EUCTR2013-005157-75-DK进行中（未招募）1 期
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients
HOVON Foundation0 个研究点目标入组 61 人开始时间: 2016年6月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 61
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
- •- Patients with diagnosis of symptomatic pPCL (see appendix A)
- •- Measurable disease as defined by the presence of M-protein in serum or urine (serum M-protein > 10 g/l or urine M-protein > 200 mg/24 hours or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l) or proven plasmacytoma by biopsy)
- •- Age =18 years
- •- WHO-performance status 0-3 (but WHO=3 is allowed only when caused by pPCL and not by co-morbid conditions)
- •- Written informed consent
- •- Patient capable of giving informed consent (patient is legally, physically and mentally capable of giving consent)
- •- Negative pregnancy test at entry (if applicable)
- •- All men and women of childbearing potential should use adequate highly effective contraception during the study. Men should be offered sperm banking before starting treatment (if applicable).
- •- Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program (PPP) throughout study treatment
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •- Any current CNS involvement with disease refractory to intrathecal chemotherapy.
- •- Female patients who are pregnant or breast feeding.
- •- HIV positive patients
- •- Active malignancy other than pPCL requiring treatment, or a malignancy that has been treated with chemotherapy currently affecting bone marrow capacity
- •- Patients with active, uncontrolled infections
- •- Severe neurological or psychiatric disease
- •- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E) - Myocardial infarction within 6 months, unstable angina, and cardiac arrhythmias which are not controlled by conventional treatment (including medications and cardiac devices)
- •- Severe pulmonary dysfunction
- •- Significant hepatic dysfunction (serum bilirubin or transaminases = 3.0 times normal level), unless related to pPCL
- •- Patients with GFR < 15 ml/min
- •- Known history of allergy to Capsidol (a cyclodextrin derivative used to solubilize carfilzomib)
- •- Hypersensitivity to the active substances or to any of the excipients of the drug products
- •- Previous chemotherapy or radiotherapy except local radiotherapy in case of local myeloma progression or corticosteroids maximum 7 days for symptom control or stabilization(this includes dexamethasone 40 mg daily) or inthrathecal chemotherapy in case of CNS involvement
- •- Systemic AL amyloidosis
- •- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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