Phase 0 Microdose Study to Evaluate the Effect of Melphalan, Bortezomib and Dexamethasone on Cellular Gene-expression in Patients With Multiple Myeloma
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.
研究概览
简要总结
The purpose of the study is to identify specific genes that are up- or downregulated in multiple myeloma patients who receive a microdose of either Melphalan (Alkeran®), Bortezomib (Velcade®) or Dexamethasone (Dexaven®). The study treatment constitutes 1% of the planned standard myeloma treatment and will be given two hours prior to standard treatment. Blood samples are taken at baseline, 15, 30, 60 and 120 minutes for microarray analysis.
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
- Basic Science
- 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
- •Planned treatment for Multiple Myeloma (newly diagnosed as well as relapse and refractory disease) with one of the following chemotherapy regimens: 1) Highdose melphalan, 2) Bortezomib or 3) Dexamethasone
- •18 years or older.
- •Understand and have the will to sign the informed consent.
排除标准
- •Prior treatment with the study drug
- •Received treatment with biphosphonates in the week prior to study treatment
研究组 & 干预措施
Melphalan
A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
干预措施: Melphalan (Drug)
Bortezomib
A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
干预措施: Bortezomib (Drug)
Dexamethasone
A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Change from baseline in gene expression at 15, 30, 60, 120 minutes upon microdose drug exposure.
时间窗: Prior to microdose and 15, 30, 60 and 120 minutes post-microdose
The primary outcome measure is determination of differential and significantly expressed genes across time successive samples from each individual patient. The analysis will be based on global gene expression profiling and differentially expressed genes will be identified using pairwise comparisons of samples means by two sample t-tests and corrections for multiple testing.
次要结局
未报告次要终点
研究者
Henrik Gregersen
Consultant haematologist, MD, PhD
Aalborg University Hospital