EUCTR2006-002675-41-DE进行中（未招募）不适用
A non-randomised, multi-center Phase I/II trial of safety, tolerability and efficacy of Everolimus (RAD001) in relapsed or refractory Multiple Myeloma
niversitaetsklinikum Schleswig-Holstein0 个研究点开始时间: 2006年12月15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. Multiple myeloma of Salmon-Durie stage II or III
- •2. Relapsed or refractory disease after failure of two or more treatment regimens
- •3. Age = 18
- •4. WHO performance status = 2
- •5. Measurable disease marker (M component in serum or/and urine). In oligo-secretory disease serum free light chain assay can be used as disease marker according to the International uniform response criteria for Multiple Myeloma” if the kappa/lambda-ratio is abnormal and the involved light chain is = 10 mg/dl.
- •6. Life expectancy > 6 months
- •7. Adequate bone marrow function as shown by leukocytes > 2,500/mm3 and platelets >50,000/mm3 and hemoglobin = 8g/dl
- •8. Adequate liver function as shown by:
- •serum bilirubin = 1.5 x upper limit of normal (ULN), and serum transaminases activity
- •9. Signed informed consent
- •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. Concomitant treatment with other anti-myeloma drugs in last 4 weeks, also including clarithromycin, thalidomide and its derivates. Aminobisphosphonates are allowed and recommended.
- •2. Any active infection at start of therapy which requires treatment
- •3. Any concomitant surgery except kyphoplasty
- •4. Radiotherapy (concomitantly or in the last 4 weeks) if not restricted to a single osteolytic lesion
- •5. Chronic treatment with steroids (> 5 mg predisolon equivalent) or another immunosuppressive agent
- •6. Prior treatment with any investigational drug within the preceding 4 weeks
- •7. Other malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
- •8. Plasma cell leukemia
- •9. Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure - New York Heart Association Class III or IV, ventricular arrhythmias active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration)
- •10. A known history of HIV seropositivity
- •11. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
- •12. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
- •13. Women who are pregnant or breast feeding, or women able to conceive and unwilling to practice an effective method of birth control. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of RAD001). Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and and are therefore to be handled with care for this study
- •14. Severe active pulmonary disease or history of drug/radiation induced pneumonitis
- •15. Patients with grade 3 hypercholesterolemia/hypertriglyceridemia or = grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid lowering treatment if given)
- •16. Patients who received prior therapy with RAD001 or other mTOR inhibitors
研究者
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