Status:
COMPLETED
TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
TJ Biopharma Co., Ltd.
Conditions:
Multiple Myeloma in Relapse
Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rece...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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;
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2023
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT03860038
Start Date
January 28 2019
End Date
January 28 2023
Last Update
April 24 2025
Active Locations (18)
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1
Beijing Chao-Yang Hospital,Capital medical university
Beijing, Beijing Municipality, China
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
3
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
4
Nanfang Hospital of SMU
Guangzhou, Guandong, China