Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma

Sponsor

Second Military Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01249690

Collaborator

Zhejiang University (Other), Peking University People's Hospital (Other), Air Force Military Medical University, China (Other), Xiangya Hospital of Central South University (Other), Institute of Hematology & Blood Diseases Hospital (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)

100

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Bortezomib,Pirarubicin,Dexamethasone Drug: Thalidomide,Pirarubicin,Dexamethasone	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PAD	Drug: Bortezomib,Pirarubicin,Dexamethasone 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.
Experimental: TAD	Drug: Thalidomide,Pirarubicin,Dexamethasone 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.

Arm

Intervention/Treatment

Experimental: PAD

Drug: Bortezomib,Pirarubicin,Dexamethasone

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.

Experimental: TAD

Drug: Thalidomide,Pirarubicin,Dexamethasone

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.