The Terry Fox Pan-Canadian Multiple Myeloma Molecular Monitoring Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 9
- 主要终点
- Sensitivity of Minimal Residual Disease (MRD) Assays
研究概览
简要总结
The investigators will track 250 multiple myeloma patients across Canada over time, using new lab tests to evaluate their blood and bone marrow, as they receive standard of care treatment. The main hypothesis is that these tests will allow clinicians to better diagnose and manage multiple myeloma, improving patients' quality of life overall.
详细描述
Multiple myeloma (MM) is a deadly cancer of the bone marrow that is challenging to manage and treat: the drugs that are currently available attack the cancer in the same way for everyone, but each patient has different types of MM cancer cells and different family traits that predict better or worse outcomes. As well, the ways in which clinicians test to see if the cancer is in remission are not very good at detecting small numbers of cancer cells still in the bone marrow after treatment - and which will, sooner or later cause the patient to get sick again. The goal of the M4 study is to improve MM patients' survival and quality of life over time, by finding better ways of a) characterizing each patient's experience with the disease, and b) identifying and tracking the small numbers of cells that remain after treatment.
The investigators plan to track 250 patients across Canada over time, who are getting treatment for multiple myeloma. While they are getting treatment, the research team will evaluate samples of their blood and bone marrow with newer, more precise laboratory tests. Participants will also be asked to take part in two scans of their bodies during their treatment. The investigators hypothesize that these tests can help clinicians make better treatment recommendations to patients.
The investigators will look at whether one test is better than another, or if a combination of these tests is needed to have the best information possible to make treatment decisions. At the same time, the research will also explore how and why some patients' cancer becomes resistant to the treatments over time, and how myeloma cells are able to start growing again after treatment. The research team will also collect information on how each patient's health and quality of life changes during and after treatment, and what are the associated costs with these new approaches - to both the healthcare system overall, and to patients.
Once the five-year research program is complete, it is hoped that clinicians will have a new, proven and affordable process of combining these new laboratory tests with the current clinical approach, to create new options to evaluate and treat multiple myeloma.
It is the overall goal that this research will make a difference, right away and across the world, in how doctors treat multiple myeloma, in how it is studied by scientists, and in how patients advocate for their own healthcare.
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
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent
- •Diagnosed with active multiple myeloma
- •Consented to participation in Myeloma Canada Research Network (MCRN) database project
- •Previously untreated and eligible for autologous stem-cell transplantation (ASCT)
排除标准
- •Ineligible for ASCT
- •Does not consent to participate in MCRN database project
结局指标
主要结局
Sensitivity of Minimal Residual Disease (MRD) Assays
时间窗: 12 months post-maintenance therapy
Comparison of the sensitivity of two leading-edge MRD assays - (1) multiparameter flow cytometry (MFC), and (2) immunoglobulin gene sequencing (IgS) - in patients who meet the conventional definition of complete remission post-treatment.
次要结局
- Incremental Cost-Effectiveness of MRD Testing(5 years)
- Correlative Study: Circulating Tumor DNA(5 years)
- Predicting Overall Survival Using MRD Assessment(5 years)
- Correlative Study: Sensitivity and Specificity of Drug Resistance Assays(5 years)
- Comparison of Sensitivity of MRD Assays with PET scans(12 months post-maintenance therapy)
- Productivity Costs Associated with MRD Testing(5 years)
- Predicting Progression-Free Survival Using MRD Assessment(5 years)
- Quality-Adjusted Life Years (QALYs) Gained(5 years)
- Multiple Myeloma Patients' Quality of Life (QOL)(5 years)
- Correlative Study: Describing Myeloma Progenitor Populations(5 years)
研究者
Dr. Anthony Reiman
Principal Investigator
Horizon Health Network