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NCT07222761PHASE3Recruiting

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)

Regeneron Pharmaceuticals

Start Date

1/2/2026

Completion Date

8/23/2034

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Linvoseltamab

DRUG

Carfilzomib

DRUG

Daratumumab

DRUG

Dexamethasone

DRUG

Pomalidomide

DRUG

Bortezomib

Interested in This Trial?

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Conditions

Relapsed and/or Refractory Multiple Myeloma (RRMM)

Locations

Emory Winship Cancer Institute

Atlanta, Georgia 30322

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

OhioHealth

Columbus, Ohio 43214

United States

University of Texas Health Science Center, Houston

Houston, Texas 77030

United States

Mater Misericordiae Ltd

Brisbane, Queensland 4101

Australia

Gold Coast Hospital and Health Service

Southport, Queensland 4215

Australia

Alfred Hospital

Melbourne, Victoria 3004

Australia

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do 58128

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital; Division of Hematology

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

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

Seoul, 06591

South Korea

Ulsan University Hospital

Ulsan, 44033

South Korea

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire AB25 2ZN

United Kingdom

Royal Cornwall Hospital National Health Service (NHS) Foundation Trust

Truro, Cornwall TR1 3LJ

United Kingdom

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

Plymouth, Devon PL6 8DH

United Kingdom

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

Norwich, Norfolk NR4 7UY

United Kingdom

University Hospitals Birmingham NHS Trust, Center for Clinical

Birmingham, West Midlands B15 2GW

United Kingdom

Ninewells Hospital and Medical School

Dundee, DD1 9SY

United Kingdom