EUCTR2007-003784-42-DE进行中（未招募）不适用
Dose-finding study of lenalidomide as maintenance therapy in multiple myeloma after allogeneic stem cell transplantation - Revlimid as Maintenance in MM
niversity Medical Center Hamburg-Eppendorf0 个研究点开始时间: 2008年9月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Understand and voluntarily sign an informed consent form
- •2. Age >18 years at the time of signing the informed consent form
- •3. Able to adhere to the study visit schedule and other protocol requirements
- •4. Multiple myeloma patients who received allogeneic stem cell transplantation (100
- •to 180 days ago)
- •5. No active acute GvHD (grade II – IV)
- •6. No active infectious complications
- •7. ECOG performance status of < 2 at study entry
- •8. Laboratory test results within these ranges:
- •Absolute WBC count >3.0 x 10^9/l
- •Platelet count > 80 x 10^9/l
- •Serum creatinine < 1.5 mg/dl
- •Total bilirubin < 1.5 mg/dl
- •AST (SGOT) and ALT (SGPT) < 3 x ULN
- •9. Females of childbearing potential (FCBP) must agree to use two reliable forms of
- •contraception simultaneously or to practice complete abstinence from
- •heterosexual intercourse during the following time periods related to this study:
- •1) for at least 28 days before starting study drug; 2) while participating in the
- •study; and 3) for at least 28 days after discontinuation from the study. The two
- •methods of reliable contraception must include one highly effective method (i.e.
- •intrauterine device (IUD), hormonal [birth control pills, injections, or implants],
- •tubal ligation, partner’s vasectomy) and one additional effective (barrier) method
- •(i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified
- •provider of contraceptive methods if needed
- •10. Male subjects must agree to use a latex condom during sexual contact with
- •females of childbearing potential while participating in the study and for at least
- •28 days following discontinuation from the study even if he has undergone a
- •successful vasectomy
- •11. Disease free of prior malignancies for > 5 years with exception of currently
- •treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ” of
- •the cervix or breast
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
- •would prevent the subject from signing the informed consent form
- •2. Pregnant or breast feeding females. (Lactating females must agree not to breast
- •feed while taking lenalidomide)
- •3. Use of any other experimental drug or therapy within 28 days of baseline
- •4. Known hypersensitivity to thalidomide
- •5. Concurrent use of other anti-cancer agents or treatments
- •6. Known positive for HIV or infectious hepatitis, type A, B, or C
研究者
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