Summary
Eligible participants will be randomly assigned to one of two treatment cohorts.
Cohort A: DVRd Induction + Tal-D Consolidation + Cilta-cel
Participants will undergo apheresis (a process where a machine removes blood stem cells or other parts of the blood from a person's bloodstream then returns the rest to the body), followed by four 28-day cycles of DVRd induction (daratumumab, bortezomib, lenalidomide and dexamethasone) and cilta-cel will be generated from the participants' T-cells selected from the apheresis product.
Upon completion of cilta-cel production, product release, and completion of induction, participants will begin consolidation with four 28-day cycles of Tal-D (talquetamab + daratumumab), followed by a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days); cilta-cel will be administered 5-7 days after the start of the conditioning regmine.
Cohort B: DVRd Induction + Cilta-cel + Tal-D and Tec-D Consolidation
Participants will undergo apheresis followed by four cycles of DVRd induction and CIlta-cel will be generated from the participants' T-cells selected from the apheresis product.
Upon completion of cilta-cel production, product relesase and completion of induction, participants will begin consolidation with a conditioning regimen (cyclophosphamide and fludarabine daily for 3 days) with infusion of cilta-cel 5-7 days after the start of the conditioning regimen.
Following cilta-cel infusion, alternating cycles of Tal-D (Cycle 1, 3, 5, and 7) and Tec-D (teclistamab + daratumumab) (Cycle 2, 4, 6, and 8) will be started, no earlier than Day 84 and no later than Day 168 post cilta-cel infusion. Each cycle of Tal-D and Tec-D (is 84 days which includes an extended treatment-free interval.