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

Last updated: April 7, 2026
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Bone Neoplasm

Leukemia

Multiple Myeloma

Treatment

Linvoseltamab

Clinical Study ID

NCT06140524
R5458-ONC-2257
2023-505242-25-00
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 Modificationof Diet in Renal Disease (MDRD) equation

Exclusion

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 studyenrollment, 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), orHepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplainedsigns of infection, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 116
Treatment Group(s): 1
Primary Treatment: Linvoseltamab
Phase: 2
Study Start date:
September 16, 2024
Estimated Completion Date:
May 18, 2032

Connect with a study center

  • Algemeen Ziekenhuis (AZ) Klina

    Brasschaat, Antwerpen 2930
    Belgium

    Active - Recruiting

  • Algemeen Ziekenhuis AZ Delta

    Roeselare, West-Vlaanderen 8800
    Belgium

    Active - Recruiting

  • Cork University Hospital

    Cork, T12 EC8P
    Ireland

    Active - Recruiting

  • Istituto Romagnolo per lo Studio Dei Tumori Dino Amadori

    Meldola, Forli-Cesena 47014
    Italy

    Active - Recruiting

  • San Paolo Hospital

    Milan, Lombardy 20142
    Italy

    Active - Recruiting

  • Wojewodzki Szpital Zespolony - Ludwik Rydygier Provincial Hospital

    Torun, Kuyavian-Pomeranian Voivodeship 87-100
    Poland

    Active - Recruiting

  • Pratia MCM Krakow

    Krakow, Malopolska 30-510
    Poland

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia 18014
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada 2517117, Andalusia 2593109 18014
    Spain

    Site Not Available

  • Hospital de Cabuenes

    Gijon, Asturias 33203
    Spain

    Site Not Available

  • Hospital De Cabuenes

    Gijon, Austurias 33203
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa 3108286, Barcelona 08221
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar 2518294, Murcia 2513413 30120
    Spain

    Site Not Available

  • Hospital de Cabuenes

    Gijón, Principality of Asturias 33203
    Spain

    Active - Recruiting

  • Hospital de Cabuenes

    Gijón 3121424, Principality of Asturias 3114710 33203
    Spain

    Site Not Available

  • Hospital Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital Sant Pau

    Barcelona 3128760, 08041
    Spain

    Site Not Available

  • Universitaru Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Universitaru Hospital La Princesa

    Madrid 3117735, 28006
    Spain

    Site Not Available

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008
    Spain

    Active - Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia 2513416, 30008
    Spain

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • University of Michigan Health

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan Health

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Stony Brook University Hospital

    Stony Brook 5139865, New York 5128638 11794
    United States

    Site Not Available

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • University of Washington

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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