Assessment of Molecular Remission by ASO-RQ-PCR Technique After Induction Treatment With Bortezomib-dexamethasone (Vel/Dex) Followed by HDT With ASCT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
研究概览
简要总结
The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.
详细描述
HDT-ASCT is so far considered the standard of care for younger patients with multiple myeloma (MM). Current evidence indicates that quality of response is an important prognostic factor for long-term survival in MM. There are only very few data on molecular remissions (MolR) determined by the most sensitive technique, allele-specific-oligonucleotide - real-time quantitative - polymerase chain reaction (ASO-RQ-PCR) in MM, and there are no data available on molecular responses after bortezomib-based induction therapy followed by HDT-ASCT. The main aim of this study is to determine molecular response rate after ASCT following bortezomib-based induction treatment compared to a historical control group with conventional VAD induction treatment. A sensitivity of ASO-RQ-PCR technique will be compared to immunofixation and with immunophenotyping by flow cytometry.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic multiple myeloma
- •Age 18-65 years
- •Written informed consent
排除标准
- •WHO performance status ≥ 2, unless related to MM
- •Severe cardiac dysfunction
- •History of hypotension
- •Serious medical or psychiatric illness
- •Severe hepatic dysfunction
- •Severe polyneuropathy ≥ grade 2
- •Active, uncontrolled infection
- •Previously treated with chemotherapy or extensive radiotherapy for MM
- •Known HIV positivity
- •Severe renal dysfunction with need of dialyses
- •History of active cancer during past 5 years, except non-melanoma skin cancer or stage 0 cervical cancer
- •Female patients who are pregnant or nursing
- •Male or female patients of reproductive potential who are not practising effective means of contraception
研究组 & 干预措施
Vel/Dex
干预措施: bortezomib + dexamethasone (Drug)
结局指标
主要结局
Molecular remission after Vel/Dex induction (4 cycles) and 3-4 months after ASCT in those patients receiving CR or nCR
时间窗: Before ASCT and 3-4 months after ASCT and then with 3-4 months interval
次要结局
未报告次要终点