NCT00872352Unknown3 期
Phase 3 Study to Evaluate Bortezomib Induced Peripheral Neuropathy of Multiple Myeloma (MM) Patients.
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables.
研究概览
简要总结
In the present study we are planning to study electrophysiological changes related to the dose and time of bortezomib administration in newly diagnosed patients with MM, during the first months of treatment and 6 months after ending. In addition a possible correlation between the incidence of BIPN and the subtype of myeloma and other risk factors will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple Myeloma stage II, III (Durie and Salmon staging) prior to Bortezomib Therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Be willing and able to comply with the protocol treatment for the duration of the study
- •Patient's written informed consent
排除标准
- •Multiple Myeloma on progression
- •Incidence of Relapsed or Refractory Myeloma
- •Patients with the existing neuropathy at the time of the diagnosis
结局指标
主要结局
A dose-related neurotoxic effect of bortezomib will be determined through regression analysis with the change in TNSr as the dependent variable Bortezomib doses will use as independent variables.
时间窗: 3 months
次要结局
- To accommodate the dose of bortezomib with the progression of Peripheral Neuropathy(4 months)
研究者
研究点 (2)
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