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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria
研究概览
简要总结
The primary purpose of this study is to evaluate the efficacy of PAD-regimen and TAD-regimen in newly diagnosed multiple myeloma(MM).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
PAD
干预措施: Bortezomib,Pirarubicin,Dexamethasone (Drug)
TAD
干预措施: Thalidomide,Pirarubicin,Dexamethasone (Drug)
结局指标
主要结局
The overall response rate of PAD and TAD in patients with MM assessed by International Myeloma Working Group(IMWG) criteria
时间窗: every treatment cycle
次要结局
- 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)
- The concentrations of bone metabolites(every two cycles)