TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma in RelapseRefractory Multiple Myeloma
- Interventions
- Registration Number
- NCT03860038
- Lead Sponsor
- TJ Biopharma Co., Ltd.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TJ202 TJ202 and Dexamethasone -
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) end of study [ Time Frame: Approximately up to 2 years ] defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) end of study [ Time Frame: Approximately up to 2 years ] Time to response (TTR) end of study [ Time Frame: Approximately up to 2 years ] Time to progression (TTP) end of study [ Time Frame: Approximately up to 2 years ] Duration of response (DOR) end of study [ Time Frame: Approximately up to 2 years ] Clinical benefit rate (CBR) end of study [ Time Frame: Approximately up to 2 years ] Overall survival (OS) end of study [ Time Frame: Approximately up to 2 years ]
Related Research Topics
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Trial Locations
- Locations (18)
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
Scroll for more (8 remaining)Beijing Chao-Yang Hospital,Capital medical university🇨🇳Beijing, Beijing, China