LINKER-MM3
Research type
Research Study
Full title
An Open-Label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti-BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients with Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
IRAS ID
1007325
Contact name
Hui Wang
Contact email
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Eudract number
2022-501396-62
Research summary
The study is researching an experimental drug called linvoseltamab, also called REGN5458.
Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no alternative treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumours), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).
This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after two to four prior treatments and have standard cancer treatment options available to them. The aim of the study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone (called “EPd” or “the EPd regimen” in this form), one of these standard treatment options. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. Both linvoseltamab and EPd will be referred to as “study drugs” in this form.
The study is looking at several other research questions, including:
• How long participants benefit from receiving linvoseltamab compared with EPd
• How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much
• What side effects happen from taking linvoseltamab compared to EPd
• How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd
• If there is any improvement in pain after treatment with linvoseltamab compared to EPd
• Exploratory research to better understand how linvoseltamab and EPd affect multiple myelomaREC name
West of Scotland REC 1
REC reference
23/WS/0090
Date of REC Opinion
2 Nov 2023
REC opinion
Further Information Favourable Opinion