跳至主要内容
临床试验/NCT05530096
NCT05530096招募中不适用

Detect and Profile Multiple Myeloma Measurable Residual Disease (MRD )Prognostics for Monitoring Post-transplant Multiple Myeloma (MM) Patients Receiving Maintenance Therapy.

Sir Mortimer B. Davis - Jewish General Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
To validate the sensitivity of Telo Genomics assay (measurement tool) to detect MRD (measurement expressed in the number of plasma cells per 100000 cells) and establish the clinical utility of TELO - DMRD for MRD enumeration

研究概览

简要总结

The purpose :

Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.

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

入选标准

  • Confirmed MM diagnosis
  • Transplant eligible patients in a first remission
  • Known MRD level detected by ClonoSeq (other IMWG recognized methodologies can be also employed)
  • Availability of deidentified patient's demographic and clinical follow up data
  • Receiving standard of care treatment
  • Able to provide informed consent

排除标准

  • Failure to meet inclusion criteria

结局指标

主要结局

To validate the sensitivity of Telo Genomics assay (measurement tool) to detect MRD (measurement expressed in the number of plasma cells per 100000 cells) and establish the clinical utility of TELO - DMRD for MRD enumeration

时间窗: Approximately 5 years

Assess the possibility to perform TELO-DMRD on bone marrow aspirate samples vs peripheral blood Validate TELO-DMRD results with ClonoSeq, as an IMWG recognized MRD assessment method (other IMWG recognized methodologies can be also employed)

To assess the utility of TeloView® technology genomic profiling (measurement tool) to stratify post-transplant MM patients into relapse risk groups (dichotomous measure of high or low) by analyzing the residual MRD plasma cells

时间窗: Approximately 5 years

o A longitudinal study including transplant eligible patients. Patients to be followed for 6 time points over 24 months at: At point of diagnosis (marrow aspirate \& peripheral blood), 4m post induction (peripheral blood), 3m Post-transplant (peripheral blood), at 12m Post-transplant (peripheral blood), 18m Post-transplant (peripheral blood) \& 24m Post-transplant (peripheral blood), and at point of relapse for patients who will relapse during the follow up time (marrow aspirate \& peripheral blood). Of note, an additional marrow aspirate may be performed if the patient agrees at the time they attain a complete remission, to confirm this status

次要结局

未报告次要终点

研究者

发起方
Sir Mortimer B. Davis - Jewish General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rayan Kaedbey

Principal Investigator

Sir Mortimer B. Davis - Jewish General Hospital

研究点 (1)

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