The purpose of this study is to compare the efficacy of teclistamab-daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd). Teclistamab is an new drug that is being evaluated to treat participants with multiple myeloma, an incurable malignant plasma cell disorder. This is a multicenter, randomized, open-label, Phase 3 study in multiple myeloma patients who have previously received 1 to 3 prior line(s) of therapy including a PI and lenalidomide.
Inclusion Criteria
1. Documented multiple myeloma as defined by: multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, or measurable disease at screening.
2. Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide.
3. Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen.
Exclusion Criteria
1. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
2. Received any prior B cell maturation antigen (BCMA)-directed therapy.
3. Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG.
Study Requirements
Approximately 560 participants will be randomly assigned in a 1:1 ratio to receive either Tec-Dara (Arm A) or investigator's choice of DPd/DVd (Arm B). The study will be conducted in 3 phases for each participant: (1)Screening, (2)Treatment and (3)Follow-up. Disease evaluation will occur every cycle. The overall duration of the study will be up to 5 years and 2 months after the last participant is randomized. Study treatment will be administered on 28-day cycles for Tec-Dara (Arm A) and DPd (Arm B). For DVd (Arm B), study treatment will be administered on 21-day cycles for Cycles 1 to 8 and 28-day cycles for Cycles 9+.
