Study of Combination PS-341 and Thalidomide in Multiple Myeloma
2010年7月30日 更新者:University of Arkansas
UARK 2001-37, A Phase I Exploratory Study of Combination PS-341 and Thalidomide in Refractory Multiple Myeloma
The purpose of this study is to assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma, and to find the most appropriate doses of PS-341 and thalidomide in the combination.
研究概览
详细说明
Patients will be enrolled in groups of 6-10 patients, each receiving a low dose of PS-341 (1.0 mg/m2) and different dose levels of thalidomide (50, 100, 150, and 200 mg).
The first six patients in each group will receive PS-341 alone for the first cycle, and thalidomide will be added on day 22.
If the combination is found to be safe in these first 6 patients, the remaining patients in each group will be enrolled.
Initially, these patients will receive PS-341 alone and thalidomide will be added subsequently, if deemed safe based on the first 6 patients in each thalidomide dose cohort.
研究类型
介入性
注册 (实际的)
86
阶段
- 阶段1
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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Arkansas
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Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences/MIRT
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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
描述
Inclusion Criteria:
- History of histologically documented multiple myeloma with relapsed or resistant disease, defined as previously treated with/without autologous stem cell transplantation and is either relapsing or is resistant after > 1 line of prior therapy for myeloma
- Patients can not be eligible for MTRC phase III protocols of higher priority
- Performance status of greater than or equal to 2 as per SWOG scale
- Patients must have an absolute neutrophil count > 750/mm3, and a platelet count greater than or equal to 25,000/mm3
- No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval
- Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
- Male or female adults of at least 18 years of age.
- Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations
Exclusion Criteria:
- Chemotherapy or radiotherapy received within the previous 2 weeks
- Prior Treatment of PS-341
- Significant neurotoxicity, defined as grade greater than or equal to 2 neurotoxicity per NCI Common Toxicity Criteria
- POEMS Syndrome
- Non-secretory multiple myeloma
- Active infection requiring antibiotics
- Clinically significant hepatic dysfunction in the absence of liver metastases as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis
- New York Hospital Association (NYHA) Class III or Class IV heart failure
- Myocardial infarction within the last 6 months
- Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
- Severe renal dysfunction defined as a creatinine clearance < 20 cc/min.
- Absolute neutrophil count < 750/mm3, and a platelet count < 25,000/mm3
- Pregnant or potential for pregnancy
- Breast-feeding
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
- 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)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:2个
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Arm 1 a dose of 1.0mg/m2.
Arm 2 a dose of 1.3mg/m2
In cohort 1, a dose of 50mg for cycles 2-8.
Cohort 2, 100mg for cycles 2-8.
Cohort 3, 150mg for cycles 2-8.
Cohort 4, 200mg for cycles 2-8.
A dose of 20mg for cylces 3-8.
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有源比较器:1个
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Arm 1 a dose of 1.0mg/m2.
Arm 2 a dose of 1.3mg/m2
In cohort 1, a dose of 50mg for cycles 2-8.
Cohort 2, 100mg for cycles 2-8.
Cohort 3, 150mg for cycles 2-8.
Cohort 4, 200mg for cycles 2-8.
A dose of 20mg for cylces 3-8.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Assess the toxicity of PS-341 combined with one of four doses of thalidomide in patients with refractory multiple myeloma
大体时间:until pt progresses or unexceptible toxicity
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until pt progresses or unexceptible toxicity
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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。
调查人员
- 首席研究员:Barlogie Barthel, M.D. Ph.D、University of Arkanas for Medical Sciences website
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2001年12月1日
初级完成 (实际的)
2007年11月1日
研究完成 (实际的)
2007年11月1日
研究注册日期
首次提交
2004年5月24日
首先提交符合 QC 标准的
2004年5月25日
首次发布 (估计)
2004年5月26日
研究记录更新
最后更新发布 (估计)
2010年8月2日
上次提交的符合 QC 标准的更新
2010年7月30日
最后验证
2010年7月1日
更多信息
与本研究相关的术语
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.
PS-341的临床试验
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M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.完全的
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M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.完全的