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En studie for å sammenligne Linvoseltamab-monoterapi og Linvoseltamab + Carfilzomib-kombinasjonsterapi med standardbehandlingskombinasjonsregimer hos voksne deltakere med tilbakevendende/refraktær multipelt myelom (RRMM) (LINKER-MM5)

3. november 2026 oppdatert av: Regeneron Pharmaceuticals

En åpen, randomisert fase 3-studie av Linvoseltamab-monoterapi og Linvoseltamab pluss Carfilzomib versus standard behandlingskombinasjonsregimer hos pasienter med tilbakevendende/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)

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

915

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
      • Adelaide, Australia, 5000
        • Rekruttering
        • Royal Adelaide Hospital
    • Queensland
      • Benowa, Queensland, Australia, 4211
        • Rekruttering
        • Pindara Private Hospital
      • Brisbane, Queensland, Australia, 4101
        • Rekruttering
        • Mater Misericordiae Ltd
      • Southport, Queensland, Australia, 4215
        • Rekruttering
        • Gold Coast Hospital and Health Service
    • Victoria
      • East Melbourne, Victoria, Australia, 3121
        • Rekruttering
        • Epworth Freemasons
      • Heidelberg, Victoria, Australia, 3084
        • Rekruttering
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • Rekruttering
        • Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Rekruttering
        • Royal Perth Hospital
  • Brasil
      • São Paulo, Brasil, 01509-010
        • Rekruttering
        • AC Camargo Cancer Center
      • São Paulo, Brasil, 04537-080
        • Rekruttering
        • Clinica Medica Sao Germano
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30110-022
        • Rekruttering
        • Cetus Oncologia
    • Paraná
      • Curitiba, Paraná, Brasil, 81520-060
        • Rekruttering
        • Hospital Erasto Gaertner
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Rekruttering
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90110-270
        • Rekruttering
        • Centro Gaucho Integrado, Hospital Mae de Deus
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brasil, 24220-300
        • Rekruttering
        • Oncomed Clinica Oncologica
    • Santa Catarina
      • Joinville, Santa Catarina, Brasil, 89201-260
        • Rekruttering
        • Centro de Hematologia e Oncologia
      • Lages, Santa Catarina, Brasil, 88501-001
        • Rekruttering
        • ANIMI
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasil, 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
  • Forente stater
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Rekruttering
        • Emory Winship Cancer Institute
    • New York
      • New York, New York, Forente stater, 10021
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
      • Stony Brook, New York, Forente stater, 11794
        • Rekruttering
        • Stony Brook University Hospital
    • Ohio
      • Columbus, Ohio, Forente stater, 43214
        • Rekruttering
        • OhioHealth
    • Texas
      • Dallas, Texas, Forente stater, 75246
        • Rekruttering
        • Baylor University Medical Center
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • University of Texas Health Science Center, Houston
  • Storbritannia
      • Dundee, Storbritannia, DD1 9SY
        • Rekruttering
        • Ninewells Hospital and Medical School
      • Manchester, Storbritannia, M13 9WL
        • Rekruttering
        • University of Manchester, Manchester Royal Infirmary
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, Storbritannia, AB25 2ZN
        • Rekruttering
        • Aberdeen Royal Infirmary
    • Cornwall
      • Truro, Cornwall, Storbritannia, TR1 3LJ
        • Rekruttering
        • Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
    • Devon
      • Plymouth, Devon, Storbritannia, PL6 8DH
        • Rekruttering
        • University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
    • Norfolk
      • Norwich, Norfolk, Storbritannia, NR4 7UY
        • Rekruttering
        • Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
    • Surrey
      • Sutton, Surrey, Storbritannia, SM2 5PT
        • Rekruttering
        • The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital
    • West Midlands
      • Birmingham, West Midlands, Storbritannia, B15 2GW
        • Rekruttering
        • University Hospitals Birmingham NHS Trust, Center for Clinical
  • Sør -Korea
      • Seoul, Sør -Korea, 05505
        • Rekruttering
        • Asan Medical Center
      • Seoul, Sør -Korea, 03080
        • Rekruttering
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 06351
        • Rekruttering
        • Samsung Medical Center
      • Seoul, Sør -Korea, 03722
        • Rekruttering
        • Severance Hospital; Division of Hematology
      • Seoul, Sør -Korea, 06591
        • Rekruttering
        • Seoul St. Mary's Hospital, The Catholic University of Korea
      • Ulsan, Sør -Korea, 44033
        • Rekruttering
        • Ulsan University Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Sør -Korea, 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
  • Tyrkia (Türkiye)
      • Ankara, Tyrkia (Türkiye), 06680
        • Rekruttering
        • Ankara Liv Hospital
      • Istanbul, Tyrkia (Türkiye), 34214
        • Rekruttering
        • Istanbul Florence Nightingale Hospital
      • Izmir, Tyrkia (Türkiye), 35575
        • Rekruttering
        • Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)
    • Ankara
      • Mamak, Ankara, Tyrkia (Türkiye), 06620
        • Rekruttering
        • Ankara University Faculty of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Del 1: Arm A
Legemiddel: Linvoseltamab

Administered per the protocol

Andre navn:
  • REGN5458
  • Lynozyfic ™
Eksperimentell: Del 1: Arm B
Legemiddel: Linvoseltamab

Administered per the protocol

Andre navn:
  • REGN5458
  • Lynozyfic ™
Legemiddel: Carfilzomib

Administered per the protocol

Andre navn:
  • Kyprolis®
Eksperimentell: Del 2: Arm A
Legemiddel: Linvoseltamab

Administered per the protocol

Andre navn:
  • REGN5458
  • Lynozyfic ™
Eksperimentell: Del 2: Arm B
Legemiddel: Linvoseltamab

Administered per the protocol

Andre navn:
  • REGN5458
  • Lynozyfic ™
Legemiddel: Carfilzomib

Administered per the protocol

Andre navn:
  • Kyprolis®
Eksperimentell: Del 2: Arm C
Legemiddel: Carfilzomib

Administered per the protocol

Andre navn:
  • Kyprolis®
Legemiddel: Daratumumab

Administered per the protocol

Andre navn:
  • Darzalex®
  • Darzalex Faspro®
Legemiddel: Dexamethasone

Administered per the protocol

Andre navn:
  • Dexahexal®
Legemiddel: Pomalidomide

Administered per the protocol

Andre navn:
  • Pomalyst®
  • Imnovid®
Legemiddel: Bortezomib

Administered per the protocol

Andre navn:
  • Velcade®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Regeneron Pharmaceuticals

Etterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. januar 2026

Primær fullføring (Antatt)

21. mai 2029

Studiet fullført (Antatt)

23. august 2034

Datoer for studieregistrering

Først innsendt

28. oktober 2025

Først innsendt som oppfylte QC-kriteriene

28. oktober 2025

Først lagt ut (Faktiske)

30. oktober 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere