Superiority of the Triple Combinations of Bortezomib, Cyclophosphamide and Dexamethasone (VCD) Versus Cyclophosphamide, Thalidomide and Dexamethasone (CTD) in Patients With Newly Diagnose Multiple Myeloma, Eligible for Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 311
- 主要终点
- Response rate better than very good partial response after 4 induction cycles
研究概览
简要总结
This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.
详细描述
The primary aim was observe response rate after 4 induction cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose >18yo
排除标准
- •other chemotherapy induction protocol
研究组 & 干预措施
Vcd- (Bortezomibe, cyclophosphamide and dexamethasone)
Intervention - Bortezomib 1.3mg/m2 Intra venous or Subcutaneous once a week (D1-8-15-22) 35days cycle Intervention- Dexamethasone 40mg once a week for four weeks orally or Intravenously- total dose per cycle was 160mg.
Intervention- Cyclophosphamide 900-2000mg- intravenously or orally- total dose monthly Total of four cycles
干预措施: Bortezomib, cyclophosphamide, thalidomide, dexamethasone (Drug)
Ctd- Cyclophosphamide, thalidomide and dexamethasone
Intervention- Cyclophosphamide 900-2000mg intravenously or orally total dose monthly Intervention- Thalidomide 100-200mg orally- daily dose Intervention -Dexamethasone 40mg once a week for four weeks each month- total dose per cycle was 160mg Total of four cycles (cycles of 28 each one)
28 days each cycles- total of four cycles
干预措施: Bortezomib, cyclophosphamide, thalidomide, dexamethasone (Drug)
结局指标
主要结局
Response rate better than very good partial response after 4 induction cycles
时间窗: Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
The primary outcome is to observe the difference response rate between VCD and CTD induction myeloma elegible patient
次要结局
未报告次要终点
研究者
Vania TM Hungria
Assintant Professor of Hematology oncology- Santa Casa de Sao Paulo Medical School
Grupo de Estudos Multicentricos em Onco-Hematologia