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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
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
2034-08-23
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
Linvoseltamab
Administered per the protocol
Carfilzomib
Administered per the protocol
Daratumumab
Administered per the protocol
Dexamethasone
Administered per the protocol
Pomalidomide
Administered per the protocol
Bortezomib
Administered per the protocol
Locations (39)
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