An Open-label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab plus Carfilzomib versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma

Relapsed Refractory Multiple Myeloma

Part 1 - Occurrence of Treatment Emergent Adverse Events (TEAEs), Part 1 - Severity of TEAEs, Part 1 - Occurrence of Adverse Events of Special Interest (AESI), Part 1 - Severity of AESIs, Part 1 - Occurrence of Serious Adverse Events (SAEs), Part 1 - Severity of SAEs, Part 2 - Minimal Residual Disease (MRD) -negative Complete response (CR), Part 2 - Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC

Part 1 - Occurrence of grade ≥2 Cytokine Release Syndrome (CRS), Part 1 - Timing of grade ≥2 CRS, Part 2 - Overall Survival (OS), Part 2 - Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC, Part 2 - Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC, Part 2 - Achievement of CR or better per IMWG response criteria as determined by BIRC, Part 2 - Duration Of Response (DOR) as per IMWG response criteria, Part 2 - Time To Progression (TTP) as per IMWG response criteria, Part 2 - Time To Next Treatment (TTNT), Part 2 - Second PFS, Part 2 - MRD-negative CR criteria at any time, Part 2 - Time to PR IMWG response category, Part 2 - Time to VGPR IMWG response category, Part 2 - Time to CR IMWG response category, Part 2 - Time to stringent Complete Response (sCR) IMWG response category, Part 2 - Sustained of MRD-negative CR, Part 2 - Duration of MRD-negative CR, Part2 - Occurrence of TEAEs, Part 2 - Severity of TEAEs, Part 2 - Occurrence of AESIs, Part 2 - Severity of AESIs, Part 2 - Occurrence of SAEs, Part 2 - Severity of SAEs, Part 2 - Concentrations of linvoseltamab in serum over time, Part 2 - Incidence of Antidrug Antibodies (ADAs) to linvoseltamab, Part 2 - Magnitude of ADAs to linvoseltamab, Part 2 - Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time, Part 2 - Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQLQ-C30), Part 2 - Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30, Part 2 - Change from baseline in Role Functioning (RF), per EORTC QLQ-C30, Part 2 - Change from baseline in pain, per EORTC QLQ-C30, Part 2 - Change from baseline in fatigue, per EORTC QLQ-C30, Part 2 - Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]), Part 2 - Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20, Part 2 - Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS), Part 2 - Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5

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