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 antibodies against the study drug (which could make the drug less effective or could lead to side effects)

NCT Number	NCT07393282
Lead Sponsor	Regeneron Pharmaceuticals
Conditions	High Risk Smoldering Multiple Myeloma (HR-SMM)
Enrollment	270 participants
Start Date	2026-05-21
Primary Completion	2033-07-27 (estimated)
Study Completion	2033-07-27 (estimated)
Updated on ClinicalTrials.gov	2026-08-07