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临床试验/NCT01619358
NCT01619358Unknown不适用

Genomic-Based Diagnosis, Classification and Targeted Treatment of Multiple Myeloma

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Prospectively validate the use of gene expression profiling (GEP) for the risk-stratification and classification of MM

研究概览

简要总结

Multiple myeloma is an incurable bone marrow cancer characterized by an abnormal expansion of plasma cells that secretes monoclonal immunoglobulin. Over the years, the molecular and genetic heterogeneity of the disease have been dissected. With the maturation of technologies, the time is ripe now to apply genomics to diagnose, classify, risk-stratify and prognosticate myeloma in the clinical setting and use this information to guide current treatment. The investigators hypothesize that the use of gene expression profiling as a single test will be more economical, efficient and accurate compared to the current standard panel of tests done at diagnosis. The investigators also hypothesize that the investigator can use predictive markers to identify prospectively patients who will respond to Velcade and that with more effective trebasedonatment, ability to measure depth of response beyond conventional complete response become important since more patients are achieving conventionally determined complete response. Using a cohort of patients treated on a standard treatment protocol based on Velcade-based induction treatment followed by consolidation and maintenance treatment, the investigators will study specifically the feasibility and accuracy of gene expression diagnostics, the predictive power of the investigators predefined predictive markers and the clinical utility of minimal residual disease measurement in myeloma. The results of the investigators study will allow us to improve the diagnosis, and prognostication of MM patients

  1. The investigators hypothesized that this will speed up diagnosis, provide comprehensive information for the classification and risk stratification of MM patients and can completely replace the current FISH assay and may be cheaper.
  2. The investigators hypothesized that TRAF3 deletion or mutation and MYC activation will identify patients that will have a significantly better response to Velcade.
  3. Modern treatment induced deeper response. More sensitive method of disease detection will allow us to know the fully extent of response to these treatment

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Patients fulfilling IMWG diagnostic criteria for myeloma

排除标准

  • Unable to take consent

结局指标

主要结局

Prospectively validate the use of gene expression profiling (GEP) for the risk-stratification and classification of MM

All patients will have additional bone marrow taken for GEP studies after informed consent at entry into the treatment protocol. CD138 positive cells will be selected using magnetic beads and RNA extracted. The quality of RNA will be checked using the Agilent Bioanalyzer. GEP will be performed using Affymetrix U133plus2.0 chip.

次要结局

  • Prospectively validate predictive biomarkers in MM
  • Study the impact of different treatment phases on minimal residual disease (MRD) and their impaction outcome.

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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