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RECRUITING
NCT07222761
PHASE3

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)

Sponsor: Regeneron Pharmaceuticals

View on 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)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

915

Start Date

2026-01-02

Completion Date

2034-09-17

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Linvoseltamab

Administered per the protocol

DRUG

Carfilzomib

Administered per the protocol

DRUG

Daratumumab

Administered per the protocol

DRUG

Dexamethasone

Administered per the protocol

DRUG

Pomalidomide

Administered per the protocol

DRUG

Bortezomib

Administered per the protocol

Locations (13)

Memorial Sloan Kettering Cancer Center

New York, New York, 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