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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
| Peking University People's Hospital | OTHER |
| Air Force Military Medical University, China | OTHER |
| Xiangya Hospital of Central South University |
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The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
Multiple myeloma (MM) is a malignant tumor with abnormal proliferation of monoclonal plasma cells in bone marrow. Bone damage is one of the characteristic clinical manifestations. Myeloma plasma cells and bone marrow microenvironment are the targets of thalidomide and bortezomib. The regimens based on them as first-line treatments of MM have greatly improved efficacy and prolonged the survival of MM patients. But whether the regimens can prevent and treat bone complications of MM patients or improve the quality of life is not clear. By evaluating the efficacy of PAD-regimen(Bortezomib,Pirarubicin and Dexamethasone) and TAD-regimen(Thalidomide,Pirarubicin and Dexamethasone) in MM and the effect of them on bone lesions, this study can provide evidence of evidence-based medicine for MM treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAD | Experimental |
| |
| TAD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib,Pirarubicin,Dexamethasone | Drug | Bortezomib:1.3mg/m2,on day 1,4,8 and 11 of each 28 day cycle; Pirarubicin:10mg,on day 1 to 4 of each 28 day cycle; Dexamethasone:20mg,on day 1 to 4 and 8 to 11 of each 28 day cycle; Number of cycles: up to 8 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria | every treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| The concentrations of bone metabolites | every two cycles | |
| chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method | at baseline | |
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Inclusion Criteria:
PLT≥50×109/L, Hb≥70 g/L, ANC≥0.75×109/L
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Hou, PhD | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Recruiting | Shanghai | Shanghai Municipality | 200003 | 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 |
|---|---|
| D000069286 | Bortezomib |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| OTHER |
| Institute of Hematology & Blood Diseases Hospital, China | OTHER |
| Union hospital of Fujian Medical University | OTHER |
| Harbin Hematology and Oncology Institute | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Beijing Jishuitan Hospital | OTHER |
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| Thalidomide,Pirarubicin,Dexamethasone | Drug | Thalidomide:200mg/d, everyday; Pirarubicin:10mg,on day 1 to 4 of each 28 day cycle; Dexamethasone:20mg,on day 1 to 4 and 8 to 11 of each 28 day cycle; Number of cycles: up to 8 cycles. |
|
| Overall survival(OS) and progression-free survival(FPS) |
| two and a half year |
| European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30) | every two cycles |
| 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 |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |