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A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
Sponsor: Regeneron Pharmaceuticals
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)
Official title: Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
317
Start Date
2022-08-17
Completion Date
2032-03-24
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
Linvoseltamab
Administered per the protocol
Daratumumab
Administered per the protocol
Carfilzomib
Administered per the protocol
Lenalidomide
Administered per the protocol
Bortezomib
Administered per the protocol
Pomalidomide
Administered per the protocol
Isatuximab
Administered per the protocol
Fianlimab
Administered per the protocol
Cemiplimab
Administered per the protocol
Nirogacestat
Administered per the protocol
Cevostamab
Administered per the protocol
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