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RecruitingInterventionalPhase 2

Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma

NCT ID: NCT06140524Sponsor: Regeneron PharmaceuticalsLast updated: 2026-06-15

Summary

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).

Arms & interventions

  • DrugLinvoseltamab

    Administered per the protocol

Outcome measures

Primary

  • Frequency of Adverse Events Interest (AEI) during the safety observation period

    Part 1 An AEI is a toxicity potentially related to study treatment that may preclude dose escalation or expansion according to the Bayesian Optimal Interval (BOIN) design decision rules

    Time frame: 35 days

  • Frequency of Treatment-Emergent Adverse Event (TEAEs) during the safety observation period

    Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)

    Time frame: 35 days

  • Severity of TEAEs during the safety observation period

    Part 1 As assessed by the NCI-CTCAE grading system version 5 (for all grades)

    Time frame: 35 days

  • Achievement of Complete Response (CR) as determined by the investigator

    Part 2

    Time frame: Up to 5.5 years

Secondary

  • Frequency of TEAEs

    Time frame: Up to 5.5 years

  • Severity of TEAEs

    Time frame: Up to 5.5 years

  • Frequency of Serious Adverse Events (SAEs)

    Time frame: Up to 5.5 years

  • Severity of SAEs

    Time frame: Up to 5.5 years

  • Frequency of laboratory abnormalities

    Time frame: Up to 5.5 years

  • Severity of laboratory abnormalities

    Time frame: Up to 5.5 years

  • Minimal Residual Disease (MRD) negativity among participants that achieve a response of CR

    Time frame: Up to 5.5 years

  • Sustained MRD negativity on an annual basis

    Time frame: Up to 3 years after achievement of CR

  • Overall response of Partial Response (PR) or better as determined by the investigator

    Time frame: Up to 5.5 years

  • Duration Of Response (DOR) as determined by the investigator

    Time frame: Up to 5.5 years

  • Biochemical Progression-Free Survival (PFS) as determined by the investigator

    Time frame: Up to 5.5 years

  • Concentration of linvoseltamab in serum over time

    Time frame: Up to 9 months

  • Incidence of Anti-Drug Antibodies (ADAs) to linvoseltamab over the study duration

    Time frame: Up to 5.5. years

  • Magnitude of ADAs to linvoseltamab over the study duration

    Time frame: Up to 5.5. years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria: 1. HR-MGUS or NHR-SMM as defined in the protocol 2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 3. Adequate hematologic and hepatic function, as described in the protocol 4. Estimated glomerular filtration rate (GFR) ≥30 mL/min/1.73 m\^2 by the Modification of Diet in Renal Disease (MDRD) equation Key Exclusion Criteria: 1. High-risk SMM, as defined in the protocol 2. Evidence of any of myeloma-defining events, as described in the protocol 3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM 4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol 5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab 6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply

Study locations (7)

Johns Hopkins Hospital

Baltimore, Maryland, 21287

Recruiting

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting

University of Michigan Health

Ann Arbor, Michigan, 48109

Recruiting

NYU Langone Health Perlmutter Cancer Center

New York, New York, 10016

Recruiting

Stony Brook University Hospital

Stony Brook, New York, 11794

Recruiting

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Recruiting

University of Washington

Seattle, Washington, 98109

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 | Cancerify