> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-compare-linvoseltamab-monotherapy-and-dbc739bf-f146-455a-a199-9e31a00206ef > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) Participants 915 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) Start date 2026-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) Number of sites 44 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Acronym** LINKER-MM5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Dates **Completion date** 2034-08-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **First posted** 2025-10-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Registry last updated** 2026-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Primary completion date** 2029-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Start date** 2026-01-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Size and sites **Participants** 915 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Planned participants** 915 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Number of sites** 44 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Identifiers **Registry ID** NCT07222761 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **ClinicalTrials.gov ID** NCT07222761 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Eligibility **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## References ### Other registry identifiers - 2024-519504-27-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07222761) ## Related records ### Drugs (6) - [Bortezomib](https://trialight.com/data/asset/bortezomib-35a853cf-26ab-4a4c-a405-ae671d364aad.md) - [Carfilzomib](https://trialight.com/data/asset/carfilzomib-42f49602-1f34-4e14-b345-79d6fd69324f.md) - [Daratumumab](https://trialight.com/data/asset/daratumumab-28c327e5-1741-4dd5-89d4-6562e941ab50.md) - [Dexamethasone](https://trialight.com/data/asset/dexamethasone-b923ddae-f095-408c-96e9-975238a429ad.md) - [Linvoseltamab](https://trialight.com/data/asset/linvoseltamab-ce410b5b-5456-425a-8d0a-3924dff79a86.md) - [Pomalidomide](https://trialight.com/data/asset/pomalidomide-8cab22f9-2d15-4e50-9ef9-334f56340121.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (1) - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Primary condition ### Targets (47) - [ADRM1](https://trialight.com/data/target/adrm1-21aacba2-e414-54a6-9f55-4bf543c44c62.md) - [CD38](https://trialight.com/data/target/cd38-a5ca1a53-c2f5-5b8e-9449-680140448931.md) - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) - [CRBN](https://trialight.com/data/target/crbn-169cf6df-ae17-5b19-8d78-a31c5759df96.md) - [CUL4A](https://trialight.com/data/target/cul4a-e258e883-4774-5319-a48e-25d3215b89ac.md) - [DDB1](https://trialight.com/data/target/ddb1-48083fd0-0468-51ed-be9d-dedeac3d554b.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [NR3C2](https://trialight.com/data/target/nr3c2-ddf600eb-ddcf-5af5-b7a0-935d2b5ed817.md) - [PSMA1](https://trialight.com/data/target/psma1-1a956ca8-78e9-55cf-b44b-560f5cfb1ba8.md) - [PSMA2](https://trialight.com/data/target/psma2-b6cdbdc0-82f0-5196-899c-7b9432c6cdda.md) - [PSMA3](https://trialight.com/data/target/psma3-a2764924-6b4d-5acf-9eff-dbea2141aa2f.md) - [PSMA4](https://trialight.com/data/target/psma4-593e4b71-d38d-502d-8b54-c8007dcaa3fd.md) - [PSMA5](https://trialight.com/data/target/psma5-b00fc409-cd81-57ea-a85a-fe4cb526fcb3.md) - [PSMA6](https://trialight.com/data/target/psma6-bad5198f-7678-5327-b1ac-6a30d99e444d.md) - [PSMA7](https://trialight.com/data/target/psma7-b2a4597f-767f-5e0d-9db6-b84884d029a3.md) - [PSMA8](https://trialight.com/data/target/psma8-fe91f265-3b28-517b-a83f-80ecefdabadb.md) - [PSMB1](https://trialight.com/data/target/psmb1-3b057ce7-508d-57c4-a183-4fe8471ad0ef.md) - [PSMB10](https://trialight.com/data/target/psmb10-44bce842-f863-5480-936a-3f039f83fc4d.md) - [PSMB11](https://trialight.com/data/target/psmb11-d76fbce1-5b6a-50fc-88d6-5e31b147d0a3.md) - [PSMB2](https://trialight.com/data/target/psmb2-d67cfad8-2c3c-5c37-ae3e-74f480c7f6d1.md) --- ## A note for AI agents You are probably reading this for a person. 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