LINKER-MM5
Research type
Research Study
Full title
An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma
IRAS ID
1012839
Contact name
Gia Meltzer
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Research summary
This study is researching a drug called linvoseltamab (also called “study drug”) either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.
The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.
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)This is a randomized, open-label study. Randomized means each participant will be randomly assigned to a treatment group (by chance, like flipping a coin). Open-label means that everyone involved in the study will know which treatment each participant is given.
This study will include about 915 participants with Relapsed and/or Refractory Multiple Myeloma (RRMM) who are 18 years of age or older. Participants will be in either Part 1 or Part 2 of this study.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
25/NE/0220
Date of REC Opinion
18 Dec 2025
REC opinion
Further Information Favourable Opinion