drugset / Trial / NCT07428369

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

NCT07428369

Phase 2/3 Withdrawn Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start
2026-06-05
Primary completion
2038-05-21
Completion
2038-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule
Comparator Daratumumab Monoclonal antibody
Comparator Dexamethasone Small molecule
Subject Lenalidomide Other / unclassified
Subject Linvoseltamab Monoclonal antibody

Indications