Studying Blood Samples From Patients With Multiple Myeloma Who Were Treated With Thalidomide or Lenalidomide
Screening of Cathepsin G Levels in Multiple Myeloma Patients Receiving Treatment With Thalidomide/Lenalidomide Within the ECOG Trials E1A00 and E4A03
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This research study is looking at blood samples from patients with multiple myeloma who were treated with thalidomide or lenalidomide.
研究概览
详细说明
OBJECTIVES:
Primary
- To analyze the mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE) in patients with multiple myeloma treated on clinical trial ECOG-E4A03 or E-E1A00.
- To determine the intensity, dynamics, and specificity of cathepsin G (CG) upregulation in response to thalidomide and lenalidomide treatment.
- To determine the specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development.
OUTLINE: Blood samples obtained before, during, and after treatment with thalidomide or lenalidomide from patients previously enrolled on clinical trial ECOG-E4A03 or E-E1A00 are analyzed to determine the total content of cathepsin G (CG) via ELISA; to determine mRNA levels of CG via RT-PCR; and for platelet aggregation studies. Blood samples are collected from healthy volunteers for platelet preparation.
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
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
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
- Diagnosed with multiple myeloma and treated with thalidomide or lenalidomide on clinical trial ECOG-E4A03 or E-E1A00
- Healthy volunteer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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 |
|---|---|
|
Proportion of patients with failed disease based on expectations for changes in cathepsin G (CG) levels
大体时间：1 month
|
1 month
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Mechanism of development of thalidomide/lenalidomide-induced venous thromboembolism (VTE)
大体时间：1 month
|
1 month
|
|
Intensity, dynamics, and specificity of CG upregulation in response to thalidomide and lenalidomide treatment
大体时间：1 month
|
1 month
|
|
Specificity and threshold levels of CG for induction of platelet aggregation in response to thalidomide and lenalidomide and the resulting risk for VTE development
大体时间：1 month
|
1 month
|
合作者和调查者
调查人员
- 学习椅：Suzanne Lentzsch, MD, PhD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
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