NCT02197221已完成3 期
IFM 2014-02 Study: A Randomized Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 46
- 主要终点
- Complete Response rates (according to IMWG 2011 criteria)
研究概览
简要总结
Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have results from their initial diagnosis available at the time of screening to confirm all the following :
- •Diagnosis of multiple myeloma according to the diagnostic
- •Symptomatic de novo Multiple Myeloma
- •Be eligible for high-dose therapy with autologous stem cell transplantation
- •Autologous cell graft with a total number of CD 34 cells > or = 5 X 106/kg before freezing
排除标准
- •Progressive disease
- •Females participants pregnant or breast-feeding
- •A known infection by the human immunodeficiency virus
- •An active viral hepatitis B or C
- •Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker
- •Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment
- •A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator
- •A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment
研究组 & 干预措施
Bortezomib-Melphalan
Experimental
Bortezomib will be administered on days: -6, -3 +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
干预措施: Bortezomib-Melphalan (Drug)
Melphalan
Active Comparator
Melphalan will be administered on day -2. The PBSC will be injected on day 0.
干预措施: Melphalan (Drug)
结局指标
主要结局
Complete Response rates (according to IMWG 2011 criteria)
时间窗: 60 days post Autologous Stem Cells Transplantation
overall survival
时间窗: 60 months
次要结局
- progression-free survival between the two arms(60 months)
- Response rates (according to IMWG 2011 criteria)(post ASCT and consolidation therapy)
- Serious adverse event(End of study)
研究者
研究点 (46)
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