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En undersøgelse til sammenligning af Linvoseltamab-monoterapi og Linvoseltamab + Carfilzomib-kombinationsbehandling med standardkombinationsbehandlinger hos voksne deltagere med recidiv/refraktær multipel myelom (RRMM) (LINKER-MM5)

3. november 2026 opdateret af: Regeneron Pharmaceuticals

En åben, randomiseret fase 3-undersøgelse af Linvoseltamab-monoterapi og Linvoseltamab plus Carfilzomib versus standardkombinationsregimer hos patienter med recidiverende/refraktær myelomatose

This study is researching a drug called linvoseltamab (also called "study drug") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.

The aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.

The study is looking at several other research questions, including:

  • 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)

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

915

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
      • Adelaide, Australien, 5000
        • Rekruttering
        • Royal Adelaide Hospital
    • Queensland
      • Benowa, Queensland, Australien, 4211
        • Rekruttering
        • Pindara Private Hospital
      • Brisbane, Queensland, Australien, 4101
        • Rekruttering
        • Mater Misericordiae Ltd
      • Southport, Queensland, Australien, 4215
        • Rekruttering
        • Gold Coast Hospital and Health Service
    • Victoria
      • East Melbourne, Victoria, Australien, 3121
        • Rekruttering
        • Epworth Freemasons
      • Heidelberg, Victoria, Australien, 3084
        • Rekruttering
        • Austin Hospital
      • Melbourne, Victoria, Australien, 3004
        • Rekruttering
        • Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australien, 6000
        • Rekruttering
        • Royal Perth Hospital
  • Brasilien
      • São Paulo, Brasilien, 01509-010
        • Rekruttering
        • AC Camargo Cancer Center
      • São Paulo, Brasilien, 04537-080
        • Rekruttering
        • Clinica Medica Sao Germano
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30110-022
        • Rekruttering
        • Cetus Oncologia
    • Paraná
      • Curitiba, Paraná, Brasilien, 81520-060
        • Rekruttering
        • Hospital Erasto Gaertner
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
        • Rekruttering
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90110-270
        • Rekruttering
        • Centro Gaucho Integrado, Hospital Mae de Deus
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brasilien, 24220-300
        • Rekruttering
        • Oncomed Clinica Oncologica
    • Santa Catarina
      • Joinville, Santa Catarina, Brasilien, 89201-260
        • Rekruttering
        • Centro de Hematologia e Oncologia
      • Lages, Santa Catarina, Brasilien, 88501-001
        • Rekruttering
        • ANIMI
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14051-140
        • Rekruttering
        • Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo
  • Chile
    • Las Condes
      • Santiago, Las Condes, Chile, 7620157
        • Rekruttering
        • Hospital Clinico Universidad de Los Andes
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 6681920
        • Rekruttering
        • Clinica Alemana de Santiago
      • Santiago, Santiago Metropolitan, Chile, 7550000
        • Rekruttering
        • Clinica UC San Carlos de Apoquindo
      • Santiago, Santiago Metropolitan, Chile, 7560908
        • Rekruttering
        • OncoPrecision
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2540488
        • Rekruttering
        • Centro de Investigaciones Clinicas Vina del Mar
  • Det Forenede Kongerige
      • Dundee, Det Forenede Kongerige, DD1 9SY
        • Rekruttering
        • Ninewells Hospital and Medical School
      • Manchester, Det Forenede Kongerige, M13 9WL
        • Rekruttering
        • University of Manchester, Manchester Royal Infirmary
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Det Forenede Kongerige, AB25 2ZN
        • Rekruttering
        • Aberdeen Royal Infirmary
    • Cornwall
      • Truro, Cornwall, Det Forenede Kongerige, TR1 3LJ
        • Rekruttering
        • Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
    • Devon
      • Plymouth, Devon, Det Forenede Kongerige, PL6 8DH
        • Rekruttering
        • University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
    • Norfolk
      • Norwich, Norfolk, Det Forenede Kongerige, NR4 7UY
        • Rekruttering
        • Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Rekruttering
        • The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital
    • West Midlands
      • Birmingham, West Midlands, Det Forenede Kongerige, B15 2GW
        • Rekruttering
        • University Hospitals Birmingham NHS Trust, Center for Clinical
  • Forenede Stater
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Rekruttering
        • Emory Winship Cancer Institute
    • New York
      • New York, New York, Forenede Stater, 10021
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
      • Stony Brook, New York, Forenede Stater, 11794
        • Rekruttering
        • Stony Brook University Hospital
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43214
        • Rekruttering
        • OhioHealth
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Rekruttering
        • Baylor University Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • Rekruttering
        • University of Texas Health Science Center, Houston
  • Sydkorea
      • Seoul, Sydkorea, 05505
        • Rekruttering
        • Asan Medical Center
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
      • Seoul, Sydkorea, 06351
        • Rekruttering
        • Samsung Medical Center
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Severance Hospital; Division of Hematology
      • Seoul, Sydkorea, 06591
        • Rekruttering
        • Seoul St. Mary's Hospital, The Catholic University of Korea
      • Ulsan, Sydkorea, 44033
        • Rekruttering
        • Ulsan University Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Sydkorea, 58128
        • Rekruttering
        • Chonnam National University Hwasun Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Rekruttering
        • Kaohsiung Medical University Hospital
      • Taichung, Taiwan, 40705
        • Rekruttering
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 116
        • Rekruttering
        • Taipei Municipal Wan Fang Hospital
      • Taipei, Taiwan, 106
        • Rekruttering
        • National Taiwan University Hospital
    • Hunan Province
      • Taoyuan, Hunan Province, Taiwan, 33305
        • Rekruttering
        • Chang Gung Memorial Hospital - Linkou Branch
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06680
        • Rekruttering
        • Ankara Liv Hospital
      • Istanbul, Tyrkiet (Türkiye), 34214
        • Rekruttering
        • Istanbul Florence Nightingale Hospital
      • Izmir, Tyrkiet (Türkiye), 35575
        • Rekruttering
        • Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)
    • Ankara
      • Mamak, Ankara, Tyrkiet (Türkiye), 06620
        • Rekruttering
        • Ankara University Faculty of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Key Inclusion Criteria:

  1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
  2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
  3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Key Exclusion Criteria:

  1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
  2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
  4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder

NOTE: Other protocol defined inclusion/exclusion criteria apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Del 1: Arm A
Medicin: Linvoseltamab

Administered per the protocol

Andre navne:
  • REGN5458
  • Lynozyfic ™
Eksperimentel: Del 1: Arm B
Medicin: Linvoseltamab

Administered per the protocol

Andre navne:
  • REGN5458
  • Lynozyfic ™
Medicin: Carfilzomib

Administered per the protocol

Andre navne:
  • Kyprolis®
Eksperimentel: Del 2: Arm A
Medicin: Linvoseltamab

Administered per the protocol

Andre navne:
  • REGN5458
  • Lynozyfic ™
Eksperimentel: Del 2: Arm B
Medicin: Linvoseltamab

Administered per the protocol

Andre navne:
  • REGN5458
  • Lynozyfic ™
Medicin: Carfilzomib

Administered per the protocol

Andre navne:
  • Kyprolis®
Eksperimentel: Del 2: Arm C
Medicin: Carfilzomib

Administered per the protocol

Andre navne:
  • Kyprolis®
Medicin: Daratumumab

Administered per the protocol

Andre navne:
  • Darzalex®
  • Darzalex Faspro®
Medicin: Dexamethasone

Administered per the protocol

Andre navne:
  • Dexahexal®
Medicin: Pomalidomide

Administered per the protocol

Andre navne:
  • Pomalyst®
  • Imnovid®
Medicin: Bortezomib

Administered per the protocol

Andre navne:
  • Velcade®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 5 years

Part 1
Up to 5 years
Severity of TEAEs
Tidsramme: Up to 5 years

Part 1
Up to 5 years
Occurrence of Adverse Events of Special Interest (AESI)
Tidsramme: Up to 5 years

Part 1
Up to 5 years
Severity of AESIs
Tidsramme: Up to 5 years

Part 1
Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
Tidsramme: Up to 5 years

Part 1
Up to 5 years
Severity of SAEs
Tidsramme: Up to 5 years

Part 1
Up to 5 years
Minimal Residual Disease (MRD)-negative Complete Response (CR)
Tidsramme: At 12 months

Part 2
At 12 months
Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC
Tidsramme: Up to 5 years

Part 2
Up to 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)
Tidsramme: Up to 28 days

Part 1
Up to 28 days
Timing of grade ≥2 CRS
Tidsramme: Up to 28 days

Part 1
Up to 28 days
Overall Survival (OS)
Tidsramme: Up to 7 years

Part 2
Up to 7 years
Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Achievement of CR or better per IMWG response criteria as determined by BIRC
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Duration Of Response (DOR) as per IMWG response criteria
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Time To Progression (TTP) as per IMWG response criteria
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Time To Next Treatment (TTNT)
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Second PFS
Tidsramme: Up to 5 years

Part 2
Up to 5 years
MRD-negative CR criteria at any time
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Time to PR IMWG response category
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Time to VGPR IMWG response category
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Time to CR IMWG response category
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Time to stringent Complete Response (sCR) IMWG response category
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Sustained MRD-negative CR
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Duration of MRD-negative CR
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Occurrence of TEAEs
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Severity of TEAEs
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Occurrence of AESIs
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Severity of AESIs
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Occurrence of SAEs
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Severity of SAEs
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Concentrations of linvoseltamab in serum over time
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Incidence of Antidrug Antibodies (ADAs) to linvoseltamab
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Magnitude of ADAs to linvoseltamab
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Tidsramme: Up to 5 years

Part 2 The EORTC QLQ-C30 is a 30-item validated questionnaire developed to measure patient-reported QoL using 1 GHS/QoL scale, 5 functioning scales (physical, role, emotional, cognitive and social) and 9 symptom scales / items (fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) among patients with cancer.

Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
Up to 5 years
Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Change from baseline in Role Functioning (RF), per EORTC QLQ-C30
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Change from baseline in pain, per EORTC QLQ-C30
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Change from baseline in fatigue, per EORTC QLQ-C30
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])
Tidsramme: Up to 5 years

Part 2 EORTC QLQ-MY20 is an accompanying 20-item validated questionnaire that measure quality of life among patients living with MM across 4 scales (disease symptoms, side effect of treatment, body image and future perspective). A high score represents a high level of symptoms or problems.
Up to 5 years
Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20
Tidsramme: Up to 5 years

Part 2
Up to 5 years
Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)
Tidsramme: Up to 5 years

Part 2 The EQ-5D-5L is a generic questionnaire that measures HRQoL across 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) across 5 levels (no problems, slight problems, some problems, severe problems and extreme problems) and a VAS of pain (where 0: no pain and 10: worst pain), higher scores indicate higher pain.
Up to 5 years
Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5
Tidsramme: Up to 5 years

Part 2 FACIT Item GP5 is a recommended item by the Federal Drug Administration (FDA) in its recent draft guidance for cancer trials to assess patient-reported overall impact of treatment toxicity. It uses a single item "I am bothered by side effects of treatment" on a 5-point scale (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much)
Up to 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2026

Primær færdiggørelse (Anslået)

21. maj 2029

Studieafslutning (Anslået)

23. august 2034

Datoer for studieregistrering

Først indsendt

28. oktober 2025

Først indsendt, der opfyldte QC-kriterier

28. oktober 2025

Først opslået (Faktiske)

30. oktober 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R5458-ONC-2246
  • 2024-519504-27-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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