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Phase 3Recruiting

A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) (LINKER-SMM2)

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

Sponsor
Regeneron Pharmaceuticals (Industry)
Enrollment
270 planned
Conditions
High Risk Smoldering Multiple Myeloma (HR-SMM)
Interventions
Linvoseltamab; Daratumumab
Ages
adults, older adults
Registry
NCT07393282, CTIS2025-523252-31-00

Full record on ClinicalTrials.gov

From the registry

This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma. The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Primary outcomes

  • Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria
  • Biochemical PFS per IMWG criteria

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered