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A Study of Elranatamab (PF-06863135) in Chinese Participants With Refractory Multiple Myeloma.
Sponsor: Pfizer
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
39
Start Date
2021-12-21
Completion Date
2025-09-11
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Elranatamab
BCMA-CD3 bispecific antibody
Locations (15)
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
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 First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 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