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OncoMatch/Clinical Trials/NCT06140524

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

Is NCT06140524 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Linvoseltamab for monoclonal gammopathy of undetermined significance (mgus).

Phase 2RecruitingRegeneron PharmaceuticalsNCT06140524Data as of May 2026

Treatment: LinvoseltamabThis 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).

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

adequate hematologic function, as described in the protocol

Kidney function

estimated glomerular filtration rate (gfr) ≥30 ml/min/1.73 m^2 by the modification of diet in renal disease (mdrd) equation

Liver function

adequate hepatic function, as described in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Johns Hopkins Hospital · Baltimore, Maryland
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • University of Michigan Health · Ann Arbor, Michigan
  • Stony Brook University Hospital · Stony Brook, New York
  • Thomas Jefferson University Hospital · Philadelphia, Pennsylvania

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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