EUCTR2007-006037-13-IT进行中（未招募）不适用
An open-label, phase II study of cyclophosphamide, lenalidomide and dexamethasone (CLD) for previously treated patients with AL amyloidosis - ND
OSPEDALE POLICLINICO S. MATTEO0 个研究点开始时间: 2007年12月10日最近更新:
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
- •Diagnosis of AL amyloidosis;evidence of a monoclonal light chain at serum and/or urine immunofixation electrophoresis;elevated circulating free light chain (of the type identified by immunofixation) above the upper limit of the normal range.Age >/=18 years.Must have been previously treated (failed at least 1 previous treatment for AL amyloidosis) and in the opinion of the investigator requires further treatment.Symptomatic organ (heart, kidney, liver, peripheral nervous system or soft tissue) involvement.Bone marrow plasma cell <30% in bone marrow aspirate. Echocardiographic ejection fraction >/=40%. Troponin I <0.1 ng/mL.Hemoglobin >/=10 g/dL.Absolute neutrophil count >1500/mcL.Platelet count >/=140000/mcL.Total bilirubin <2.5 mg/dL.Alkaline phosphatase <4 x upper reference limit (u.r.l.). ALT 30 mL/min x 1.73 m2 (according to MDRD). Female subjects of childbearing potential (FCBP) must have two negative pregnancy tests prior to starting study drug.Male: 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.
- •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
- •Prior treatment with CTD or lenalidomide.Requirement for other concomitant chemotherapy, immunotherapy or radiotherapy, or any investigational ancillary therapy.Presence of other active malignancies, with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate specific antigen is within normal limits.Clinically overt multiple myeloma.Uncontrolled infection. New York Heart Association (NYHA) class 4 heart failure.Enzyme documented myocardial infarction within 6 months before enrollment.Grade 2 or 3 atrioventricular block (Mobitz type I is permitted).Repetitive ventricular arrhythmias at 24 h Holter electrocardiogram in spite of treatment with amiodarone.Supine systolic blood pressure <90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of >20 mmHg in spite of being treated for orthostatic hypotension.Patient has a prior history of thrombosis or venous thromboembolism or pulmonary embolism.Patient has a prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency.Patient has a clear indication to receive clopidogrel, ticlopidine or warfarin.Factor X level <20%.Stool guaiac tests result positive (1 of 3); further diagnostic workup for a bleeding source should be performed and the subject reevaluated for study entry.Poorly controlled diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months).Previous or ongoing psychiatric illness (with the exclusion of reactive depression). Pregnant or nursing women.
研究者
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