RecruitingPhase 1NCT05137054

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

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma


Sponsor

Regeneron Pharmaceuticals

Enrollment

317 participants

Start Date

Aug 17, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests linvoseltamab — a new drug that connects immune cells directly to myeloma cancer cells — in combination with other treatments for people with multiple myeloma that has stopped responding to standard therapies. **You may be eligible if...** - You are in good overall health (ECOG 0–1) - You have measurable multiple myeloma - Your myeloma has relapsed or is resistant to current standard treatments - You have adequate kidney, blood, and liver function - Your life expectancy is at least 6 months **You may NOT be eligible if...** - Your myeloma cannot be measured - You have not received prior standard therapies - You have poor organ function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLinvoseltamab

Linvoseltamab is administered by intravenous (IV) infusion

DRUGDaratumumab

Daratumumab is administered by IV infusion and/or subcutaneous (SC) injection; SC injection may be used after a minimum of 2 cycles of IV administration at the investigator's discretion.

DRUGCarfilzomib

Carfilzomib is administered by IV infusion

DRUGLenalidomide

Lenalidomide is administered by mouth (PO) as a capsule

DRUGBortezomib

Bortezomib is administered by IV infusion or SC injection

DRUGPomalidomide

Pomalidomide is administered by mouth (PO) as a capsule

DRUGIsatuximab

Isatuximab is administered by IV infusion

DRUGFianlimab

Fianlimab is administered by IV infusion

DRUGCemiplimab

Cemiplimab is administered by IV infusion

DRUGNirogacestat

Nirogacestat is administered by mouth (PO) as a tablet

DRUGCevostamab

Cevostamab is administered by IV infusion


Locations(42)

Scripps Clinic Torrey Pines

La Jolla, California, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Indiana University Health Simon Cancer Center

Indianapolis, Indiana, United States

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Weill Cornell Medicine/New York Presbyterian Hospital

New York, New York, United States

New York Presbyterian Hospital Columbia University Medical Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

The Ohio State University James Cancer Hospital

Columbus, Ohio, United States

University of Texas Southwestern

Dallas, Texas, United States

VA Puget Sound Health Care System

Seattle, Washington, United States

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, New Aquitaine, France

CHU de Lille - Rue Michel Polonovski

Lille, Nord, France

Nantes University Hospital

Nantes, Pays de la Loire Region, France

Centre Hospitalier Universitaire Angers

Angers, France

CHU Montpellier - Departement D'Hematologie

Montpellier, France

Saint Antoine Hospital

Paris, France

Institut Gustave Roussy

Villejuif, France

Hospital Henri Mondor

Créteil, Île-de-France Region, France

Saint Louis Hospital

Paris, Île-de-France Region, France

Hopital Necker

Paris, Île-de-France Region, France

Evangelismos General Hospital

Athens, Attica, Greece

General Hospital of Athens Alexandra

Athens, Greece

Sheba Medical Center

Ramat Gan, Central District, Israel

Rambam Health Care Campus

Haifa, Israel

Hadassah Medical Center

Jerusalem, Israel

Hospital Clinico Universitario de Santiago

Santiago de Compostela, A Coruna, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Quiron Salud Madrid

Pozuelo de Alarcón, Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

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

Barcelona, Spain

Universitaru Hospital La Princesa

Madrid, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Universitario Ramon y Cajal - Servicio de Psiquiatria

Madrid, Spain

University Hospital and Research Institute

Madrid, Spain

Hospital Universitario HM Sanchinarro

Madrid, Spain

University Hospital of Salamanca

Salamanca, Spain

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