LINKER-SMM2
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
IRAS ID
1013965
Contact name
Nishant Naik
Contact email
Sponsor organisation
Regeneron Pharmaceuticals Inc
Eudract number
2025-523252-31
Clinicaltrials.gov Identifier
Research summary
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)REC name
Wales REC 1
REC reference
26/WA/0164
Date of REC Opinion
7 Jul 2026
REC opinion
Further Information Favourable Opinion