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)

NCT07222761
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
clinicaltrials.gov
Participants
915
clinicaltrials.gov
Lead sponsor
Regeneron Pharmaceuticals
clinicaltrials.gov
Start date
2026-01-02
clinicaltrials.gov
Number of sites
44
clinicaltrials.gov

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. 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)
clinicaltrials.gov
Acronym
LINKER-MM5
clinicaltrials.gov
Short title
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)
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Open label
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Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 3
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Study type
Interventional
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Completion date
2034-08-23
clinicaltrials.gov
First posted
2025-10-30
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Registry last updated
2026-10-21
clinicaltrials.gov
Primary completion date
2029-05-21
clinicaltrials.gov
Start date
2026-01-02
clinicaltrials.gov

Participants
915
clinicaltrials.gov
Participant count basis
Estimated
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Planned participants
915
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Protocol amendments
0
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Number of sites
44
clinicaltrials.gov

Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07222761
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07222761
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 5 years

    Part 1

  2. Severity of TEAEs

    Timeframe: Up to 5 years

    Part 1

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

    Timeframe: Up to 5 years

    Part 1

  4. Severity of AESIs

    Timeframe: Up to 5 years

    Part 1

  5. Occurrence of Serious Adverse Events (SAEs)

    Timeframe: Up to 5 years

    Part 1

  6. Severity of SAEs

    Timeframe: Up to 5 years

    Part 1

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

    Timeframe: At 12 months

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

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

    Timeframe: Up to 28 days

    Part 1

  2. Timing of grade ≥2 CRS

    Timeframe: Up to 28 days

    Part 1

  3. Overall Survival (OS)

    Timeframe: Up to 7 years

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

  9. Time To Next Treatment (TTNT)

    Timeframe: Up to 5 years

    Part 2

  10. Second PFS

    Timeframe: Up to 5 years

    Part 2

  11. MRD-negative CR criteria at any time

    Timeframe: Up to 5 years

    Part 2

  12. Time to PR IMWG response category

    Timeframe: Up to 5 years

    Part 2

  13. Time to VGPR IMWG response category

    Timeframe: Up to 5 years

    Part 2

  14. Time to CR IMWG response category

    Timeframe: Up to 5 years

    Part 2

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

    Timeframe: Up to 5 years

    Part 2

  16. Sustained MRD-negative CR

    Timeframe: Up to 5 years

    Part 2

  17. Duration of MRD-negative CR

    Timeframe: Up to 5 years

    Part 2

  18. Occurrence of TEAEs

    Timeframe: Up to 5 years

    Part 2

  19. Severity of TEAEs

    Timeframe: Up to 5 years

    Part 2

  20. Occurrence of AESIs

    Timeframe: Up to 5 years

    Part 2

  21. Severity of AESIs

    Timeframe: Up to 5 years

    Part 2

  22. Occurrence of SAEs

    Timeframe: Up to 5 years

    Part 2

  23. Severity of SAEs

    Timeframe: Up to 5 years

    Part 2

  24. Concentrations of linvoseltamab in serum over time

    Timeframe: Up to 5 years

    Part 2

  25. Incidence of Antidrug Antibodies (ADAs) to linvoseltamab

    Timeframe: Up to 5 years

    Part 2

And 11 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility
clinicaltrials.gov

  • Emory Winship Cancer InstituteAtlanta, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • OhioHealthColumbus, United StatesRecruiting
  • Baylor University Medical CenterDallas, United StatesRecruiting
  • University of Texas Health Science Center, HoustonHouston, United StatesRecruiting
  • Pindara Private HospitalBenowa, AustraliaRecruiting
  • Mater Misericordiae LtdBrisbane, AustraliaRecruiting
  • Gold Coast Hospital and Health ServiceSouthport, AustraliaRecruiting
  • Austin HospitalHeidelberg, AustraliaRecruiting
  • Alfred HospitalMelbourne, AustraliaRecruiting
  • Royal Perth HospitalPerth, AustraliaRecruiting
  • Cetus OncologiaBelo Horizonte, BrazilRecruiting
  • Hospital Erasto GaertnerCuritiba, BrazilRecruiting
  • Oncomed Clinica OncologicaNiterói, BrazilRecruiting
  • Hospital de Clinicas de Porto AlegrePorto Alegre, BrazilRecruiting
  • Centro Gaucho Integrado, Hospital Mae de DeusPorto Alegre, BrazilRecruiting
  • ANIMILages, BrazilRecruiting
  • Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao PauloRibeirão Preto, BrazilRecruiting
  • AC Camargo Cancer CenterSão Paulo, BrazilRecruiting
  • Clinica Medica Sao GermanoSão Paulo, BrazilRecruiting
  • Hospital Clinico Universidad de Los AndesSantiago, ChileRecruiting
  • Clinica Alemana de SantiagoSantiago, ChileRecruiting
  • Clinica UC San Carlos de ApoquindoSantiago, ChileRecruiting
  • OncoPrecisionSantiago, ChileRecruiting
  • Centro de Investigaciones Clinicas Vina del MarViña del Mar, ChileRecruiting

And 19 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-519504-27-00
Sources for references
clinicaltrials.gov

Related records

Drugs (6)

Lead sponsors (1)

Conditions (1)

Targets (47)