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
- Relapsed and/or Refractory Multiple Myeloma (RRMM)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Regeneron Pharmaceuticals
- Enrolment target
- 915
- Started
- 2 January 2026
- Main results due
- 21 May 2029
- Study sites
- 28
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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)
Study sites(28)
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recruiting
OhioHealth
Columbus, Ohio, United States
Recruiting
Baylor University Medical Center
Dallas, Texas, United States
Recruiting
University of Texas Health Science Center, Houston
Houston, Texas, United States
Recruiting
Pindara Private Hospital
Benowa, Queensland, Australia
Recruiting
Mater Misericordiae Ltd
Brisbane, Queensland, Australia
Recruiting
Gold Coast Hospital and Health Service
Southport, Queensland, Australia
Recruiting
Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Royal Perth Hospital
Perth, Western Australia, Australia
Recruiting
Centro Gaucho Integrado, Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
OncoPrecision
Santiago, Santiago Metropolitan, Chile
Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Severance Hospital; Division of Hematology
Seoul, South Korea
Recruiting
Asan Medical Center
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
Recruiting
Ulsan University Hospital
Ulsan, South Korea
Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan
Recruiting
National Taiwan University Hospital
Taipei, Taiwan
Recruiting
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, United Kingdom
Recruiting
Royal Cornwall Hospital National Health Service (NHS) Foundation Trust
Truro, Cornwall, United Kingdom
Recruiting
University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology
Plymouth, Devon, United Kingdom
Recruiting
Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust
Norwich, Norfolk, United Kingdom
Recruiting
University Hospitals Birmingham NHS Trust, Center for Clinical
Birmingham, West Midlands, United Kingdom
Recruiting
Ninewells Hospital and Medical School
Dundee, United Kingdom
Recruiting
Showing 28 of 28 sites. 28 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07222761. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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