Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 18
- 主要终点
- Change in treatment intention
研究概览
简要总结
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
详细描述
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.
Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.
A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Potentially multiple myeloma according to IMWG criteria
- •Candidates for systemic treatment
排除标准
- •ECOG Performance Status > 3
- •Tumor sample that fails QA or QC criteria for MMprofiler
研究组 & 干预措施
MMprofiler SKY92
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
干预措施: MMprofiler SKY92 gene signature (Device)
结局指标
主要结局
Change in treatment intention
时间窗: Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler
Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment
次要结局
- 5 year Progression Free Survival(5 years after diagnosis)
- 5 year Overall Survival(5 years after diagnosis)
- 3 year Overall Survival(3 years after diagnosis)
- 3 year Progression Free Survival(3 years after diagnosis)