Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT01249690|
Recruitment Status : Unknown
Verified May 2010 by Second Military Medical University.
Recruitment status was: Recruiting
First Posted : November 30, 2010
Last Update Posted : November 30, 2010
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bortezomib,Pirarubicin,Dexamethasone Drug: Thalidomide,Pirarubicin,Dexamethasone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||June 2014|
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.
- 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 ]
- The concentrations of bone metabolites [ Time Frame: every two cycles ]
- chromosome examination by cytogenetic and interphase Fluorescence in situ hybridization(FISH) method [ Time Frame: at baseline ]
- Overall survival(OS) and progression-free survival(FPS) [ Time Frame: two and a half year ]
- European Organisation for Research and Treatment of Cancer Quality Of life-Questionnaires-C30 (EORTC QLQ-C30) [ Time Frame: every two cycles ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249690
|China, Shang Hai|
|Shanghai Changzheng Hospital||Recruiting|
|Shang Hai, Shang Hai, China, 200003|
|Contact: Hou email@example.com|
|Principal Investigator: Jian Hou|
|Principal Investigator:||Jian Hou, PhD||Shanghai Changzheng Hospital|