Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07222761

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)

Led by Regeneron Pharmaceuticals · Updated on 2026-05-08

915

Participants Needed

16

Research Sites

454 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult participants with relapsed or refractory Multiple Myeloma who have had at least 1 but no more than 3 prior treatments
  • Prior therapies must have included lenalidomide and either a Protease Inhibitor or an anti-CD38 monoclonal antibody
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
  • Confirmed disease progression during or after the most recent therapy according to IMWG criteria
Not Eligible

You will not qualify if you...

  • Prior treatment with T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), or Chimeric Antigen Receptor (CAR) T cells
  • Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia, or POEMS syndrome
  • Known Central Nervous System involvement of myeloma, including meningeal involvement
  • History of neurodegenerative conditions, Progressive Multifocal Leukoencephalopathy (PML), or central nervous system movement disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10021

Actively Recruiting

2

OhioHealth

Columbus, Ohio, United States, 43214

Actively Recruiting

3

Mater Misericordiae Ltd

Brisbane, Queensland, Australia, 4101

Actively Recruiting

4

Gold Coast Hospital and Health Service

Southport, Queensland, Australia, 4215

Actively Recruiting

5

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea, 58128

Actively Recruiting

6

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

7

Severance Hospital; Division of Hematology

Seoul, South Korea, 03722

Actively Recruiting

8

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

9

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

Seoul, South Korea, 06591

Actively Recruiting

10

Ulsan University Hospital

Ulsan, South Korea, 44033

Actively Recruiting

11

Aberdeen Royal Infirmary

Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN

Actively Recruiting

12

Royal Cornwall Hospital National Health Service (NHS) Foundation Trust

Truro, Cornwall, United Kingdom, TR1 3LJ

Actively Recruiting

13

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

Plymouth, Devon, United Kingdom, PL6 8DH

Actively Recruiting

14

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

Norwich, Norfolk, United Kingdom, NR4 7UY

Actively Recruiting

15

University Hospitals Birmingham NHS Trust, Center for Clinical

Birmingham, West Midlands, United Kingdom, B15 2GW

Actively Recruiting

16

Ninewells Hospital and Medical School

Dundee, United Kingdom, DD1 9SY

Actively Recruiting

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Research Team

C

Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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