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: March 10, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Bone Neoplasm

Red Blood Cell Disorders

Treatment

Linvoseltamab

Clinical Study ID

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

Study Summary

The primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of high-risk monoclonal gammopathy of undetermined significance (HR-MGUS) and non high-risk smoldering multiple myeloma (NHR-SMM). This requires understanding the safety and tolerability of the study drug (how the body reacts to linvoseltamab) as well as the effectiveness of the study drug (how well linvoseltamab eliminates plasma cells). All participants will start treatment with gradually increasing doses of linvoseltamab (step-up doses) before they start receiving the assigned full dose.

The study is split into 2 parts:

  • In Part 1, separate groups of 3-6 patients will receive different full doses of linvoseltamab to evaluate the short-term side effects (safety) and tolerability of the study drug within the first 5 weeks after starting treatment. The data collected will help to make a decision about the dosing regimens chosen for Part 2.

  • In Part 2, a larger number of participants will be randomized to different dosing regimens to further assess the side effects of linvoseltamab, and to evaluate the ability of linvoseltamab to eliminate abnormal plasma cells in 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 m2 by the modification ofdiet 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 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 104
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

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia 18014
    Spain

    Active - Recruiting

  • Hospital de Cabuenes

    Gijon, Asturias 33203
    Spain

    Active - Recruiting

  • Hospital De Cabuenes

    Gijon, Austurias 33203
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona 08221
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Virgen De La Arrixaca

    El Palmar, Murcia 30120
    Spain

    Active - Recruiting

  • Hospital Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008
    Spain

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98109
    United States

    Active - Recruiting

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