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Un essai de fenêtre d'opportunité pour savoir si le linvoseltamab est sûr et bien toléré, et dans quelle mesure il fonctionne chez les participants atteints d'un myélome multiple récemment diagnostiqué qui n'ont pas encore reçu de traitement. (LINKER-MM4)

5 novembre 2026 mis à jour par: Regeneron Pharmaceuticals

Étude de phase 1/2 sur le linvoseltamab (anticorps bispécifique anti-BCMA X anti-CD3) chez des patients atteints de myélome multiple symptomatique n'ayant jamais été traités

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 Parts A and B, 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 1 Part C, the study drug will be given to participants to study the side effects when using different initial doses of the study drug.
  • 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 activity 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).

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

148

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Espagne
      • Barcelona, Espagne, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Espagne, 08908
        • Institut Catala dOncologia (ICO Hospitalet)
      • Madrid, Espagne, 28027
        • Clinica Universidad de Navarra - Madrid
      • Madrid, Espagne, 28006
        • Universitary Hospital La Princesa
      • Salamanca, Espagne, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Espagne, 46026
        • Hospital Universitari i Politecnic La Fe
    • Barcelona
      • Badalona, Barcelona, Espagne, 08916
        • Hospital Germans Trias i Pujol
    • Madrid
      • Pozuelo de Alarcón, Madrid, Espagne, 28223
        • Hospital Universitario Quiron Salud Madrid
    • Navarre
      • Pamplona, Navarre, Espagne, 31008
        • Clinica Universidad de Navarra
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Espagne, 33011
        • Hospital Universitario Central de Asturias
    • Valencia
      • Alicante, Valencia, Espagne, 03010
        • Hospital General Universitario Doctor Balmis Alicante
  • France
      • Lille, France, 59000
        • CHU De Lille
      • Montpellier, France, 342950
        • Centre Hospitalier Universitaire (CHU) Montpellier
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75651
        • University Hospitals Pitie Salpetriere - Charles Foix
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Centre Hospitalier Universitaire (CHU) de Poitiers
    • Île-de-France Region
      • Antony, Île-de-France Region, France, 92160
        • Hopital Prive d'Antony
      • Paris, Île-de-France Region, France, 75015
        • Hopital Necker
      • Villejuif, Île-de-France Region, France, 94800
        • Gustave Roussy
  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90095
        • University of California Los Angeles (UCLA)
      • Orange, California, États-Unis, 92868
        • UC Irvine Health
    • Colorado
      • Denver, Colorado, États-Unis, 80218
        • Colorado Blood Cancer Institute/SCRI
    • Kentucky
      • Louisville, Kentucky, États-Unis, 40207
        • Norton Cancer Institute
    • Michigan
      • Detroit, Michigan, États-Unis, 48201
        • Karmanos Cancer Institute
    • New Jersey
      • New Brunswick, New Jersey, États-Unis, 08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Mineola, New York, États-Unis, 11501
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
      • New York, New York, États-Unis, 10016
        • Perlmutter Cancer Center
      • New York, New York, États-Unis, 10032
        • Columbia University _ New York Presbyterian
      • Stony Brook, New York, États-Unis, 11794
        • Stony Brook University Hospital
    • North Carolina
      • Charlotte, North Carolina, États-Unis, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, États-Unis, 27705
        • Duke University Health System (DUHS)
    • Texas
      • Houston, Texas, États-Unis, 77030
        • The University of Texas MD Anderson Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 Myeloma Working Group (IMWG) diagnosis criteria, as described in the protocol
  3. Response-evaluable myeloma, according to the 2016 IMWG response criteria, as defined in the protocol
  4. No prior therapy for MM, with the exception of prior emergent or palliative radiation and up to 1 month of single-agent corticosteroids, with washout periods as per the protocol
  5. Participants must have evidence of adequate bone marrow reserves and hepatic, renal and cardiac function as defined in the protocol
  6. Participants must be age <70 and have adequate hepatic, renal, pulmonary and cardiac function to be considered transplant-eligible. The specific thresholds for adequate organ function are as per institutional guidance.

Key Exclusion Criteria:

  1. Receiving any concurrent investigational agent with known or suspected activity against 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 suspected Progressive Multifocal Leukoencephalopathy (PML), a history of neurocognitive conditions, or CNS movement disorder, or history of seizure within 12 months prior to study enrollment
  3. Rapidly progressive symptomatic disease, (e.g. progressing renal failure or hypercalcemia not responsive to standard medical interventions), in urgent need of treatment with chemotherapy
  4. Diagnosis of non-secretory MM, active plasma cell leukemia primary light-chain (AL) amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or known POEMS syndrome (Plasma cell dyscrasia with polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Phase 1 cohorts

Linvoseltamab dose escalation (part A), dose expansion (part B), and evaluation of alternative step-up regimen (part C) for participants with NDMM who are treatment-naïve.
Médicament: Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

Autres noms:
  • REGN5458
  • Lynozyfic ™
Expérimental: Phase 2 - transplant ineligible cohort

Transplant-ineligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen until disease progression as per protocol.
Médicament: Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

Autres noms:
  • REGN5458
  • Lynozyfic ™
Expérimental: Phase 2 - transplant eligible cohort

Transplant-eligible participants, enrolled in dose expansion, will receive selected linvoseltamab regimen for a fixed duration of treatment as per protocol
Médicament: Linvoseltamab

Linvoseltamab will be administered by intravenous (IV) infusion

Autres noms:
  • REGN5458
  • Lynozyfic ™

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of Dose-Limiting Toxicities (DLTs)
Délai: End of the Observation period; up to day 28

Phase 1
End of the Observation period; up to day 28
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Severity of TEAEs
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of Adverse Events of Special Interest (AESIs)
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Severity of AESIs
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Proportion of participants with a Very Good Partial Response (VGPR) or better using the International Myeloma Working Group (IMWG) response criteria
Délai: Up to 5 years

Phase 2
Up to 5 years
Proportion of participants achieving Minimal Residual Disease (MRD) negative status (at 10^-5) after induction with consolidation therapy
Délai: Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 years
Proportion of participants achieving MRD-negative status (at 10^-5) after induction without consolidation therapy
Délai: Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 years
Proportion of participants achieving MRD-negative status as their best response after treatment period I with continuing to treatment period II
Délai: Up to 5 years

Phase 2 Transplant-ineligible cohort
Up to 5 years
Proportion of participants achieving MRD-negative status as their best response after treatment period I without continuing to treatment period II
Délai: Up to 5 years

Phase 2 Transplant ineligible cohort
Up to 5 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Concentrations of Linvoseltamab in serum
Délai: Post-Last Linvoseltamab Dose, up to 12 weeks

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 12 weeks
Concentrations of total soluble B-Cell Maturation Antigen (BCMA)
Délai: Post-Last Linvoseltamab Dose, up to 12 weeks

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 12 weeks
Incidence of Anti-Drug Antibodies (ADAs) to Linvoseltamab
Délai: Post-Last Linvoseltamab Dose, up to 30 days

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 30 days
Magnitude of ADAs to Linvoseltamab
Délai: Post-Last Linvoseltamab Dose, up to 30 days

Phases 1 and 2
Post-Last Linvoseltamab Dose, up to 30 days
Objective Response Rate (ORR) measured using the IMWG criteria
Délai: Up to 5 years

Phase 1
Up to 5 years
Duration Of Response (DOR) measured using the IMWG criteria
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Progression-Free Survival (PFS) measured using the IMWG criteria
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Proportion of participants achieving MRD-negative status (at 10^-5) in participants with NDMM measured using the IMWG criteria
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 1
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of TEAEs
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Severity of TEAEs
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of AESIs
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Severity of AESIs
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
ORR of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Délai: Up to 5 years

Phase 2
Up to 5 years
MRD-negative status of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
DOR of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
PFS of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Overall Survival (OS) of participants deemed transplant-eligible and transplant-ineligible by the treating physician
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Time To Response (TTR) as measured using the IMWG criteria
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
ORR by risk levels
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
MRD-negative status by risk levels
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
DOR by risk levels
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
TTR by risk levels
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
PFS by risk levels
Délai: Post-Last Linvoseltamab Dose, up to 90 days

Phase 2
Post-Last Linvoseltamab Dose, up to 90 days
Incidence of MRD-negative status
Délai: Up to 5 years

Phase 2
Up to 5 years
Cluster of Differentiation 34+ (CD34+) stem cell yield
Délai: At cycle 4 of induction (each cycle is 28 days long)

Phase 2 Transplant-eligible cohort
At cycle 4 of induction (each cycle is 28 days long)
Time to neutrophil engraftment
Délai: Up to 100 days post-transplant

Phase 2 Transplant-eligible cohort
Up to 100 days post-transplant
Time to platelet engraftment
Délai: Up to 100 days post-transplant

Phase 2 Transplant-eligible cohort
Up to 100 days post-transplant
PFS after ASCT followed by 3 cycles of linvoseltamab
Délai: Up to 5 years

Phase 2 Transplant-eligible cohort
Up to 5 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Regeneron Pharmaceuticals

Les enquêteurs

  • Directeur d'études: Clinical Trial Management, Regeneron Pharmaceuticals

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

19 décembre 2023

Achèvement primaire (Estimé)

2 novembre 2035

Achèvement de l'étude (Estimé)

2 novembre 2035

Dates d'inscription aux études

Première soumission

12 avril 2023

Première soumission répondant aux critères de contrôle qualité

12 avril 2023

Première publication (Réel)

25 avril 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2026

Dernière vérification

1 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R5458-ONC-2158
  • 2022-500800-24-00 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Délai de partage IPD

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

Critères d'accès au partage IPD

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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