The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed/refractory multiple myeloma bearing the translocation t(11;14)
Subjects must be ≥ 18 years of age.
Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Subjects must voluntarily sign and date an in-formed consent form
Cytogenetics/FISH confirming t(11;14)
Subject has received prior Venetoclax and/or anti BCMA treatment.
Participant has used an investigational drug or approved systemic anti-myeloma therapy with-in 14 days or five half-lives, whichever is short-er, preceding the first dose of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of Dexa-methasone 40 mg/day for a maximum of 4 days) up to 7 days before treatment.
Participant has had plasmapheresis or radia-tion therapy within 7 days prior to first dose of study treatment
Participant has current corneal epithelial dis-ease except mild changes in corneal epitheli-um
Sequential
Belantamab mafodotin, Venetoclax
DrugBelantamab mafodotin (IV) Venetoclax (PO)
Recommended Phase II dose (RP2D)
Establishment of Recommended Phase II dose (RP2D), Evaluation of safety profile, including maximum tolerated dose
Overall Response Rate
Overall Response Rate
Minimal residual disease (MRD) negativity
Minimal residual disease (MRD) negativity rate and duration
Progression free survival (PFS)
Progression free survival (PFS)
Duration of response (DOR)
Duration of response (DOR)
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