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A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)
Sponsor: Regeneron Pharmaceuticals
Summary
This study is focused on participants with Newly Diagnosed Multiple Myeloma (NDMM) who are eligible for high dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT). This study is evaluating a drug called linvoseltamab in combination with standard therapies for multiple myeloma called bortezomib (V) and lenalidomide (R). This combination is abbreviated as Linvo-VR. The aim of this study is to compare how well Linvo-VR, with and without ASCT, treats myeloma to how well the current standard of care regimen for NDMM treats myeloma. That current standard of care regimen includes the drugs daratumumab (D), bortezomib (V), lenalidomide (R), and dexamethasone (d). This combination is referred to as DVRd. The study is also evaluating if Linvo-VR treats myeloma well enough that ASCT is no longer needed with the first myeloma treatments. The study is looking at several other research questions, including: * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against the linvoseltamab (which could make the drug less effective or could lead to side effects)
Official title: A Phase 2/3, Open-Label, Randomized Study of Linvoseltamab, Bortezomib and Lenalidomide (Linvo-VR) With and Without Autologous Stem Cell Transplantation (ASCT) Vs Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) in Transplant-Eligible Participants With Newly Diagnosed Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1570
Start Date
2026-06-05
Completion Date
2038-05-21
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Linvoseltamab
Administered per the protocol
Bortezomib
Administered per the protocol
Lenalidomide
Administered per the protocol
Daratumumab
Administered per the protocol
Dexamethasone
Administered per the protocol