Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma (METRO)
2015年7月27日 更新者：Centre Hospitalier Universitaire de Saint Etienne
Study of Thrombin Generation During the 3 First Cycles of Chemotherapy in Patients With Newly Diagnosed Multiple Myeloma: a Multicentric Study
Patients with Multiple Myeloma (MM) are at increased risk of venous thromboembolic event, especially in newly diagnosed patients and during induction treatment with thalidomide in combination with dexamethasone. This association was mainly heightened during the 3 first months of chemotherapy.
Several coagulation abnormalities have been described. Laboratory tests measuring the overall thrombophilic tendency might be useful to assess thrombosis risk.
The aim of this study is to compare thrombin generation by calibrated automated thrombogram during the 3 first cycles of chemotherapy in patients with newly diagnosed MM.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
71
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
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Clermont-ferrand、法国、63000
- CHU de Clermont Ferrand
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Nancy、法国、54000
- Chu de Nancy
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Saint Etienne、法国、42055
- Service de Médecine Interne - CHU de Saint Etienne
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Saint Etienne、法国、42055
- Service de rhumatologie - CHU de Saint Etienne
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Saint Priest en Jarez、法国、42270
- Service d'hématologie - ICL
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-
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
Patients with newly diagnosed Multiple Myeloma required chemotherapy
描述
Inclusion Criteria:
- Inscription to medical assurance
- Patients who gave their written consent
- Patients with newly diagnosed Multiple Myeloma required chemotherapy
Exclusion Criteria:
- Patients with renal failure who need to undergo hemodialysis
- Patients with indication for curative anticoagulant therapy
- Patient with 3 month follow-up not possible
- Patient with life expectancy < 6 month
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 |
|---|
|
Patients with Multiple Myeloma
Patients with newly diagnosed Multiple Myeloma required chemotherapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change from baseline in Thrombin generation measure
大体时间：day 21
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change from baseline in Thrombin generation measure
|
day 21
|
|
change from baseline in Thrombin generation measure
大体时间：day 42
|
change from baseline in Thrombin generation measure
|
day 42
|
|
change from baseline in Thrombin generation measure
大体时间：day 63
|
change from baseline in Thrombin generation measure
|
day 63
|
|
change from baseline in Thrombin generation measure
大体时间：day 0
|
change from baseline in Thrombin generation measure
|
day 0
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
image-confirmed venous thromboembolic events
大体时间：day 63
|
Estimate the incidence of venous thromboembolic events until day 63
|
day 63
|
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change from baseline in TFPI resistance measure
大体时间：day 21
|
change from baseline in TFPI resistance measure
|
day 21
|
|
change from baseline in acquired protein S deficiency measure
大体时间：day 21
|
change from baseline in acquired protein S deficiency measure
|
day 21
|
|
change from baseline in TFPI resistance measure
大体时间：day 42
|
change from baseline in TFPI resistance measure
|
day 42
|
|
change from baseline in TFPI resistance measure
大体时间：day 63
|
change from baseline in TFPI resistance measure
|
day 63
|
|
change from baseline in acquired protein S deficiency measure
大体时间：day 42
|
change from baseline in acquired protein S deficiency measure
|
day 42
|
|
change from baseline in acquired protein S deficiency measure
大体时间：day 63
|
change from baseline in acquired protein S deficiency measure
|
day 63
|
|
change from baseline in TFPI resistance measure
大体时间：day 0
|
change from baseline in TFPI resistance measure
|
day 0
|
|
change from baseline in acquired protein S deficiency measure
大体时间：day 0
|
change from baseline in acquired protein S deficiency measure
|
day 0
|
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。
调查人员
- 首席研究员：Bernard TARDY, MD-PhD、CHU de Saint-Etienne - CIC-EC (CIE3)
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
2012年1月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2015年6月1日
研究注册日期
首次提交
2011年12月15日
首先提交符合 QC 标准的
2012年1月9日
首次发布 (估计)
2012年1月12日
研究记录更新
最后更新发布 (估计)
2015年7月28日
上次提交的符合 QC 标准的更新
2015年7月27日
最后验证
2015年7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.