跳至主要内容
临床试验/NCT02884102
NCT02884102进行中(未招募)不适用

Clinical-grade Molecular Profiling of Patients With Multiple Myeloma and Related Plasma Cell Malignancies

Multiple Myeloma Research Foundation20 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
20
主要终点
actionable mutations report

研究概览

简要总结

This protocol is now being used as screening for the MyDRUG study

详细描述

Here we propose an "integrative sequencing approach" utilizing a 1500 gene exome comparative analysis between multiple myeloma or related plasma cell malignancies and normal cells coupled to capture transcriptome sequencing to provide a nearly comprehensive landscape of the genetic alterations for the purpose of identifying informative and/or actionable mutations in patients with multiple myeloma and plasma cell malignancies. The approach will enable the detection of point mutations, insertions/deletions, gene fusions and rearrangements, amplifications/deletions, and outlier expressed genes among other classes of alterations.

研究设计

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

入排标准

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

入选标准

  • Patients must have a diagnosis of multiple myeloma or related malignancy
  • Patients are undergoing standard of care bone marrow aspirates
  • Patients (male or female) from any race or ethnicity must be at least 18 years of age at the time of registration.
  • Procedure-specific signed informed consent form prior to initiation of any study-related procedures.

排除标准

  • It is the enrolling study physician's discretion to decide if a patient is not fit enough to undergo a bone marrow aspirate.
  • Patients who are incarcerated are not eligible to participate.
  • Women who are pregnant
  • Patients who have had another malignancy within the last five (5) years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) where there is a possibility to contaminate the bone marrow aspirate.

结局指标

主要结局

actionable mutations report

时间窗: 10-14 days

次要结局

  • Disease Recurrence(Time to Progression)
  • Survival Rates(Overall survival)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

Loading locations...

相似试验