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