Official Title
The Terry Fox Pan-Canadian Multiple Myeloma Molecular Monitoring Study
Summary:
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.
Trial Description
Primary Outcome:
- Sensitivity of Minimal Residual Disease (MRD) Assays
- Sensitivity of Minimal Residual Disease (MRD) Assays
Secondary Outcome:
- Comparison of Sensitivity of MRD Assays with PET scans
- Predicting Progression-Free Survival Using MRD Assessment
- Predicting Overall Survival Using MRD Assessment
- Quality-Adjusted Life Years (QALYs) Gained
- Incremental Cost-Effectiveness of MRD Testing
- Productivity Costs Associated with MRD Testing
- Multiple Myeloma Patients' Quality of Life (QOL)
- Correlative Study: Sensitivity and Specificity of Drug Resistance Assays
- Correlative Study: Circulating Tumour DNA
- Correlative Study: Describing Myeloma Progenitor Populations
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.
View this trial on ClinicalTrials.gov
