RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07222761

Registry updated: 2026-10-08

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Description

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)

Interventions

Linvoseltamab (Drug)
Administered per the protocol
Carfilzomib (Drug)
Administered per the protocol
Daratumumab (Drug)
Administered per the protocol
Dexamethasone (Drug)
Administered per the protocol
Pomalidomide (Drug)
Administered per the protocol
Bortezomib (Drug)
Administered per the protocol

Eligibility criteria

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

Conditions

Relapsed and/or Refractory Multiple Myeloma (RRMM)

Locations

Emory Winship Cancer Institute — Atlanta, Georgia, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
OhioHealth — Columbus, Ohio, United States
Baylor University Medical Center — Dallas, Texas, United States
University of Texas Health Science Center, Houston — Houston, Texas, United States
Pindara Private Hospital — Benowa, Queensland, Australia
Mater Misericordiae Ltd — Brisbane, Queensland, Australia
Gold Coast Hospital and Health Service — Southport, Queensland, Australia
Alfred Hospital — Melbourne, Victoria, Australia
Royal Perth Hospital — Perth, Western Australia, Australia
Cetus Oncologia — Belo Horizonte, Minas Gerais, Brazil
Hospital Erasto Gaertner — Curitiba, Paraná, Brazil
Oncomed Clinica Oncologica — Niterói, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
Centro Gaucho Integrado, Hospital Mae de Deus — Porto Alegre, Rio Grande do Sul, Brazil
ANIMI — Lages, Santa Catarina, Brazil
Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo — Ribeirão Preto, São Paulo, Brazil
AC Camargo Cancer Center — São Paulo, Brazil
Hospital Clinico Universidad de Los Andes — Santiago, Las Condes, Chile
Clinica Alemana de Santiago — Santiago, Santiago Metropolitan, Chile
Clinica UC San Carlos de Apoquindo — Santiago, Santiago Metropolitan, Chile
OncoPrecision — Santiago, Santiago Metropolitan, Chile
Centro de Investigaciones Clinicas Vina del Mar — Viña del Mar, Valparaiso, Chile
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
Asan Medical Center — 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
Kaohsiung Medical University Hospital — Kaohsiung City, Taiwan
Taichung Veterans General Hospital — Taichung, Taiwan
National Taiwan University Hospital — Taipei, Taiwan
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
University Hospitals Birmingham NHS Trust, Center for Clinical — Birmingham, West Midlands, United Kingdom
Ninewells Hospital and Medical School — Dundee, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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