EUCTR2009-014922-40-NL进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
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 a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria (see appendix I);
- •·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) (see appendix II);
- •·Negative urine pregnancy test at inclusion if applicable;
- •·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 145
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Known intolerance of Thalidomide;·Systemic AL amyloidosis;·Non-secretory MM;·Waldenstrom’s macroglobulinemia or IgM MM;·Previous chemotherapy or radiotherapy except 2 cycles of Melphalan/Prednisone or local radiotherapy in case of local myeloma progression;·Severe cardiac dysfunction (NYHA classification II-IV, see appendix);·Significant hepatic dysfunction (serum bilirubin ³ 30 mmol/L or transaminases ³ 2.5 times normal level), unless related to myeloma;·Creatinine clearance (measured or calculated) <30cc/min·Alkaline Phosphatase >3x ULN·ANC < 1,0 x109/L, platelets < 75 x109/L, Hb < 4.9 mmol/L·Non-secretory MM defined as SPEP < 5 g/L and UPEP < 200 mg/24 hr·Intolerance to thromboprophylaxis;·Patients known to be HIV-positive;·Patients with active, uncontrolled infections;·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;·Patients (all males and all pre-menopausal women) who are not willing or capable to use adequate contraception during the therapy;·Lactating women;·WHO Performance status > 3.
研究者
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