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)

NCT07222761 · tracked via the Priya Life Science UK tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Phase 3

Started

2026-01-02

Last updated

2026-10-21

Condition(s) studied

Relapsed and/or Refractory Multiple Myeloma (RRMM)

Investigational drug(s) / intervention(s)

Linvoseltamab →Carfilzomib →Daratumumab →Dexamethasone →Pomalidomide →Bortezomib →

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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Occurrence of Treatment Emergent Adverse Events (TEAEs) — Up to 5 years
Part 1
Severity of TEAEs — Up to 5 years
Part 1
Occurrence of Adverse Events of Special Interest (AESI) — Up to 5 years
Part 1
Severity of AESIs — Up to 5 years
Part 1
Occurrence of Serious Adverse Events (SAEs) — Up to 5 years
Part 1
Severity of SAEs — Up to 5 years
Part 1
Minimal Residual Disease (MRD)-negative Complete Response (CR) — At 12 months
Part 2
Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC — Up to 5 years
Part 2

Trial sites (44)

Facility	City	Region	Status
Emory Winship Cancer Institute	Atlanta	Georgia	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	Recruiting
OhioHealth	Columbus	Ohio	Recruiting
Baylor University Medical Center	Dallas	Texas	Recruiting
University of Texas Health Science Center, Houston	Houston	Texas	Recruiting
Pindara Private Hospital	Benowa	Queensland	Recruiting
Mater Misericordiae Ltd	Brisbane	Queensland	Recruiting
Gold Coast Hospital and Health Service	Southport	Queensland	Recruiting
Austin Hospital	Heidelberg	Victoria	Recruiting
Alfred Hospital	Melbourne	Victoria	Recruiting
Royal Perth Hospital	Perth	Western Australia	Recruiting
Cetus Oncologia	Belo Horizonte	Minas Gerais	Recruiting
Hospital Erasto Gaertner	Curitiba	Paraná	Recruiting
Oncomed Clinica Oncologica	Niterói	Rio de Janeiro	Recruiting
Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul	Recruiting
Centro Gaucho Integrado, Hospital Mae de Deus	Porto Alegre	Rio Grande do Sul	Recruiting
ANIMI	Lages	Santa Catarina	Recruiting
Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo	Ribeirão Preto	São Paulo	Recruiting
AC Camargo Cancer Center	São Paulo	Brazil	Recruiting
Clinica Medica Sao Germano	São Paulo	Brazil	Recruiting
Hospital Clinico Universidad de Los Andes	Santiago	Las Condes	Recruiting
Clinica Alemana de Santiago	Santiago	Santiago Metropolitan	Recruiting
Clinica UC San Carlos de Apoquindo	Santiago	Santiago Metropolitan	Recruiting
OncoPrecision	Santiago	Santiago Metropolitan	Recruiting
Centro de Investigaciones Clinicas Vina del Mar	Viña del Mar	Valparaiso	Recruiting
Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do	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
Taipei Municipal Wan Fang Hospital	Taipei	Taiwan	Recruiting
Aberdeen Royal Infirmary	Aberdeen	Aberdeenshire	Recruiting
Royal Cornwall Hospital National Health Service (NHS) Foundation Trust	Truro	Cornwall	Recruiting
University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology	Plymouth	Devon	Recruiting
Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust	Norwich	Norfolk	Recruiting

+ 4 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07222761 on ClinicalTrials.gov ↗ ← All trials in the UK