Study of Velcade and Thalidomide in Patients With Myelodysplasia
Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
研究概览
详细说明
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.
This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.
研究类型
注册
阶段
- 阶段1
联系人和位置
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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Boston、Massachusetts、美国、02115
- Dana Farber Cancer Institute
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Boston、Massachusetts、美国、02115
- Beth Israel Deaconess Medical Center
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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
描述
Inclusion Criteria:
- Myelodysplastic syndrome with a IPSS score of 0.5 or greater
- May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
- ECOG performance status of 0-2
- Life expectancy greater than 3 months
- Total bilirubin </+ 2xULN
- ALT and AST </+ 3xULN
- Calculated creatinine clearance > 30 ml/min
- Use of appropriate method of contraception during the study
- ANC > 0.5 x 10(9)
- Platelet count > 30 x 10(9)
- Consideration of treatment with 5 azacytidine is encouraged by not required
Exclusion Criteria:
- Ejection fraction < 40%
- myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Women who are pregnant or breast-feeding
- Major surgery within 4 weeks prior to enrollment
- >/= grade 2 peripheral neuropathy within 14 days prior to enrollment
- Uncontrolled intercurrent illness
- Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
- Hypersensitivity to bortezomib, boron, or mannitol
- Received an investigational drug within 14 days of enrollment
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
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次要结果测量
结果测量 |
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Assess efficacy in terms of the number of patients attaining a 50% reduction in blast percentage, or 50% reduction in number of red blood cell and/or platelet transfusions.
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Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
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Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.
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合作者和调查者
调查人员
- 首席研究员:Karen Ballen, M、Massachusetts General Hospital, Harvard University
研究记录日期
研究主要日期
学习开始
研究完成
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
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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