantamab mafodotin will be administered.
Lenalidomide
DrugLenalidomide will be administered.
Dexamethasone
DrugDexamethasone will be administered.
Daratumumab
DrugDaratumumab will be administered.
PFS
Defined as the time from the date of randomization to the date of first documented PD per International Myeloma Working Group (IMWG) criteria by Independent Review Committee (IRC) or death from any cause in the absence of progression, whichever occurs first.
Number of Participants Achieving MRD Negative Status
Defined as achieving MRD negativity at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by next-generation sequencing (NGS) at least once during the time of confirmed complete response (CR) or better response per IMWG criteria by IRC.
Overall Survival (OS)
PFS2
Defined as the time from the date of randomization to the date of documented PD following the first subsequent anti-myeloma therapy or death from any cause, whichever is earlier.
Number of Participants Achieving CR or Better (CR+)
Number of Participants Achieving Very Good Partial Response (VGPR) or Better
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