Phase 1/2 Study of Linvoseltamab (Anti-BCMA X Anti-CD3 Bispecific Antibody) in Previously Untreated Patients With Symptomatic Multiple Myeloma

Multiple Myeloma

Phase 1: Incidence of dose-limiting toxicities (DLTs), Phase 1: Incidence of treatment-emergent adverse events (TEAEs), Phase 1: Severity of treatment-emergent adverse events (TEAEs), Phase 1: Incidence of adverse events of special interest (AESIs), Phase 1: Severity of adverse events of special interest (AESIs), Phase 2: Proportion of participants with a very good partial response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria, Phase 2 Transplant-eligible cohort: Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy, Phase 2 Transplant-eligible cohort: Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy, Phase 2 Transplant-ineligible cohort: Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II, Phase 2 Transplant ineligible cohort: Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II

Phase 1 and 2: Concentrations of Linvoseltamab in serum, Phase 1 and 2: Concentrations of total soluble B-cell maturation antigen (BCMA), Phase 1 and 2: Incidence of anti-drug antibodies (ADAs) to Linvoseltamab, Phase 1 and 2: Titer of ADAs to Linvoseltamab, Phase 1: Objective response rate (ORR) measured using the IMWG criteria, Phase 1: Duration of Response (DOR) measured using the IMWG criteria, Phase 1: Progression-free survival (PFS) measured using the IMWG criteria, Phase 1: Proportion of participants achieving MRD-negative status (at 10^-5) in participants with NDMM measured using the IMWG criteria, Phase 2: Incidence of treatment-emergent adverse events (TEAEs), Phase 2: Severity of TEAEs, Phase 2: Incidence of adverse events of special interest (AESIs), Phase 2: Severity of AESIs, Phase 2: ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Phase 2: MRD-negative status of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Phase 2: DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Phase 2: PFS of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Phase 2: Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician, Phase 2: Time to response (TTR) as measured using the IMWG criteria, Phase 2: ORR by risk levels, Phase 2: MRD-negative status by risk levels, Phase 2: DOR by risk levels, Phase 2: TTR by risk levels, Phase 2: PFS by risk levels, Phase 2: Incidence of MRD-negative status, Phase 2 Transplant-eligible cohort: Cluster of differentiation 34+ (CD34+) stem cell yield, Phase 2 Transplant-eligible cohort: Time to neutrophil engraftment, Phase 2 Transplant-eligible cohort: Time to platelet engraftment, Phase 2 Transplant-eligible cohort: PFS after ASCT followed by 3 cycles of linvoseltamab

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