EUCTR2007-002533-37-BE进行中（未招募）1 期
Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma - HOVON 86 MM
HOVON Foundation0 个研究点目标入组 84 人开始时间: 2009年9月7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
- 84
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
- •- Multiple Myeloma Salmon/Durie stage II/III A+B
- •- Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment
- •- Age 60 – 85 years inclusive
- •- Not a candidate for high-dose therapy
- •-Measurable disease, i.e., serum M-component (>10 g/l), or urinary light-chain excretion (>200mg/24h),or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l or proven plasmacytoma by biopsy
- •- Able and/or willing to use adequate contraceptives (especially male patients)
- •- Written 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
- •-Prior therapy with Bortezomib or Lenalidomide
- •-History of allergic reaction attributable to compounds containing boron or mannitol.
- •-Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3.
- •-AL amyloidosis
- •- Uncontrolled or severe cardiovascular disease:
- •New York Heart Association (NYHA) Class III or IV heart failure
- •Myocardial infarction within the last 6 months of study entry
- •Reduced left ventricular function with an ejection fraction < 50% as measured by
- •MUGA scan or echocardiogram (another method for measuring cardiac function is
- •acceptable)
- •Unstable angina
- •Unstable cardiac arrhythmias
- •Clinically significant pericardial disease
- •- Impaired hepatic or renal function as defined by:
- •ALT and/or AST > 3 x normal value
- •Bilirubin > 3 x normal value
- •Serum creatinin > 3 x normal value (after adequate hydration)
- •- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
- •diabetes, infection, hypertension, etc.)
- •- Known HIV positivity
- •- History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
研究者
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