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| Name | Class |
|---|---|
| Changshu Frist People's Hospital | UNKNOWN |
| The Second People's Hospital of Huai'an | OTHER |
| Affiliated Hospital of Jiangnan University | OTHER |
| Jiangsu Province Hospital of Traditional Chinese Medicine |
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The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients
This is a phase 3, single arm, multi-center study. The patients will receive BiRd regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous BCMA-directed CAR T-cells in newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BiRd combined with BCMA CAR T-cells infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, respectively, after counting ≥100 plasma cells). Complete Response (CR):negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Very good partial response (VGPR):serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 h. Partial response (PR): ≥50% reduction of serum M-protein plus reduction in 24 h urine M-protein by ≥90% or to <200 mg per 24 h. | 4 weeks after CAR T-cells infusion (up to 14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | time from enrollment to the date of death from any cause | 4 years |
| Event-free survival (EFS) | time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowen Tang, Ph.D | Contact | 86-512677801856 | xwtang1020@163.com | |
| Depei Wu, Ph.D | Contact | 86-512677801856 | drwudepei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaowen Tang, Ph.D | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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| OTHER |
| Jiangyin People's Hospital | OTHER |
| Jingjiang People's Hospital | OTHER |
| The Third People's Hospital of Kunshan | UNKNOWN |
| Lianyungang Hospital Affiliated Bengbu Medical College | OTHER |
| Suzhou Municipal Hospital | OTHER |
| Zhangjiagang First People's Hospital | OTHER |
| Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | INDUSTRY |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| Nanjing Medical University | OTHER |
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|
| 4 years |
| Cumulative incidence of relapse(CIR) | time from the date of achievement of a remission until the date of relapse | 4 years |
| Number of adverse events | adverse events are evaluated with CTCAE V5.0 | 2 years |
| 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 |
|---|---|
| D017291 | Clarithromycin |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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