Clinical Trial

A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Study acronym: LINKER-MM8
Withdrawn Phase 2/3
View on ClinicalTrials.gov →
Why the trial stopped
Sponsor Decision
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)
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-06-19
notable Enrollment reduced: 1570 -> 0 participants 2026-06-19
Trial Details
NCT Number NCT07428369
Lead Sponsor Regeneron Pharmaceuticals
Conditions Multiple Myeloma (MM)
Start Date 2026-06-05
Primary Completion 2038-05-21 (estimated)
Study Completion 2038-05-21 (estimated)
Updated on ClinicalTrials.gov 2026-06-18