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Efficacy Study of PAD and TAD in Newly Diagnosed Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Bortezomib,Thalidomide,bone metabolites
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bortezomib,Pirarubicin,Dexamethasone
Type: Drug
Name: Thalidomide,Pirarubicin,Dexamethasone
Type: Drug
Overall Status
Recruiting
Summary
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
- 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.
Location
Shanghai Changzheng Hospital
Shang Hai, Shang Hai, China
Status: Recruiting
Contact: Hou - houjian_czyy@sina.cn
Start Date
June 2010
Completion Date
June 2014
Sponsors
Second Military Medical University
Source
Second Military Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page