Quality of Life in Multiple Myeloma Patients Treated With Bortezomib
2014年12月22日 更新者：Janssen Korea, Ltd., Korea
Evaluation of Improvement of Quality of Life in Multiple Myeloma Patients Treated With Velcade (Bortezomib) IV: Prospective, Multicenter, Observational Study
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.
研究概览
详细说明
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
研究类型
观察性的
注册 (实际的)
140
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Among patients who are newly prescribed bortezomib injection as a secondary agent for the treatment of multiple myeloma, those of whom can understand and fill out questionnaire, and agree to provide information will be included.
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
001
|
静脉注射 1.3 mg/m2，每周两次，持续 21 天
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The change in the quality of life as measured by EORTC QLQ-C30 and EQ-5D before and after the administration of bortezomib
大体时间：Before the first, after the fourth and at the last IV cycle of bortezomib
|
Before the first, after the fourth and at the last IV cycle of bortezomib
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Relationship between the primary outcome and the complete remission (CR) rate
大体时间：Before the first, after the fourth and at the last IV cycle of bortezomib
|
Before the first, after the fourth and at the last IV cycle of bortezomib
|
|
Relationship between the primary outcome and the overall response rate
大体时间：Before the first, after the fourth and at the last IV cycle of bortezomib
|
Before the first, after the fourth and at the last IV cycle of bortezomib
|
|
Relationship between the primary outcome and the time to response
大体时间：Before the first, after the fourth and at the last IV cycle of bortezomib
|
Before the first, after the fourth and at the last IV cycle of bortezomib
|
|
Adverse events
大体时间：Every 3 week cycle
|
Every 3 week cycle
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年3月1日
初级完成 (实际的)
2008年7月1日
研究完成 (实际的)
2008年7月1日
研究注册日期
首次提交
2009年11月25日
首先提交符合 QC 标准的
2009年11月25日
首次发布 (估计)
2009年11月30日
研究记录更新
最后更新发布 (估计)
2014年12月23日
上次提交的符合 QC 标准的更新
2014年12月22日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.