Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05137054

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Led by Regeneron Pharmaceuticals · Updated on 2026-01-22

317

Participants Needed

42

Research Sites

631 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

CONDITIONS

Official Title

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Measurable multiple myeloma disease according to International Myeloma Working Group criteria
  • Adequate kidney, blood, and liver function as defined in the protocol
  • Life expectancy of at least 6 months
  • Relapsed or refractory multiple myeloma with progression after at least 3 prior therapies, or at least 2 prior therapies with specific prior drug exposures or refractory status as detailed in cohort criteria
  • Specific prior treatment and washout periods depending on cohort (e.g., anti-CD38 antibody, carfilzomib, lenalidomide, bortezomib, pomalidomide, isatuximab)
Not Eligible

You will not qualify if you...

  • Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (not myeloma-associated), Waldenström macroglobulinemia, or POEMS syndrome
  • Known brain lesions or meningeal involvement from multiple myeloma
  • Receiving systemic anti-myeloma therapy within 5 half-lives or 21 days before study drug
  • History of allogeneic or autologous stem cell transplant as defined
  • Prior treatment with BCMA-targeted T cell therapies (excluding antibody-drug conjugates)
  • History of progressive multifocal leukoencephalopathy, neurodegenerative or CNS movement disorders, or seizures in past 12 months
  • Live or attenuated vaccine within 28 days before study drug
  • Cardiac ejection fraction below 40%
  • Additional cohort-specific exclusions including peripheral neuropathy grade 2 or higher, malabsorption syndromes, prior immune therapies, autoimmune disease, organ transplants, and abnormal heart rhythm or drug interactions as detailed in protocol

AI-Screening

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Trial Site Locations

Total: 42 locations

1

Scripps Clinic Torrey Pines

La Jolla, California, United States, 92037

Actively Recruiting

2

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States, 30004

Actively Recruiting

3

Indiana University Health Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

4

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

5

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

6

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

7

Weill Cornell Medicine/New York Presbyterian Hospital

New York, New York, United States, 10021

Actively Recruiting

8

New York Presbyterian Hospital Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

9

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

10

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

11

The Ohio State University James Cancer Hospital

Columbus, Ohio, United States, 43210

Actively Recruiting

12

University of Texas Southwestern

Dallas, Texas, United States, 75390

Actively Recruiting

13

VA Puget Sound Health Care System

Seattle, Washington, United States, 98108

Actively Recruiting

14

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, New Aquitaine, France, 86021

Actively Recruiting

15

CHU de Lille - Rue Michel Polonovski

Lille, Nord, France, 59037

Suspended

16

Nantes University Hospital

Nantes, Pays de la Loire Region, France, 44093

Actively Recruiting

17

Centre Hospitalier Universitaire Angers

Angers, France, 49933

Actively Recruiting

18

CHU Montpellier - Departement D'Hematologie

Montpellier, France, 34295

Actively Recruiting

19

Saint Antoine Hospital

Paris, France, 75571

Actively Recruiting

20

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

21

Hospital Henri Mondor

Créteil, Île-de-France Region, France, 94000

Actively Recruiting

22

Saint Louis Hospital

Paris, Île-de-France Region, France, 75010

Actively Recruiting

23

Hopital Necker

Paris, Île-de-France Region, France, 75015

Actively Recruiting

24

Evangelismos General Hospital

Athens, Attica, Greece, 10676

Actively Recruiting

25

General Hospital of Athens Alexandra

Athens, Greece, 11528

Actively Recruiting

26

Sheba Medical Center

Ramat Gan, Central District, Israel, 5265601

Actively Recruiting

27

Rambam Health Care Campus

Haifa, Israel, 3109601

Actively Recruiting

28

Hadassah Medical Center

Jerusalem, Israel, 91120

Actively Recruiting

29

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruna, Spain, 15706

Actively Recruiting

30

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

31

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain, 39008

Actively Recruiting

32

Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, Spain, 28223

Actively Recruiting

33

Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

34

Hospital Universitario Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

35

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

36

Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals,

Barcelona, Spain, 08908

Actively Recruiting

37

Universitaru Hospital La Princesa

Madrid, Spain, 28006

Actively Recruiting

38

Clinica Universidad de Navarra - Madrid

Madrid, Spain, 28027

Actively Recruiting

39

Hospital Universitario Ramon y Cajal - Servicio de Psiquiatria

Madrid, Spain, 28034

Actively Recruiting

40

University Hospital and Research Institute

Madrid, Spain, 28041

Actively Recruiting

41

Hospital Universitario HM Sanchinarro

Madrid, Spain, 28050

Actively Recruiting

42

University Hospital of Salamanca

Salamanca, Spain, 37007

Actively Recruiting

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Research Team

C

Clinical Trials Administrator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

10

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