Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 主要终点
- Number of patients with event-free survival (PFS)
研究概览
简要总结
The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.
详细描述
This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation
- •Women must be postmenopausal or using safe contraception methods
- •Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges
排除标准
- •No asecretory multiple myeloma
- •History of allergic reactions to bortezomib or mannitol
- •Expected life expectancy of less than 3 months
- •No other malignant disease beside basalioma either existing or history of
- •No history of severe cardio-pulmonary disease
研究组 & 干预措施
Treatment group
Participants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.
干预措施: Bortezomib (Drug)
Observation group
Participants in the observation group will not receive any consolidation therapy.
干预措施: No intervention (Drug)
结局指标
主要结局
Number of patients with event-free survival (PFS)
时间窗: From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled
次要结局
- Number of patients with event free survival (EFS)(From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled)
- Number of patients with toxicities over the treatment period(Up to Week 24)
- Response rates(Up to Week 25)
- Overall survival(From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled)
- Time to progression(From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled)
- Duration of response(Up to Week 25)
- Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30)(Baseline (Day 1), Enpoint (30-60 months))
- Number of the patients with skeletal related event (SRE)(Up to 30-60 months)
- Time interval from the day of the transplantation up to the occurrence of the first SRE(Up to 30-60 months)
- Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to end point (30-60 months)(Baseline (Day 1) and end point (30-60 months))