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Linvoseltamab · LINKER-MGUS1

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

Ensayo de REGENERON PHARMACEUTICALS, INC. en Monoclonal Gammopathy of Undetermined Significance (MGUS) · Smoldering Multiple Myeloma (SMM) (del registro, en inglés).

Fase

Fase 2

Estado

Reclutando pacientes

Participantes

116

previstos

Centros

39

Fin del objetivo primario

may 2032

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2024.

Qué mide

Frequency of Adverse Events Interest (AEI) during the safety observation period (del registro, en inglés) (35 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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).

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT06140524), actualizada en jul 2026.