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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR