drugset / Trial / NCT07393282

A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)

NCT07393282

Phase 3 Recruiting 270 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is researching an experimental drug called linvoseltamab (also called "study drug") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma. The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM. 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)

Timeline

Start
2026-05-21
Primary completion
2033-07-27
Completion
2033-07-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Daratumumab Monoclonal antibody
Subject Linvoseltamab Monoclonal antibody