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Brief Title: TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title: A Phase 2, Multi-center, Single-arm Study of TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 2 Prior Lines of Treatment
Study ID: NCT03860038
Brief Summary: This trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.
Detailed Description: A total of 82 subjects with relapsed or refractory multiple myeloma (RRMM) who have received at least 2 prior lines of treatment will be enrolled in this study. Prior lines of treatment must include a proteasome inhibitor (PI) and an immunomodulator (IMiD). All subjects will receive TJ202 and dexamethasone (DEX) in the study. The treatment will continue until endpoint events such as intolerance or progressive disease (PD).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Chao-Yang Hospital,Capital medical university, Beijing, Beijing, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Fujian Medical University Union Hospital, Fuzhou, Fujian, China
Nanfang Hospital of SMU, Guangzhou, Guandong, China
The second people's Hospital of Shenzhen, Shenzhen, Guangdong, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangzhou, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
The first Bethune hospital of Jilin University, Changchun, Jilin, China
Shanghai Changzheng Hospital, Shanghai, Shanghai, China
National Taiwan University Hospital, Taiwan, Taiwan, China
Tri-Service General Hospital, Taiwan, Taiwan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, Tianjin, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
Sir Run Run Shaw Hospital,affiliated with the Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine,Zhejiang University, Hangzhou, Zhejiang, China
Taipei Veterans General Hospital, Taipei, , Taiwan
Name: Lugui Qiu, Doctor
Affiliation: Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
Role: PRINCIPAL_INVESTIGATOR