Spots Global Cancer Trial Database for A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
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Trial Identification
Brief Title: A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Official Title: A PHASE 1B/2, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF ELRANATAMAB (PF-06863135) IN CHINESE PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY (TRIPLE-CLASS REFRACTORY MM)
Study ID: NCT05228470
Interventions
Study Description
Brief Summary: The purpose of this study is to understand the study medicine (called Elranatamab, or PF-06863135) as potential treatment for refractory multiple myeloma. Multiple myeloma is a form of cancer in the bone that forces healthy blood cells to go out. Sometimes, multiple myeloma does not respond to current therapy or quickly progresses, and this is called refractory multiple myeloma. Elranatamab is a study medicine that target multiple myeloma and activates the human body to fight against this disease. We are seeking Chinese participants to take part in this study. The study will be 2 parts, called part 1b and part 2. In part 1b, participants will receive Elranatamab at 2 steps priming and full dose as a sc (subcutaneous injection) therapy. We will monitor participants' safety and reactions to the study medicine. This will help us understand the dosage of Elranatamab to be used safely. In part 2 of the study, participants will receive Elranatamab and their multiple myeloma growth will be monitored. This will help us understand if Elranatamab, when used alone, may be a therapy for refractory multiple myeloma. Participants in this part of the study are expected to take part for about 2 years.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
Shenzhen Second People's Hosptial, Shenzhen, Guangdong, China
Harbin First Hospital, Harbin, Heilongjiang, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
Shandong Provincial Hospital, Jinan, Shandong, China
The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Beijing Boren Hospital, Beijing, , China
Beijing Gaobo Boren Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
Hematology Hospital, Chinese Academy of Medical Sciences, Tianjin, , China
Tianjin Medical University General Hospital, Tianjin, , China
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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