NCT01517724已完成2 期
Phase II Study of Bortezomib Consolidation After High Dose Therapy and Autologous Stem Cell Transplantation for Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Disease response
研究概览
简要总结
The aim of this trial is to determine whether bortezomib improves response and delays progression for multiple myeloma patients after high dose therapy and autologous stem cell transplant. It will also assess the effect of bortezomib treatment on patient bone health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MM patients who have received high dose Melphalan with ASCT 3-4 months prior to registration and have not progressed
- •Age 18 - 70 years
- •Life expectancy > 6 months
- •Written informed consent
- •Creatinine < 400µmol/L
- •Bilirubin < 3x upper limit of normal
- •WHO performance status 0-2
- •Contraceptive precautions where appropriate
排除标准
- •Received bortezomib previously
- •On, or planned for, steroid therapy
- •Poor performance status (ECOG ≥ 3)
- •Disease progression at any stage
- •Past history of polio, cord compression or other neurological condition resulting in persisting neurological deficit ≥ grade 2
- •Severe hepatic impairment, indicated by bilirubin ≥ 3x upper limit of normal, or AST > 2.5x upper limit of normal
- •Pregnant or lactating women
- •Allergic reaction attributable to bortezomib or to compounds containing boron or mannitol
- •Severe cardiovascular disease
- •History of acute infiltrative pulmonary or pericardial disease
- •History of hypotension or has decreased blood pressure
- •Peripheral neuropathy ≥ grade 2, or neuropathic pain
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Received any drugs or agents that inhibit or induce CYP2C19 or CYP3A4 within 14 days before the first dose of bortezomib
- •Need for therapy with concomitant CYP 3A4 or CYP2C19 inhibitors
- •Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment
研究组 & 干预措施
Bortezomib consolidation
Experimental
Bortezomib administered once a week 1.3mg/sq m; maximum of 8 cycles (each cycle is 4 weeks)
干预措施: Bortezomib (Drug)
结局指标
主要结局
Change in Disease response
时间窗: At 6 and 12 months after ASCT consolidated by bortezomib therapy
Disease response prior to consolidation with bortezomib will be compared with disease response at 6 and 12 months post ASCT.
Number of patients with adverse events
时间窗: Up to 8 months after treatment start
The number and percentage of patients who experience adverse events related to bortezomib treatment will be summarised for patients who received bortezomib consolidation after ASCT
次要结局
- assess effect of bortezomib consolidation on bone health(At 1, 2, 3 and 9 months after start of treatment)
- assess the effect of bortezomib consolidation on Minimal Residue Disease status(At 6 and 12 months post ASCT)
- determine progression free survival(At 2 years post ASCT)
- evaluate the quality of life for patients receiving bortezomib consolidation(Up to 8 months after treatment start)
研究者
研究点 (1)
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