Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
Recruitment status was Recruiting
The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria [ Time Frame: every treatment cycle ] [ Designated as safety issue: No ]
- The concentrations of bone metabolites [ Time Frame: every two cycles ] [ Designated as safety issue: No ]
- chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method [ Time Frame: at baseline ] [ Designated as safety issue: No ]
- Overall survival(OS) and progression-free survival(FPS) [ Time Frame: two and a half year ] [ Designated as safety issue: No ]
- European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30) [ Time Frame: every two cycles ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249690
|China, Shang Hai|
|Shanghai Changzheng Hospital||Recruiting|
|Shang Hai, Shang Hai, China, 200003|
|Contact: Hou firstname.lastname@example.org|
|Principal Investigator: Jian Hou|
|Principal Investigator:||Jian Hou, PhD||Shanghai Changzheng Hospital|