Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Study of Efficacy of PAD-regimen(Bortezomib,Pirarubicin and Dexamethasone) and TAD-regimen(Thalidomide,Pirarubicin and Dexamethasone) in Newly Diagnosed Multiple Myeloma,Influence in Concentration of Bone Metabolites,and the Relations With Different Cytogenetic and Molecular Biological Changes

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Bortezomib,Pirarubicin,Dexamethasone
* Drug: Thalidomide,Pirarubicin,Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with symptomatic and measurable newly diagnosed Multiple Myeloma. Age > 18 years, KPS ≥ 60, and life expectancy of at least 3 months. Subjects must meet all of the following criteria within 14 days before starting therapy: PLT≥50×109/L, Hb≥70 g/L, ANC≥0.75×109/L Subjects (or their legally acceptable representatives) must signed an informed consent document. Exclusion Criteria: Severe cardiovascular disease ; HIV infection, or positive HBsAg, or active hepatitis C; HBV-DNA>104; hepatic functional parameter>2.5 times the upper limit of institutional laboratory normal. Grade 2 or more severe peripheral neuropathy or neuropathic pain; Grade 2 or more severe impaired hepatic and kidney function. Patient has radiotherapy or major surgery within 30 days before enrollment. Patient has hypersensitivity to boron, mannitol or thalidomide. Pregnant or breastfeeding women, or subject unwilling to use a method for contraception during the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAD<br> | Drug: Bortezomib,Pirarubicin,Dexamethasone<br>* 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.<br>|
| Experimental: TAD<br> | Drug: Thalidomide,Pirarubicin,Dexamethasone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bortezomib,Thalidomide,bone metabolites