NCT01002703Unknown1 期
Treatment With Lenalidomide, Bendamustine and Prednisone (RBP) in Patients With Relapsed or Refractory Multiple Myeloma After Autologous Stem Cell Transplantation or Conventional Chemotherapy OSHO #077
University of Leipzig1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III
研究概览
简要总结
Define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign an informed consent form.
- •Age 18 years at the time of signing the informed consent form.
- •Life expectancy of at least 3 months
- •Able to adhere to the study visit schedule and other protocol requirements
- •Relapsed or refractory MM (only first or second relapse) in stage II or III after autologous SCT or conventional chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria) with detectable myeloma protein in blood or urine
- •All previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy.
- •ECOG performance status of £ 2 at study entry (see Appendix 01).
- •Laboratory test results within ranges
- •Females of childbearing potential must agree to contraception or abstinence
- •Disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or breast feeding females.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone.
- •Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, New York Heart Association Class III or IV heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3).
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to thalidomide or purine analogues
- •The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •Any prior use of lenalidomide or bendamustine in the last six months
- •Concurrent use of other anti-cancer agents or treatments other stated in this treatment plan.
- •Known positive for HIV or infectious hepatitis, type A, B or C.
研究组 & 干预措施
RBP
Experimental
Lenalidomide and Bendamustine and Prednisone
干预措施: Lenalidomide, Bendamustine, Prednisone (Drug)
结局指标
主要结局
To determine the maximum tolerable dose (MTD) of lenalidomide in combination with bendamustine and prednisone (RBP) in refractory and relapsed MM stage I/III
时间窗: 2 month
次要结局
- To determine the safety of lenalidomide, bendamustine and prednisone at MTD(2 years)
研究者
研究点 (1)
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