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A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
Sponsor: Regeneron Pharmaceuticals
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)
Official title: A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2026-05-21
Completion Date
2033-07-27
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Linvoseltamab
Administered per the protocol
Daratumumab
Administered per the protocol
Locations (20)
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
Washington University School of Medicine in St. Louis
St Louis, Missouri, 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
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
University Hospitals Leicester
Leicester, United Kingdom