JPRN-jRCT2091220135已完成2 期
Single arm open-label trial to investigate the efficacy and safety of FPF300 as a remmision induction treatment for POEMS (Crow-Fukase) syndrome - J-POST13
Chiba University hospital, department of neurology and clinical research center0 个研究点目标入组 10 人开始时间: 2013年8月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •(1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria)
- •(2) Patients who wish to undergo high-dose chemotherapy with autologus stem cell transplantation
- •(3) Over 20 years old and less than 66 years old
- •(4) Patients wihtout severe liver or renal dysfunction on the screening test
- •(5) Patients who are capable of hospital admission at the time of startting clinical trial
- •(6) Patients who are capable of ambulatory hospital visits evry 4 weeks.
- •(7) Patients who have an clinicaly probrematic ECG
- •(8) Patients with written informed consent.
- •(9) Patients with informed consent to thalidomide education and risk management system
排除标准
- •(1) Patients who have recieved thalidomide, lenalidomide, melpharan, or bortezomib within 4 weeks prior to the informed consent.
- •(2)Patients who have recieved bevacizumab within 12 weeks prior to the informed consent.
- •(3) Patients who have recieved systemic steroid administration (over than 10mg/day of predonisone)
- •(4) Pateints who could worsen acutely during the clinical trial period
- •(5) Females who are pregnant or desire childbearing. Males who desire fertility
- •(6) Patients who have severe complications (cardiac failure, renal failure, liver failure, bleedin ulcer, ileus, diabetes with poorly controlled hyperglycemia)
- •(7) Patients who have other malignancy (including myeloma or primary macroglobulinemia)
- •(8) Patients with past medical history of allergy to thalidomide or dexamethasone
- •(9) Patients with serious mental disorder
- •(10) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent.
- •(11) Patients who have received drugs or therapy prohibited in the clinical trial within 4 weeks
- •(12) Patients who are not appropriate to participate to the trial
研究者
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