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Relapsed and/or Refractory Multiple Myeloma (RRMM)Phase 3LINKER-MM5NCT07222761

A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

A Phase 3 study testing Linvoseltamab, Carfilzomib and Daratumumab in people with Relapsed and/or Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 44 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Linvoseltamab, Carfilzomib and Daratumumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
915 participants
Where
44 sitesin 7 countries
Study dates
2 Jan 2026to 23 Aug 2034
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
  • Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Who cannot join

  • 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
  • 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)
  • Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
  • History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder
  • NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

44 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

44 sites in 7 countries

Brazil9 sites, 9 recruiting

  • Cetus Oncologia

    Belo Horizonte, Minas Gerais, 30110-022

    Recruiting

  • Hospital Erasto Gaertner

    Curitiba, Paraná, 81520-060

    Recruiting

  • ANIMI

    Lages, Santa Catarina, 88501-001

    Recruiting

  • Oncomed Clinica Oncologica

    Niterói, Rio de Janeiro, 24220-300

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

  • Centro Gaucho Integrado, Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90110-270

    Recruiting

  • Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo

    Ribeirão Preto, São Paulo, 14051-140

    Recruiting

  • AC Camargo Cancer Center

    São Paulo, 01509-010

    Recruiting

  • Clinica Medica Sao Germano

    São Paulo, 04537-080

    Recruiting

Other trials in Brazil

United Kingdom8 sites, 8 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen, Aberdeenshire, AB25 2ZN

    Recruiting

  • University Hospitals Birmingham NHS Trust, Center for Clinical

    Birmingham, West Midlands, B15 2GW

    Recruiting

  • Ninewells Hospital and Medical School

    Dundee, DD1 9SY

    Recruiting

  • University of Manchester, Manchester Royal Infirmary

    Manchester, M13 9WL

    Recruiting

  • Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust

    Norwich, Norfolk, NR4 7UY

    Recruiting

  • University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology

    Plymouth, Devon, PL6 8DH

    Recruiting

  • The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

    Recruiting

  • Royal Cornwall Hospital National Health Service (NHS) Foundation Trust

    Truro, Cornwall, TR1 3LJ

    Recruiting

Other trials in United Kingdom

South Korea7 sites, 7 recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Severance Hospital; Division of Hematology

    Seoul, 03722

    Recruiting

  • Asan Medical Center

    Seoul, 05505

    Recruiting

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    Seoul, 06591

    Recruiting

  • Ulsan University Hospital

    Ulsan, 44033

    Recruiting

Other trials in South Korea

Australia6 sites, 6 recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4211

    Recruiting

  • Mater Misericordiae Ltd

    Brisbane, Queensland, 4101

    Recruiting

  • Austin Hospital

    Heidelberg, Victoria, 3084

    Recruiting

  • Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Royal Perth Hospital

    Perth, Western Australia, 6000

    Recruiting

  • Gold Coast Hospital and Health Service

    Southport, Queensland, 4215

    Recruiting

Other trials in Australia

United States5 sites, 5 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Recruiting

  • OhioHealth

    Columbus, Ohio, 43214

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • University of Texas Health Science Center, Houston

    Houston, Texas, 77030

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

    Recruiting

Other trials in United States

Chile5 sites, 5 recruiting

  • Hospital Clinico Universidad de Los Andes

    Santiago, Las Condes, 7620157

    Recruiting

  • Clinica Alemana de Santiago

    Santiago, Santiago Metropolitan, 6681920

    Recruiting

  • Clinica UC San Carlos de Apoquindo

    Santiago, Santiago Metropolitan, 7550000

    Recruiting

  • OncoPrecision

    Santiago, Santiago Metropolitan, 7560908

    Recruiting

  • Centro de Investigaciones Clinicas Vina del Mar

    Viña del Mar, Valparaiso, 2540488

    Recruiting

Other trials in Chile

Taiwan4 sites, 4 recruiting

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80756

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Recruiting

  • National Taiwan University Hospital

    Taipei, 106

    Recruiting

  • Taipei Municipal Wan Fang Hospital

    Taipei, 116

    Recruiting

Other trials in Taiwan

About this study

Official title: An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

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.

Read more

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)
Being tested
Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Keywords
BCMA X CD3 Bispecific Monoclonal Antibody, Bispecific combination therapy, Linvoseltamab, Carfilzomib, Proteasome inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LinvoseltamabDrug

    Also called REGN5458, Lynozyfic™

    Administered per the protocol

  • CarfilzomibDrug

    Also called Kyprolis®

    Administered per the protocol

  • DaratumumabDrug

    Also called Darzalex Faspro®, Darzalex®

    Administered per the protocol

  • DexamethasoneDrug

    Also called Dexahexal®

    Administered per the protocol

  • PomalidomideDrug

    Also called Imnovid®, Pomalyst®

    Administered per the protocol

  • BortezomibDrug

    Also called Velcade®

    Administered per the protocol

Study groups in NCT07222761
Study groupRoleWhat they receive
Part 1: Arm AExperimentalNot described
Receives: Drug: Linvoseltamab
Part 1: Arm BExperimentalNot described
Receives: Drug: Linvoseltamab; Drug: Carfilzomib
Part 2: Arm AExperimentalNot described
Receives: Drug: Linvoseltamab
Part 2: Arm BExperimentalNot described
Receives: Drug: Linvoseltamab; Drug: Carfilzomib
Part 2: Arm CExperimentalNot described
Receives: Drug: Carfilzomib; Drug: Daratumumab; Drug: Dexamethasone; Drug: Pomalidomide; Drug: Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Part 1

    Measured: Up to 5 years

  2. Severity of TEAEs

    Part 1

    Measured: Up to 5 years

  3. Occurrence of Adverse Events of Special Interest (AESI)

    Part 1

    Measured: Up to 5 years

  4. Severity of AESIs

    Part 1

    Measured: Up to 5 years

  5. Occurrence of Serious Adverse Events (SAEs)

    Part 1

    Measured: Up to 5 years

  6. Severity of SAEs

    Part 1

    Measured: Up to 5 years

  7. Minimal Residual Disease (MRD)-negative Complete Response (CR)

    Part 2

    Measured: At 12 months

  8. Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC

    Part 2

    Measured: Up to 5 years

Secondary outcomes (36)

  1. Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)

    Part 1

    Measured: Up to 28 days

  2. Timing of grade ≥2 CRS

    Part 1

    Measured: Up to 28 days

  3. Overall Survival (OS)

    Part 2

    Measured: Up to 7 years

  4. Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC

    Part 2

    Measured: Up to 5 years

  5. Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC

    Part 2

    Measured: Up to 5 years

  6. Achievement of CR or better per IMWG response criteria as determined by BIRC

    Part 2

    Measured: Up to 5 years

  7. Duration Of Response (DOR) as per IMWG response criteria

    Part 2

    Measured: Up to 5 years

  8. Time To Progression (TTP) as per IMWG response criteria

    Part 2

    Measured: Up to 5 years

  9. Time To Next Treatment (TTNT)

    Part 2

    Measured: Up to 5 years

  10. Second PFS

    Part 2

    Measured: Up to 5 years

  11. MRD-negative CR criteria at any time

    Part 2

    Measured: Up to 5 years

  12. Time to PR IMWG response category

    Part 2

    Measured: Up to 5 years

  13. Time to VGPR IMWG response category

    Part 2

    Measured: Up to 5 years

  14. Time to CR IMWG response category

    Part 2

    Measured: Up to 5 years

  15. Time to stringent Complete Response (sCR) IMWG response category

    Part 2

    Measured: Up to 5 years

  16. Sustained MRD-negative CR

    Part 2

    Measured: Up to 5 years

  17. Duration of MRD-negative CR

    Part 2

    Measured: Up to 5 years

  18. Occurrence of TEAEs

    Part 2

    Measured: Up to 5 years

  19. Severity of TEAEs

    Part 2

    Measured: Up to 5 years

  20. Occurrence of AESIs

    Part 2

    Measured: Up to 5 years

  21. Severity of AESIs

    Part 2

    Measured: Up to 5 years

  22. Occurrence of SAEs

    Part 2

    Measured: Up to 5 years

  23. Severity of SAEs

    Part 2

    Measured: Up to 5 years

  24. Concentrations of linvoseltamab in serum over time

    Part 2

    Measured: Up to 5 years

  25. Incidence of Antidrug Antibodies (ADAs) to linvoseltamab

    Part 2

    Measured: Up to 5 years

  26. Magnitude of ADAs to linvoseltamab

    Part 2

    Measured: Up to 5 years

  27. Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time

    Part 2

    Measured: Up to 5 years

  28. 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)

    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."

    Measured: Up to 5 years

  29. Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30

    Part 2

    Measured: Up to 5 years

  30. Change from baseline in Role Functioning (RF), per EORTC QLQ-C30

    Part 2

    Measured: Up to 5 years

  31. Change from baseline in pain, per EORTC QLQ-C30

    Part 2

    Measured: Up to 5 years

  32. Change from baseline in fatigue, per EORTC QLQ-C30

    Part 2

    Measured: Up to 5 years

  33. Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])

    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.

    Measured: Up to 5 years

  34. Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20

    Part 2

    Measured: Up to 5 years

  35. Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)

    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.

    Measured: Up to 5 years

  36. Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5

    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)

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2025
  2. Study start2 Jan 2026
  3. Primary completion21 May 2029 (estimated)
  4. Study completion23 Aug 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
915 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07222761
Sponsor's protocol ID
R5458-ONC-2246
Other IDs
2024-519504-27-00
Acronym
LINKER-MM5
Status last verified
Oct 2026
First submitted
28 Oct 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

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