Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

En studie för att jämföra linvoseltamab-monoterapi och linvoseltamab + carfilzomib-kombinationsterapi med standardbehandlingskombinationsregimer hos vuxna deltagare med återfallande/refraktär multipelt myelom (RRMM) (LINKER-MM5)

3 november 2026 uppdaterad av: Regeneron Pharmaceuticals

En öppen, randomiserad fas 3-studie av linvoseltamab-monoterapi och linvoseltamab plus carfilzomib jämfört med standardbehandlingskombinationsregimer hos patienter med återfallande/refraktär multipelt myelom

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)

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

915

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Del 1: Arm A
Läkemedel: Linvoseltamab

Administered per the protocol

Andra namn:
  • REGN5458
  • Lynozyfic ™
Experimentell: Del 1: Arm B
Läkemedel: Linvoseltamab

Administered per the protocol

Andra namn:
  • REGN5458
  • Lynozyfic ™
Läkemedel: Carfilzomib

Administered per the protocol

Andra namn:
  • Kyprolis®
Experimentell: Del 2: Arm A
Läkemedel: Linvoseltamab

Administered per the protocol

Andra namn:
  • REGN5458
  • Lynozyfic ™
Experimentell: Del 2: Arm B
Läkemedel: Linvoseltamab

Administered per the protocol

Andra namn:
  • REGN5458
  • Lynozyfic ™
Läkemedel: Carfilzomib

Administered per the protocol

Andra namn:
  • Kyprolis®
Experimentell: Del 2: Arm C
Läkemedel: Carfilzomib

Administered per the protocol

Andra namn:
  • Kyprolis®
Läkemedel: Daratumumab

Administered per the protocol

Andra namn:
  • Darzalex®
  • Darzalex Faspro®
Läkemedel: Dexamethasone

Administered per the protocol

Andra namn:
  • Dexahexal®
Läkemedel: Pomalidomide

Administered per the protocol

Andra namn:
  • Pomalyst®
  • Imnovid®
Läkemedel: Bortezomib

Administered per the protocol

Andra namn:
  • Velcade®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsram: Up to 5 years

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

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

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

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

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

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

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

Part 2
Up to 5 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)
Tidsram: Up to 28 days

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

Part 1
Up to 28 days
Overall Survival (OS)
Tidsram: 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
Tidsram: 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
Tidsram: Up to 5 years

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Regeneron Pharmaceuticals

Utredare

  • Studierektor: Clinical Trial Management, Regeneron Pharmaceuticals

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 januari 2026

Primärt slutförande (Beräknad)

21 maj 2029

Avslutad studie (Beräknad)

23 augusti 2034

Studieregistreringsdatum

Först inskickad

28 oktober 2025

Först inskickad som uppfyllde QC-kriterierna

28 oktober 2025

Första postat (Faktisk)

30 oktober 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera