RecruitingPhase 3NCT07222761

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)

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

915 participants

Start Date

Jan 2, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two new treatment approaches against existing standard treatments for adults with multiple myeloma (a cancer of plasma cells in the bone marrow) that has come back or stopped responding to prior therapy. The new drug being tested, linvoseltamab, is an antibody that helps the immune system attack myeloma cells, and it is being tested both on its own and in combination with another drug called carfilzomib. **You may be eligible if...** - You are an adult with multiple myeloma that has relapsed or is no longer responding to treatment - You have received between 1 and 3 prior rounds of treatment, including lenalidomide and at least one other type of drug (a proteasome inhibitor or an anti-CD38 antibody) - You are still reasonably functional in daily activities (ECOG performance score of 2 or less) - Your myeloma is confirmed to be progressing based on standard lab criteria **You may NOT be eligible if...** - You have previously received an immune therapy that specifically targets a protein called BCMA (such as CAR T cells or bispecific T-cell engagers targeting BCMA) - You have plasma cell leukemia, amyloidosis, or a related plasma cell disorder - Your myeloma has spread to the brain or spinal fluid - You have a history of a brain movement disorder or progressive brain infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinvoseltamab

Administered per the protocol

DRUGCarfilzomib

Administered per the protocol

DRUGDaratumumab

Administered per the protocol

DRUGDexamethasone

Administered per the protocol

DRUGPomalidomide

Administered per the protocol

DRUGBortezomib

Administered per the protocol


Locations(14)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

OhioHealth

Columbus, Ohio, United States

Gold Coast Hospital and Health Service

Southport, Queensland, Australia

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital; Division of Hematology

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

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

Seoul, South Korea

Ulsan University Hospital

Ulsan, South Korea

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, United Kingdom

Royal Cornwall Hospital National Health Service (NHS) Foundation Trust

Truro, Cornwall, United Kingdom

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

Plymouth, Devon, United Kingdom

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

Norwich, Norfolk, United Kingdom

Ninewells Hospital and Medical School

Dundee, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07222761


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