TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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
1 other identifier
interventional
113
2 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2019
Typical duration for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2019
CompletedStudy Start
First participant enrolled
January 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2023
CompletedApril 24, 2025
April 1, 2025
4 years
January 15, 2019
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
end of study [ Time Frame: Approximately up to 2 years ]
Secondary Outcomes (6)
Clinical benefit rate (CBR)
end of study [ Time Frame: Approximately up to 2 years ]
Duration of response (DOR)
end of study [ Time Frame: Approximately up to 2 years ]
Time to progression (TTP)
end of study [ Time Frame: Approximately up to 2 years ]
Time to response (TTR)
end of study [ Time Frame: Approximately up to 2 years ]
Progression-free survival (PFS)
end of study [ Time Frame: Approximately up to 2 years ]
- +1 more secondary outcomes
Other Outcomes (1)
minimal residual disease (MRD) assessment
end of study [ Time Frame: Approximately up to 2 years ]
Study Arms (1)
TJ202
EXPERIMENTALInterventions
one dose of TJ202 16 mg/kg or an adjusted dose will be administered on Day 1 and Day 4 of Week 1, then every week from Week 2 to Week 12, then every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter, until the subjects experience an onset of endpoint events like intolerance or PD. DEX 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.
Eligibility Criteria
You may qualify if:
- Age ≥ 18, male or female;
- Subject must have had documented MM;
- At screening phase, subject must have measurable disease;
- Subject is in a state of progressive disease (PD);
- Subject must have life expectancy of no less than 6 months;
- Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0\~2;
You may not qualify if:
- Subject has received anti-CD38 monoclonal antibody treatment previously;
- Subject has received CAR-T cell therapy previously;
- Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent;
- Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy);
- Subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or 5 PK half-lives of the treatment, whichever longer, before the first study agent administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Beijing Chao-Yang Hospital,Capital medical university
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 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 Municipality, 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 Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 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, 11217, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lugui Qiu, Doctor
Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2019
First Posted
March 1, 2019
Study Start
January 28, 2019
Primary Completion
January 28, 2023
Study Completion
January 28, 2023
Last Updated
April 24, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share