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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ202 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ202 and Dexamethasone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ] |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ] | |
| Measure | Description | Time Frame |
|---|---|---|
| minimal residual disease (MRD) assessment | For subjects reaching CR and above, their bone marrow samples will be collected for exploratory minimal residual disease (MRD) assessment at the central laboratory. | end of study [ Time Frame: Approximately up to 2 years ] |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lugui Qiu, Doctor | Institute of Hematology & Hospital of Blood Diseases CAMS&PUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital,Capital medical university | Beijing | Beijing Municipality | China | |||
| Peking Union Medical College Hospital |
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|
| 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 ] |
| Overall survival (OS) | end of study [ Time Frame: Approximately up to 2 years ] |
| 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 |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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