A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment

Last updated: April 24, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cancer/tumors

Bone Neoplasm

Leukemia

Treatment

Linvoseltamab

Clinical Study ID

NCT05828511
R5458-ONC-2158
2022-500800-24-00
  • Ages > 18
  • All Genders

Study Summary

This study is researching an experimental drug called linvoseltamab (called "study drug"). The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are eligible for high dose chemotherapy with autologous stem cell transplantation (transplant-eligible) or ineligible for autologous stem cell transplantation (transplant-ineligible).

The aim of this clinical trial is to study the safety, tolerability (how the body reacts to the drug), and effectiveness (tumor shrinkage) of linvoseltamab in study participants with NDMM as a first step in determining if the study drug has a role in the treatment of NDMM.

This study consists of 2 phases:

  • In Phase 1, the study drug will be given to participants to study the side effects of the study drug and to establish the regimen (initial doses and full dose) of the study drug to be given to participants in Phase 2.

  • In Phase 2, the study drug will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of the study drug to shrink the tumor (multiple myeloma) in participants with NDMM.

The study is looking at several research questions, including:

  • What side effects may happen from taking linvoseltamab?

  • What the right dosing regimen is for linvoseltamab?

  • How many participants treated with linvoseltamab have improvement of their disease and for how long?

  • The effects of linvoseltamab study treatment before and after transplant

  • How much linvoseltamab is in the blood at different times?

  • Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

  2. Confirmed diagnosis of symptomatic multiple myeloma (MM) by International MyelomaWorking Group (IMWG) diagnosis criteria

  3. Measurable disease, according to the 2016 IMWG response criteria, as defined in theprotocol

  4. No prior therapy for MM, with the exception of prior emergent or palliativeradiation and up to 1 month of single-agent corticosteroids, with washout periods asper the protocol

  5. Participants must have evidence of adequate bone marrow reserves and hepatic, renaland cardiac function as defined in the protocol

  6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiacfunction to be considered transplant-eligible. The specific thresholds for adequateorgan function are as per institutional guidance.

Exclusion

Key Exclusion Criteria:

  1. Receiving any concurrent investigational agent with known or suspected activityagainst MM, or agents targeting the A proliferation-inducing ligand (APRIL)/Transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI)/BCMA axis

  2. Known central nervous system (CNS) involvement with MM, known or suspectedprogressive multifocal leukoencephalopathy (PML), a history of neurocognitiveconditions, or CNS movement disorder, or history of seizure within 12 months priorto study enrollment

  3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure orhypercalcemia not responsive to standard medical interventions), in urgent need oftreatment with chemotherapy

  4. Diagnosis of non-secretory MM, active plasma cell leukemia, primary light-chain (AL)amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or knownPOEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,endocrinopathy, monoclonal protein, and skin changes)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Linvoseltamab
Phase: 1/2
Study Start date:
December 19, 2023
Estimated Completion Date:
November 02, 2035

Connect with a study center

  • Gustave Roussy

    Villejuif, Ile De France 94800
    France

    Active - Recruiting

  • Hopital Necker

    Paris, Ile-de-France 75015
    France

    Active - Recruiting

  • Hopital Necker / Necker Hospital

    Paris, Ile-de-France 75015
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, Nouvelle-Aquitaine 86021
    France

    Active - Recruiting

  • Hospital Saint-Louis - APHP

    Paris, Île-de-France 75010
    France

    Active - Recruiting

  • CHU De Lille

    Lille, 59000
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 342950
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) Montpellier

    Montpellier, 342950
    France

    Active - Recruiting

  • Hopital Pitié Salpetriere APHP

    Paris, 75013
    France

    Active - Recruiting

  • Hopital Saint Louis

    Paris, 75010
    France

    Active - Recruiting

  • Hopital Universitaire Necker Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • Hospital Universitario Central De Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Active - Recruiting

  • Hospital General Universitario Doctor Balmis Alicante

    Alicante, Comunidad Valenciana 03010
    Spain

    Active - Recruiting

  • Hospital Universitario Quiron Salud Madrid

    Pozuelo de Alarcon, Madrid 28223
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Madrid, San Blas-Canillejas, Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario Politecnico La Fe

    Valencia, València 46026
    Spain

    Active - Recruiting

  • Hospital General Universitario de Alicante

    Alicante, 03010
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Institut Catala dOncologia (ICO Hospitalet)

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid, 28027
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • Universitary Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Instituto de Investigación Biomédica de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • La Fe University Hospital

    Valencia, 46026
    Spain

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California Los Angeles (UCLA)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • UC Irvine Health

    Orange, California 92868
    United States

    Active - Recruiting

  • UCI Health

    Orange, California 92868
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Colorado Blood Cancer Institute/SCRI

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Colorado Blood Cancer Instiute/SCRI

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Norton Healthcare, Inc.

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Perlmutter Cancer Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Atrium Health Levine Cancer

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • MD Anderson Cancer Centre

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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