NCT00337506终止2 期
A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Complete remission after 4 cycles:
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of MM according to the SWOG criteria (annex 1)
- •previously untreated (localized radiotherapy is allowed)
- •symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
- •with measurable levels of paraprotein in the serum (> 1g/dl) or in the urine (> 0.2g/24h)
- •age < 75 years
- •able to understand and to given an informed consent
- •male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
- •no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.
排除标准
- •life expectancy < 2 months
- •ECOG performance status > 2 (annex 3)
- •proven amyloidosis
- •positive HIV serology
- •antecedents of severe psychiatric disease
- •severe diabetes contraindicating the use of high-dose corticoïds
- •> NCI grade 2 peripheral neuropathy (Annex IV)
- •serum biochemical values as follow
- •creatinin level > 200mmol/l
- •bilirubin, transaminases or gGT > 3 the upper normal limit
- •use of any experimental drugs within 30 days of baseline
结局指标
主要结局
Complete remission after 4 cycles:
disappearance of serum and/or urine M-component (confirmed by immunofixation)
< 5% plasma cells in the bone marrow resolution of all extra-osseous plasmacytomas
no evidence of bone progression
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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