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Study identifier: NCT06140524 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

Condition: Monoclonal Gammopathy of Undetermined Significance (MGUS) · Smoldering Multiple Myeloma (SMM)  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 2
Planned participants116
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study is researching an investigational drug called linvoseltamab ("study drug") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM). The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM? * 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).

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Administrator  ·  844-734-6643  ·  clinicaltrials@regeneron.com

Always discuss trial participation with your own doctor first.

Locations (39)

Johns Hopkins HospitalBaltimore, Maryland, United StatesRecruiting
Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
University of Michigan HealthAnn Arbor, Michigan, United StatesRecruiting
NYU Langone Health Perlmutter Cancer CenterNew York, New York, United StatesRecruiting
Stony Brook University HospitalStony Brook, New York, United StatesRecruiting
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania, United StatesRecruiting
University of WashingtonSeattle, Washington, United StatesRecruiting
Algemeen Ziekenhuis (AZ) KlinaBrasschaat, Antwerpen, BelgiumRecruiting
AZ St.-Elisabeth Herentals vzwHerentals, Antwerp, BelgiumRecruiting
AZ Sint Maarten Algemeen Ziekenhuis EmmausMechelen, Flanders, BelgiumRecruiting
Algemeen Ziekenhuis St Jan Brugge Oostende AvBruges, West-Vlaanderen, BelgiumRecruiting
Algemeen Ziekenhuis AZ DeltaRoeselare, West-Vlaanderen, BelgiumRecruiting

+ 27 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06140524