Thalidomide-Cyclophosphamide-Dexamethasone in Patients < 75 Years or Velcade-Melfalan-Prednisone (V-MP)/Thalidomide-Cyclophosphamide-Dexamethasone in Patients >75 Years, in Refractary or Relapsed Multiple Myeloma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Efficacy of a sequential scheme treatment with Bortezomib, Melfalan,Prednisone (V-MP) or Bortezomib, Adriamycine, Melfalan,Prednisone (VAMP) followed by Thalidomide, Cyclophosphamide and Dexamethasone (TaCyDex) in relapsed or refractory MM patients
研究概览
简要总结
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.
详细描述
Multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with Bortezomib in combination with Melfalan and Prednisone (V-MP) (patients > 75 years) or Bortezomib and Adriamycine in combination with Melfalan and Prednisone (VAMP) (patients <= 75 years) follow by Thalidomide in combination with Cyclophosphamide and Dexamethasone (TaCyDex) in patients with refractary or relapse multiple myeloma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with refractary or relapsed multiple myeloma
- •Life expectancy > 3 months
- •Neutrophils account ≥ 0.5 X 10^9/L, platelets ≥ 30 X 10^9/L.
- •Transaminases <3 times upper normal limit, bilirubin < 2 times upper normal limit
- •Age > 18 years
- •Time after last chemotherapy or radiotherapy > 1 month or time after transplantation > 2 months.
- •No possible other actual treatment
- •Written consent form
排除标准
- •Candidate to second transplantation
- •No following criteria
- •Other neoplasties
- •Peripheral neuropathy > Grade
- •Previous ileus paralytic
- •Hepatic failure
- •No controlled infection
- •No controlled high calcium levels
- •Any organic insufficiency that no permit follow the correct treatment
- •Pregnancy, breast feeding or fertility without anticonceptive method
- •Any psychological, social and/or familiar event that no permit follow the correct treatment
- •Diabetes mellitus not controled
研究组 & 干预措施
1
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
干预措施: Bortezomib (Drug)
1
Induction: 6 alternating cycles Bortezomib-Melfalan-Prednisone or Bortezomib- Adriamycine-Melfalan-Prednisone and Thalidomide-Cyclophosphamide-Dexamethasone, followed by other 6 maintenance cycles
干预措施: Thalidomide (Drug)
结局指标
主要结局
Efficacy of a sequential scheme treatment with Bortezomib, Melfalan,Prednisone (V-MP) or Bortezomib, Adriamycine, Melfalan,Prednisone (VAMP) followed by Thalidomide, Cyclophosphamide and Dexamethasone (TaCyDex) in relapsed or refractory MM patients
时间窗: 1 year
次要结局
- Evaluate the response type in function to different initial situation (primary resistance, relapse, progression)(1 year)
- To analyze the response duration(2 years)