Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
研究概览
简要总结
This observational study will observe the degree of the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions). Both tools are validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma by analyzing factors that affect the quality of life.
详细描述
Many clinical studies for the treatment of multiple myeloma have been conducted in Korea, but none of them have evaluated the improvement in the quality of life in patients with multiple myeloma. Most study variables used to evaluate the quality of life of patients with multiple myeloma are subjective and limited. This study will observe the degree of change in the quality of life in patients with multiple myeloma before and after bortezomib administration by using EORTC-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) and EQ-5D (EuroQol-5 Dimensions), validated research instruments used to measure the quality of life in cancer patients and consequently will provide fundamental data regarding the quality of life in patients with multiple myeloma.. Observational Study - No investigational drug administered
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma
- •Patients who can understand and fill out quality of life questionnaires, and who agree to provide information will be included
排除标准
- •Patients who are hypersensitive to the bortezomib or any component of bortezomib or with a history of the hypersensitivity
- •Patients with severe hepatic impairment
- •Pregnant women
研究组 & 干预措施
001
干预措施: bortezomib (Drug)
结局指标
主要结局
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
时间窗: Before the first, after the fourth and at the last IV cycle of bortezomib
次要结局
- Relationship between the primary outcome and the complete remission (CR) rate(Before the first, after the fourth and at the last IV cycle of bortezomib)
- Adverse events(Every 3 week cycle)
- Relationship between the primary outcome and the overall response rate(Before the first, after the fourth and at the last IV cycle of bortezomib)
- Relationship between the primary outcome and the time to response(Before the first, after the fourth and at the last IV cycle of bortezomib)