Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) in Patients With Multiple Myeloma
Thalidomide, Cyclophosphamide, Oral Idarubicin and Dexamethasone (T-CID) as Induction Therapy and a Randomized Trial of Thalidomide vs Thalidomide Plus Oral Idarubicin as Maintenance Therapy in Patients With Multiple Myeloma
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
Induction therapy: To evaluate the efficacy and toxicity of thalidomide, cyclophosphamide, oral idarubicin and dexamethasone (T-CID) in patients with relapsed or refractory multiple myeloma.
Maintenance therapy: Randomized trial to compare efficacy and toxicity of thalidomide and thalidomide plus oral idarubicin as maintenance therapy in patients with at least stable disease after T-CID.
研究概览
详细说明
Background: In some studies, thalidomide in combination with chemotherapy has been shown to be effective in patients with relapsed or refractory multiple myeloma (MM). In this study, the researchers have chosen a regimen which can be administered on an outpatient basis.
After 3-8 cycles of T-CID patients with at least stable disease will be randomized to receive thalidomide or thalidomide plus oral idarubicin as maintenance therapy for at least one year or until progression.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Bonn、德国、53105
- 招聘中
- Medical Clinic & Policlinic III, University of Bonn
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接触：
- Ingo Schmidt-Wolf, MD
- 电话号码：+49-228-287-15507
- 邮箱：picasso@uni-bonn.de
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首席研究员：
- Ingo Schmidt-Wolf, MD
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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:
- Patients with multiple myeloma according to British Columbia Cancer Agency Criteria
- Stage IIA/B or IIIA/B according to Durie/Salmon
- Symptomatic or progressive disease
Status of disease:
- refractory disease after standard induction therapy
- OR relapse after standard induction therapy
- OR relapse after high-dose chemotherapy/stem cell transplantation
- OR patients with plasma cell leukemia
- Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration
- Written informed consent
Exclusion Criteria:
- Age < 18 years
- Life expectancy of less than 3 months
- Intolerance to the study drugs
- No change or progressive disease after prior therapy with idarubicin or cyclophosphamide
- Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4
- Acute infection
- Actually decompensated diabetes mellitus
- Total bilirubin > 3.0 mg/dl
- Pregnant or breast-feeding women
- Polyneuropathy grade 2 or higher
- Ulcus ventriculi or duodeni
- Narrow or open angle glaucoma
- Not-compensated psychiatric diseases
- Prior erythroblastopenia
- Prior therapy with investigational drugs within the last 4 weeks
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：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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Induction therapy: response rate, overall survival, death rate
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Maintenance therapy: progression-free survival, overall survival, number of patients discontinuing therapy due to toxicity
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次要结果测量
结果测量 |
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Induction therapy: number of patients discontinuing therapy due to toxicity, number of patients experiencing toxicity grade 3 or 4
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Maintenance therapy: dose intensity, number of patients experiencing toxicity grade 3 or 4
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合作者和调查者
调查人员
- 首席研究员：Ingo Schmidt-Wolf, MD、University of Bonn
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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 (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.