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

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 anti

Trial Details

NCT ID
NCT07393282
Phase
PHASE3
Sponsor
Regeneron Pharmaceuticals
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Linvoseltamab
  • Daratumumab
Locations (sample)
  • Atlanta, Georgia, United States|33.749,-84.38798
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Eastern Cooperative Oncology Group performance status score ≤1
  • SMM diagnosis per IMWG criteria as defined in the protocol
  • Meets HR-SMM criteria by 1 of the risk models as defined in the protocol
  • Key Exclusion Criteria:

For full eligibility, visit ClinicalTrials.gov.

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