EUCTR2013-005157-75-GB进行中（未招募）1 期
Carfilzomib and lenalidomide-based treatment for younger and elderly newly diagnosed primary plasma cell leukemia patients - EMN12/HO129
HOVO0 个研究点目标入组 16 人开始时间: 2020年8月3日最近更新:
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
- 16
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
- •? 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 >100 mg/l) or proven plasmacytoma by biopsy)
- •? Age =18 years
- •? WHO-performance status 0-3
- •? Written informed consent
- •? Patient capable of giving informed consent
- •? All men and women of childbearing potential should use adequate contraception during the study.
- •? Negative pregnancy test at entry (if applicable)
- •? Patient is willing and able to adhere to the requirements of the lenalidomide Pregnancy Prevention Program.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •? Severe pulmonary dysfunction
- •? Significant hepatic dysfunction, unless related to pPCL
- •? Patients with GFR <15 ml/min
- •? Known history of allergy to Capsidol
- •? Hypersensitivity to the active substances (carfilzomib, lenalidomide and dexamethasone)or to any of the excipients of these drug products
- •? Previous chemotherapy or radiotherapy, except local radiotherapy in case of local myeloma progression or corticosteroids maximum 7 days for symptom control or stabilisation (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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