A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

High Risk Smoldering Multiple Myeloma (HR-SMM)

Clinical PFS per International Myeloma Working Group (IMWG) criteria, Biochemical PFS per IMWG criteria

Achievement of MRD CR at 10^-5 per IMWG criteria, Time to death, Achievement of Overall Response Rate (ORR) of Partial Response or better (≥PR) per IMWG criteria, Best Overall Response (BOR) per IMWG criteria, Achievement of MRD-negativity, Sustained MRD-negativity, Duration of MRD-negative CR, Duration Of Response (DOR) per IMWG criteria, Occurrence of Treatment-Emergent Adverse Events (TEAEs), Severity of TEAEs, Occurrence of Serious Adverse Events (SAEs), Change from baseline score in European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) scale, Change from baseline score in EORTC QLQ-C30 physical functioning scale, Change from baseline score in EORTC QLQ-C30 role functioning scale, Change from baseline score in EORTC QLQ-C30 emotional functioning scale, Change from baseline score in EORTC QLQ-C30 pain scale, Change from baseline score in EORTC QLQ-C30 fatigue scale, Change from baseline score in EORTC IL478 future perspectives scale, Change from baseline score in EuroQoL-5 Dimensions 5-Level Questionnaire Visual Analogue Scale (EQ-5D-5L VAS), Functional Assessment of Cancer Therapy (FACIT) - Item Global Population 5 (GP5) responses, Change from baseline in FACIT - Item GP5 score, Concentrations of linvoseltamab in serum, Occurrence of Anti-Drug Antibodies (ADAs) to linvoseltamab in serum, Magnitude of ADA to linvoseltamab in serum

No related papers found yet.