Clinical Evaluation of the Serum Free Light Chain Analysis
Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment
Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective.
A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.
Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.
Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
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Odense C、丹麦、5000
- 招聘中
- Department of Haematology, research unit
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接触：
- Charlotte T Hansen, Fellow
- 电话号码：0045 24428085
- 邮箱：charlotte.toftmann.hansen@ouh.regionsyddanmark.dk
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首席研究员：
- Charlotte T Hansen, Fellow
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- diagnosis of multiple myeloma
- abnormal serum free light chains
- medical needs of anti-myeloma therapy
- receiving standard anti-myeloma therapy
Exclusion Criteria:
- dialysis
- normal serum free light chains
- dementia
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein
大体时间：1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,
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1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,
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合作者和调查者
调查人员
- 首席研究员：Charlotte T Hansen, Fellow、Department of Haematology, research unit
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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