Back to resultsTJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma in Relapse, Refractory Multiple Myeloma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TJ202 and Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma in Relapse
Eligibility Criteria
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.
Sites / Locations
- Beijing Chao-Yang Hospital,Capital medical university
- Peking Union Medical College Hospital
- Fujian Medical University Union Hospital
- Nanfang Hospital of SMU
- The second people's Hospital of Shenzhen
- Sun Yat-sen University Cancer Center
- Henan Cancer Hospital
- Jiangsu Province Hospital
- The first Bethune hospital of Jilin University
- Shanghai Changzheng Hospital
- National Taiwan University Hospital
- Tri-Service General Hospital
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
- Tianjin Medical University Cancer Institute and Hospital
- Tianjin Medical University General Hospital
- Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine
- The First Affiliated Hospital, College of Medicine,Zhejiang University
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TJ202
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Time to progression (TTP)
Time to response (TTR)
Progression-free survival (PFS)
Overall survival (OS)
Full Information
NCT ID
NCT03860038
First Posted
January 15, 2019
Last Updated
September 10, 2023
Sponsor
I-Mab Biopharma Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03860038
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
January 28, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I-Mab Biopharma Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma in Relapse, Refractory Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TJ202
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TJ202 and Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Secondary Outcome Measure Information:
Title
Clinical benefit rate (CBR)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Title
Duration of response (DOR)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Title
Time to progression (TTP)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Title
Time to response (TTR)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Title
Progression-free survival (PFS)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Title
Overall survival (OS)
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
Other Pre-specified Outcome Measures:
Title
minimal residual disease (MRD) assessment
Description
For subjects reaching CR and above, their bone marrow samples will be collected for exploratory minimal residual disease (MRD) assessment at the central laboratory.
Time Frame
end of study [ Time Frame: Approximately up to 2 years ]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, Doctor
Organizational Affiliation
Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital,Capital medical university
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Nanfang Hospital of SMU
City
Guangzhou
State/Province
Guandong
Country
China
Facility Name
The second people's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangzhou
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The first Bethune hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
National Taiwan University Hospital
City
Taiwan
State/Province
Taiwan
Country
China
Facility Name
Tri-Service General Hospital
City
Taiwan
State/Province
Taiwan
Country
China
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Sir Run Run Shaw Hospital，affiliated with the Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital, College of Medicine,Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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