RecruitingPhase 1Phase 2NCT03761108

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

Phase 1/2 FIH Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) in Patients With Relapsed or Refractory Multiple Myeloma

Sponsor

Regeneron Pharmaceuticals

Enrollment

387 participants

Start Date

Jan 23, 2019

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

The main purpose of this study is to learn about the safety of linvoseltamab and to find out what is the best dose of linvoseltamab to give to patients with multiple myeloma and to look for any signs that linvoseltamab can effectively treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving linvoseltamab * How linvoseltamab works in the body * How much linvoseltamab is present in the blood * How linvoseltamab may work to treat cancer

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a drug called linvoseltamab, which targets cancer cells with a specific protein (BCMA), for people with multiple myeloma (a blood cancer) that has come back or stopped responding to other treatments. **You may be eligible if...** - You have been diagnosed with multiple myeloma (a cancer of the plasma cells in bone marrow) - Your myeloma has either returned (relapsed) or stopped responding to prior treatment (refractory) - You have already tried other available treatments - Your overall health is reasonably good (ECOG performance status 0–1) - Your organ function meets required thresholds **You may NOT be eligible if...** - You have never received prior treatment for multiple myeloma - You have had severe side effects from similar drugs in the past - You have active infections or certain autoimmune conditions - You are pregnant or breastfeeding - Your organ function is significantly impaired 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

Administered per the protocol

Locations(40)

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Moffitt Cancer Center - McKinley Drive

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Indiana University_Michigan Street

Indianapolis, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

C. S. Mott_University of Michigan

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Oregon Health and Science University (OHSU) Marquam Hill Campus

Portland, Oregon, United States

University of Texas MD Anderson Clinic

Houston, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

ZNA Psychiatrisch Ziekenhuis Stuivenberg

Antwerp, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitatsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR

Mainz, Rhineland-Palatinate, Germany

Universitatsklinikum Wurzburg

Würzburg, Germany

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Ibaraki Prefectural Central Hospital

Kasama-shi, Ibaraki, Japan

University Hospital Kyoto Prefectural Univ of Medicine

Kyoto, Kyoto, Japan

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Tokushima Prefectural Central Hospital

Tokushima, Tokushima, Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, Japan

Keio University Hospital

Tokyo, Japan

National Cancer Center Korea

Goyang, South Korea

Seoul National University Cancer Hospital

Seoul, South Korea

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

Seoul, South Korea

Yonsei University College of Medicine, Severance Hospital

Seoul, South Korea

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Universitary Hospital La Princesa

Madrid, Salamanca, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

View Full Details on ClinicalTrials.gov

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