Thalidomide-Dexamethasone Incorporated Into Double Autologous Stem-Cell Transplantation for Patients Less Than 65 Years of Age With Newly Diagnosed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 378
- 主要终点
- Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction
研究概览
简要总结
The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory multiple myeloma (MM) provided the basis for this phase 2 clinical study aimed at investigating the efficacy and toxicity of thal-dex incorporated into melphalan-based double autologous stem cell transplantation (ASCT)for patients less than 65 years old with newly diagnosed symptomatic MM. Thal-dex was given as primary induction therapy and was then continued throughout the subsequent treatment phases until the day before the second autotransplantation. Primary study endpoints,as evaluated on an intention to treat basis, are response rates to the different treatment phases (induction, first and second ASCT), best response whenever achieved, duration of response (DOR), time to progression (TTP), progression free survival (PFS)and toxicity profile of thal-dex. Secondary endpoints, as evaluated on an intention to treat basis, are overall survival (OS) and clinical outcomes (DOR, TTP, PFS and OS)according to prognostic factors, including cytogenetic abnormalities and imaging features, as detected by 18F-FDG PET/CT.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Response rate (at least PR, VGPR, nCR and CR) to thal-dex induction
时间窗: 120 days after the start day of tal-dex induction therapy
Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
duration of response (partial response, PR, very good partial response, VGPR, complete response, CR)
时间窗: Average time period between the day of first achievement of response and the day of first relapse or progression
Duration of response is calculated from the first achievement of the response (at least PR, at least VGPR, at least CR) to relapse/progression
time to progression (TTP)
时间窗: Average time period between the start day of induction therapy and the day of relapse or progression
TTP is calculated from the start date of induction therapy to the date of relapse/progression
progression free survival (PFS)
时间窗: Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly
PFS is calculated from the start date of induction therapy to the date of relapse/progression or death for any cause, whichever occurs first
toxicity of thal-dex (induction and subsequent treatment phases)
时间窗: Within 30 days after the last dose of study drug
Adverse events are assessed monthly and graded according to the National Cancer Institute Common Toxicity Criteria, version 2. Safety is monitored until 30 days after the last dose of study drug.
Response rate (at least PR, VGPR, nCR and CR) to first ASCT
时间窗: 90 days after first ASCT
Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
Response rate (at least PR, VGPR, nCR and CR) to second ASCT
时间窗: 90 days after second ASCT
Responses are reported by study investigators and centrally reassessed by study coordinator(s). Criteria are those initially proposed by the European Group for Blood and Marrow Transplantation (EBMT), with the addition of nCR (100% M-protein reduction by electrophoresis, but immunofixation-positive)and VGPR (at least 90% reduction of M component).
次要结局
- Overall survival (OS)(Average time period between the start day of induction therapy and the day of death, due to any cause)
- OS by cytogenetic abnormalities(Average time period between the start day of induction therapy and the day of death, due to any cause)
- OS by 18F-FDG PET/CT imaging(Average time period between the start day of induction therapy and the day of death, due to any cause)
- TTP by cytogenetic abnormalities(Average time period between the start day of induction therapy and the day of relapse or progression)
- PFS by cytogenetic abnormalities(Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly)
- TTP by 18F-FDG PET/CT imaging(Average time period between the start day of induction therapy and the day of relapse or progression)
- PFS by 18F-FDG PET/CT imaging(Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly)