Bortezomib in Combination With Continuous Low-dose Oral Cyclophosphamide and Dexamethason Followed by Maintenance in Primary Refractory or Relapsed Bortezomib naïve Multiple Myeloma Patients. A Prospective Phase II Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Toxicity of induction chemotherapy according to CTCAE version 3.0
研究概览
简要总结
Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide, also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a myeloma functionality.
The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects. Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Stage II-III Multiple Myeloma
- •Relapse or primary refractory disease after initial chemotherapy
- •WHO performance status 0 - 2
- •Life expectancy of at least 6 weeks
- •ANC (absolute neutrophil count) ≥ 1.0x109/l(or ≥ 0.5x109/l, if due to bone marrow infiltration by malignancy)
- •Platelet count ≥ 75x109/l or ≥ 50x109/l, if due to bone marrow infiltration by malignancy)
- •Written informed consent (present in patient's file)
- •Patient is able and willing to use adequate contraception during therapy and for at least 1 month after study
- •Patient has the ability to understand the requirements of the study
排除标准
- •Previous treatment with bortezomib
- •Urine production < 1.5 l/24h
- •Pre-existent polyneuropathy (grade 2 or higher, according to CTCAE 3.0)
- •Pregnancy or positive pregnancy tests during study and for 1 month after final dose of thalidomide
- •History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin)
- •Active uncontrolled infections
- •Additional uncontrolled serious medical or psychiatric illness
研究组 & 干预措施
Bortezomib, cyclophosphamide, dexamethason
- To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy.
- To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma.
干预措施: Bortezomib (Drug)
Bortezomib, cyclophosphamide, dexamethason
- To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy.
- To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma.
干预措施: Cyclophosphamide (Drug)
Bortezomib, cyclophosphamide, dexamethason
- To assess the efficacy of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy.
- To assess the safety of bortezomib, cyclophosphamide and dexamethasone during re-induction and in maintenance therapy in patients with refractory or relapsed multiple myeloma.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Toxicity of induction chemotherapy according to CTCAE version 3.0
时间窗: 5 years
次要结局
- Overall Survival(5 years)
- Progression Free Survival(5 years)
研究者
E. Vellenga
Prof.dr.
University Medical Center Groningen