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Spots Global Cancer Trial Database for Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

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Trial Identification

Brief Title: Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

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

Study ID: NCT03761108

Interventions

Linvoseltamab

Study Description

Brief Summary: The main purpose of this study is to learn about the safety of REGN5458 and to find out what is the best dose of REGN5458 to give to patients with multiple myeloma. An additional purpose is to look for any signs that REGN5458 can treat cancer. The study is looking at several other research questions, including: * Side effects that may be experienced by people receiving REGN5458 * How REGN5458 works in the body * How much REGN5458 is present in the blood * How REGN5458 may work to treat cancer

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Miami Hospital/Sylvester Comprehensive, Miami, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Norton Cancer Institute, Louisville, Kentucky, United States

University of Michigan Health System, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

The Icahn School of Medicine at Mount Sinai, New York, New York, United States

Columbia University Medical Center, Herbert Irving Pavilion, New York, New York, United States

The Ohio State University, James Cancer Hospital, Columbus, Ohio, United States

Oregon Health Science University OHSU, Portland, Oregon, United States

University of Texas MD Anderson Clinic, Houston, Texas, United States

Swedish Cancer Institute, Seattle, Washington, United States

Ziekenhuis Netwerk Antwerpen (ZNA)- Stuivenberg, Antwerp, , Belgium

Cliniques Universitaires Saint-Luc, Brussels, , Belgium

Universitaetsklinikum Essen, Essen, , Germany

University Medicine Mainz, Mainz, , Germany

Universitatsklinikum Wurzburg, Würzburg, , Germany

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital, Nagoya, Aichi, Japan

Nagoya City University Hospital, Nagoya, Aichi, Japan

Gunma University Hospital. 3-39-15 Showa-machi, Maebashi, Gunma, Japan

Saitama Medical University International Medical Center. 1397-1 Oaza Yamane, Hidaka, Hidaka, Saitama, Japan

Japanese Red Cross Medical Center. 4-1-22 Hiroo, Shibuya-ku, Tokyo, Japan

Ibaraki Prefectural Central Hospital. 6528 Koibuchi, Kasama, Kasama, , Japan

University Hospital Kyoto Prefectural University of Medicine. 465 Kajii-cho, Kawaramachi-Hirokoji,Kamigyo-ku, Kyoto, , Japan

Tokushima Prefectural Central Hospital. 1-10-3 Kuramoto-cho, Tokushima, , Japan

National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of

Soul National University Hospital Jongno-gu, Seoul, , Korea, Republic of

Severance Hospital, Yonsei University Health System Seodaemun-gu, Seoul, , Korea, Republic of

Seoul St.Mary's Hospital, The Catholic University of Korea Seocho-gu, Seoul, , Korea, Republic of

Clinica universidad de Navarra unidad centrak de ensayos clinicos 7a 2a fase, Pamplona, Navarre, Spain

Hospital Universitario Sant Pau, Carrer de Sant Antoni Maria Claret, 167, Barcelona, , Spain

Universitary Hospital La Princesa Calle de Diego de Leon 62, Madrid, , Spain

Hospital Universitario Ramon y Cajal M-607, km 9.100, Madrid, , Spain

Hospital 12 de Octubre Avda de Cordoba, s/n, Madrid, , Spain

Hospital Universitario de Salamanca Paseo de San Vicente 58-182, Salamanca, , Spain

The Royal Marsden Hospital Downs Road Surrey, London, , United Kingdom

Contact Details

Name: Clinical Trial Management

Affiliation: Regeneron Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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