EUCTR2007-004007-34-DK进行中（未招募）1 期
Randomized phase III trial in elderly patients with previously untreated symptomatic Multiple Myeloma comparing MP-Thalidomide (MP-Thal) followed by thalidomide maintenance versus MP-Lenalidomide (MP-Len) followed by maintenance with lenalidomide - HOVON 87 MM
HOVON Foundation0 个研究点目标入组 668 人开始时间: 2009年3月17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
- 668
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
- •- Previously untreated patients with a confirmed diagnosis of symptomatic multiple myeloma according to IMWG criteria
- •- Age > 65 years or patients = 65 not eligible for high dose chemotherapy and peripheral stem cell transplantation
- •- WHO performance status 0-3 for patients <75 years and WHO performance status 0-2 for patients =75 years
- •- Measurable disease as defined by the presence of M-protein in serum or urine
- •- 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
- •- Non-secretory MM
- •- Known hypersensitivity to thalidomide
- •- Systemic AL amyloidosis
- •- Polyneuropathy, grade 2 or higher
- •- Severe cardiac dysfunction (NYHA classification II-IV)
- •- Severe pulmonary dysfunction
- •- Significant hepatic dysfunction (total bilirubin =30 umol/l or transaminases =3 times normal level), unless related to myeloma
- •- Creatinine clearance < 30 ml/min
- •- Patients with active, uncontrolled infections
- •- Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors. Radiotherapy or a short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or equivalent) are allowed.
- •- Patients known to be HIV-positive
- •- History of active malignancy during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma
- •- Not able and/or not willing to use adequate contraception
研究者
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