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| Name | Class |
|---|---|
| 307 Hospital of PLA | OTHER |
Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma.
NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT, were randomly divided into two arms. One arm receive microtransplantation, and the other accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were also been observed. Clear the above program related hematopoietic recovery, remission rate, infection and recurrence rate, survival rate and the formation of micro inlay, minimal residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment of multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-SCT | Active Comparator | patients treated with microtransplantation. [VMD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; melphalan 60mg/m2 d1; dexamethasone 20mg d1,2,4,5,8,9,11,12) + low dose allogeneic stem cell transplantation]×4cycles; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×1cycle; then maintenance therapy with thalidomide 100mg/d. microtransplantation = [VMD regimen chemotherapy+ low dose allogeneic stem cell transplantation]×4cycles |
|
| Auto-SCT | Active Comparator | patients treated with Auto-SCT. conditioning with Mel+Vel regimen (melphalan 200mg/m2 d-2, bortezomib 1.3mg/m2 d-6,-3,+1,+4) + autogeneic stem cell transplantation; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×4cycle; then maintenance therapy with thalidomide 100mg/d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell transplantation | Procedure | conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 2 years | |
| overall survival | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| rate of complete remission | 2 year | |
| minimal residual disease | 2 year | |
| hematopoietic recovery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guorong Wang, doctor | Contact | +861085231572 | blunlake@163.com | |
| Wenming Chen, doctor | Contact | +8685231581 | wenming_chen@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenming Chen, doctor | Beijing Chao Yang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 3 month |
| infection | 3 month |
| GVHD | 1 year |
| relapse | 2 year |
| 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 |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |