Retrospective Survey of Re-treatment With Bortezomib
2012年6月11日 更新者:Janssen Pharmaceutica N.V., Belgium
Retrospective Evaluation of Re-Treatment With Bortezomib in Subjects With First Relapse After Bortezomib First-Line Therapy
The purpose of this retrospective study is to collect information about patients who received bortezomib as their first chemotherapy and who responded well to it, but who relapsed afterwards and were treated again with bortezomib a second time after a treatment-free period of at least 6 months.
During this non-interventional study (this means that no drug is being tested in this study) the safety and effectiveness (whether it works or not) of bortezomib re-treatment will be evaluated in patients with multiple myeloma.
Only data already mentioned in your clinical file will be collected.
About 100 adult patients will take part in the study
研究概览
详细说明
This is an international, multicenter, non-interventional, retrospective study to evaluate the efficacy and safety of bortezomib in 100 adult patients diagnosed with multiple myeloma (MM) who responded to bortezomib as first-line treatment, experienced partial response or better, presented with relapsed disease, and were re-treated (second-line) with bortezomib (for at least 3 cycles) after a treatment-free interruption of at least 6 months.
As this is a non-interventional study, no changes to the current treatment that the patient receives will be required, and no additional treatment will be provided by the company.
The decision of the patients to take part in this study will not have any impact on the care they receive.
All the appropriate treatment-related decisions will have been made by the treating physician(s), and only data available from clinical practice will be collected.
Retrospective data will be collected at a single time point for each patient (the data collection visit).
Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria.
After receiving the signed informed consent form (ICF) from the patient (if required by local regulations), the investigator will start documenting the retrospective data for each patient using electronic data capture (eDC).
After confirmation of the patient's eligibility, the patient's last visit, patient characteristics, predefined risk factors (if available), MM-related data, and first- and second-line bortezomib-related data will be documented in the Case Report Form (CRF).
The patient's status after re-treatment with bortezomib, medical resource utilization data, as well as (serious) adverse drug reactions ([S]ADRs) will be collected.
No blood, urine, or other biological samples will be taken, and no additional investigations will be performed.
the current therapy of the patient will be maintained with no changes
研究类型
观察性的
注册 (实际的)
35
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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Alexandroupoli、希腊
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Athens、希腊
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Athens Attica、希腊
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Patra、希腊
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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
Clinic; Hospital
描述
Inclusion Criteria:
- Has a current diagnosis/was diagnosed with MM or secretory MM
- Was previously treated with bortezomib-containing chemotherapy
- Responded to bortezomib as first-line treatment
- Has been re-treated with bortezomib (at least 3 cycles) due to relapse of the disease (following the first bortezomib treatment), after a treatment-free interruption of at least 6 months
- Completed bortezomib re-treatment at least 2 months ago Exclusion Criteria:
- Was a pregnant or breastfeeding woman while receiving either first-line or second-line treatment with Velcade
Has received bortezomib-containing chemotherapy for the first time following a first relapse or later
- Has participated in a clinical trial in which bortezomib was used as second-line treatment following a relapse after response to Velcade as first-line chemotherapy, and the study data are not publicly available at the time of inclusion in the current study
- Has received bortezomib as first-line therapy and was re-treated with bortezomib after first relapse in the VISTA clinical trial
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 |
|---|---|
|
bortezomib retreatment
bortezomib retreatment due to relapse Patients who received bortezomib-containing chemotherapy as first-line treatment for MM experienced partial response or better and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
|
Patients who received bortezomib-containing chemotherapy as first-line treatment for MM, experienced partial response or better, and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
|
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 |
|---|---|---|
|
overall response after retreatment
大体时间:Day 1
|
overall response after retreatment will be assessed from initial diagnosis to the time of data collection
|
Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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number of medical care encounters
大体时间:Day 1
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number of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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duration of medical care encounters
大体时间:Day 1
|
duration of medical care encounters are collected retrospectively from initial diagnosis to the time of data collection
|
Day 1
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duration of hospitalization
大体时间:Day 1
|
duration of hospitalizations are collected retrospectively from initial diagnosis to the time of data collection
|
Day 1
|
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number and character of diagnostic and therapeutic tests and procedures
大体时间:Day 1
|
number and character of diagnostic and therapeutic tests and procedures are collected retrospectively from initial diagnosis to the time of data collection
|
Day 1
|
|
outpatient medical encounters and treatments
大体时间:Day 1
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outpatient medical encounters and treatments are collected retrospectively from initial diagnosis to the time of data collection
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Day 1
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safety and tolerability
大体时间:Day 1
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safety and tolerability will be evaluated based on the collection of serious and non serious adverse drug reactions from initial diagnosis to the time of data collection
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Day 1
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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。
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
2011年3月1日
研究完成 (实际的)
2011年10月1日
研究注册日期
首次提交
2011年6月16日
首先提交符合 QC 标准的
2012年2月1日
首次发布 (估计)
2012年2月2日
研究记录更新
最后更新发布 (估计)
2012年6月12日
上次提交的符合 QC 标准的更新
2012年6月11日
最后验证
2012年6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.