RecruitingPhase 3NCT07393282

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

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma


Sponsor

Regeneron Pharmaceuticals

Enrollment

270 participants

Start Date

May 21, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Daratumumab and a drug called Linvoseltamab for people with high risk smoldering multiple myeloma (hr-smm). The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinvoseltamab

Administered per the protocol

DRUGDaratumumab

Administered per the protocol


Locations(14)

Mayo Clinic Phoenix, Mayo Clinic Building

Phoenix, Arizona, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Dana Farber / Harvard Cancer Center

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute - Detroit

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Ohio State University

Columbus, Ohio, United States

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, Japan

Tokushima Prefectural Central Hospital

Tokushima, Tokushima, Japan

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, Japan

National Hospital Organization Matsumoto Medical Center

Matsumoto-shi, Japan

The Catholic University of Korea, St Vincents Hospital

Suwon, Gyeonggi-do, South Korea

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07393282