NCT02063113终止不适用
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- The occurrence of the events
研究概览
简要总结
The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 70 years and older
- •Patients referred for a assessment of a newly diagnosed multiple myeloma
- •Patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial.
- •Patients who provide informed written consent
排除标准
- •Patients who refuse the study
- •Patients who won't have therapy
- •Patients can't respond to geriatric assessment because of severe cognitive disorder
- •Patients with a legal guardian
结局指标
主要结局
The occurrence of the events
时间窗: 6 MONTHS
The primary outcome is either : * early interruption of treatment * dose reduction \> 20% during treatment * discontinuous treatment These outcomes will be measured every 6 months during the 2 years of follow up
次要结局
- Progression to 1 and 2 years(1 year/2year)
- Type of Vulnerability(6 MONTHS)
- Therapeutic changes(6 MONTHS)
- Toxicity during treatment(6 months)
- Complete response at 1 and 2 years(1 year/2 years)
研究者
研究点 (3)
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