NL-OMON46962已完成2 期
Carfilzomib in combination with Thalidomide and Dexamethasone for remission induction and consolidation of Multiple Myeloma at first presentation - The Carthadex trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 145
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
- 18 至 99（—）
入选标准
- •- Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;
- •- Age 18-65 years inclusive;
- •- WHO performance status 0-3 (WHO<=3 is allowed only when caused by MM and
- •not by co-morbid conditions);
- •- Negative urine pregnancy test at inclusion if applicable;
- •- Written informed consent.
排除标准
- •- Known intolerance of Thalidomide;
- •- Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone
- •or local radiotherapy in case of local myeloma progression;
- •- Severe cardiac dysfunction;
- •- Creatinine clearance <30cc/min;
- •- ANC < 1,0 x109/L, platelets < 75 x109/L, Hb < 4.9 mmol/L;
- •- Patients with neuropathy, CTC grade 3 or higher or grade 2 painful peripheral neuropathy;
- •- Patients with a history of active malignancy during the past 5 years with the
- •exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
研究者
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