DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared with the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants with Relapsed/Refractory Multiple Myeloma

Multiple Myeloma

Progression-Free Survival (PFS), defined as the time from the date of randomization until the earliest date of documented disease progression or death due to any cause

Overall Survival (OS), defined as the time from the date of randomization until the date of death due to any cause, Duration of Response (DoR), defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to any cause, Minimal Residual Disease (MRD) negativity rate, defined as the percentage of participants who are MRD negative by next-generation sequencing (NGS), Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better, Overall Response Rate (ORR), defined as the percentage of participants with a confirmed partial response (PR) or better, Clinical Benefit Rate (CBR), defined as the percentage of participants with a confirmed minimal response (MR) or better per IMWG, Time to Response (TTR), defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better, Time to Progression (TTP), defined as the time from the date of randomization until the earliest date of documented PD or death due to PD, PFS2, defined as time from randomization to disease progression after initiation of new anti-myeloma therapy or death from any cause, whichever is earlier., If disease progression after new anti-myeloma therapy cannot be measured, a PFS event is defined as the date of discontinuation of new anti-myeloma therapy, or death from any cause, whichever is earlier, Incidence of adverse events (AEs) and changes in laboratory parameters, Ocular findings on ophthalmic exam, Plasma concentrations of belantamab mafodotin, and cys-mcMMAF, Incidence and titers of ADAs against belantamab mafodotin, Maximum post-baseline PRO-CTCAE score for each item attribute, Change from baseline in HRQOL as measured by EORTC QLQ-C30 and EORTC IL52 (disease symptoms domain from the EORTC QLQ-MY20)

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