M4: Multiple Myeloma Molecular Monitoring Study

Sponsor
Horizon Health Network (Other)
Overall Status
Recruiting
CT.gov ID
NCT03421132
Collaborator
(none)
250
13
79.3
19.2
0.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Terry Fox Pan-Canadian Multiple Myeloma Molecular Monitoring Study
    Actual Study Start Date :
    Feb 20, 2018
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    Sep 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Sensitivity of Minimal Residual Disease (MRD) Assays [100 days post-treatment]

      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.

    2. Sensitivity of Minimal Residual Disease (MRD) Assays [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.

    Secondary Outcome Measures

    1. Comparison of Sensitivity of MRD Assays with PET scans [12 months post-maintenance therapy]

      Comparison of the sensitivity of two MRD assays - (1) multiparameter flow cytometry (MFC), and (2) immunoglobulin gene sequencing (IgS) - with (3) positron emission tomography (PET) imaging scans, in order to determine if PET scans offer additional information above and beyond that offered through the two assays.

    2. Predicting Progression-Free Survival Using MRD Assessment [5 years]

      Establish the prognostic significance of MRD assessment (i.e., the two MRD assays, and PET scans) on progression-free survival

    3. Predicting Overall Survival Using MRD Assessment [5 years]

      Establish the prognostic significance of MRD assessment (i.e., the two MRD assays, and PET scans) on overall survival

    4. Quality-Adjusted Life Years (QALYs) Gained [5 years]

      To fully understand health care costs and benefits associated with personalized risk-adapted testing and monitoring strategies for cancer, compared to current standard of care (e.g., non-personalized), the investigators will create a model that includes cohort's responses on patient-reported health status (using the EuroQol-5D or EQ-5D-L) and use of healthcare resources (using the NCIC Resource Utilization Form), and that will calculate quality-adjusted life years of the participants.

    5. Incremental Cost-Effectiveness of MRD Testing [5 years]

      To fully understand health care costs and benefits associated with personalized risk-adapted testing and monitoring strategies for cancer, compared to current standard of care (e.g., non-personalized), the investigators will create a model that includes cohort's responses on patient-reported health status (using the EuroQol-5D or EQ-5D-L) and use of healthcare resources (using the NCIC Resource Utilization Form), and that will calculate the cost-effectiveness of the MRD assays under investigation.

    6. Productivity Costs Associated with MRD Testing [5 years]

      To fully understand health care costs and benefits associated with personalized risk-adapted testing and monitoring strategies for cancer, compared to current standard of care (e.g., non-personalized), the investigators will create a model that includes cohort's responses on patient-reported health status (using the EuroQol-5D or EQ-5D-L) and use of healthcare resources (using the NCIC Resource Utilization Form), and that will calculate the individual and system-level productivity costs associated with the MRD assays under investigation.

    7. Multiple Myeloma Patients' Quality of Life (QOL) [5 years]

      The investigators will evaluate patients' QOL, especially how it is impacted by treatment, disease and patient characteristics, using a common self-report measure (European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire, or EORTC-QLQ-30). Specific outcomes include QOL at each time point in the study and overall for the cohort, comparing those who achieve MRD and those who do not.

    8. Correlative Study: Sensitivity and Specificity of Drug Resistance Assays [5 years]

      The investigators will also investigate sensitivity and specificity of assays of drug resistance (e.g., why this cancer eventually becomes resistant to the drugs used to treat it)

    9. Correlative Study: Circulating Tumor DNA [5 years]

      The investigators will also investigate prognostic significance of circulating tumour (ct) DNA profiles

    10. Correlative Study: Describing Myeloma Progenitor Populations [5 years]

      The investigators will also seek to understand how the cancer recurs and regrows, even for those who achieve an MRD state.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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)

    Exclusion Criteria:
    • Ineligible for ASCT

    • Does not consent to participate in MCRN database project

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    2 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    3 Vancouver General Hospital Vancouver British Columbia Canada V5Z 1M9
    4 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    5 Saint John Regional Hospital (Horizon Health Network) Saint John New Brunswick Canada E2L 4L5
    6 Queen Elizabeth II Health Sciences Centre Halifax Nova Scotia Canada B3H 2Y9
    7 Juravinski Cancer Centre Hamilton Ontario Canada L8V 1C3
    8 The Ottawa Hospital Ottawa Ontario Canada K1H 8L6
    9 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 1X6
    10 CIUSSS de l'Est-de-l'Île-de-Montréal (Maisonneuve-Rosemount) Montréal Quebec Canada H1T 2M4
    11 McGill University Health Centre Montréal Quebec Canada H4A 3J1
    12 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    13 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • Horizon Health Network

    Investigators

    • Principal Investigator: Anthony J Reiman, MD, Horizon Health Network

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Dr. Anthony Reiman, Principal Investigator, Horizon Health Network
    ClinicalTrials.gov Identifier:
    NCT03421132
    Other Study ID Numbers:
    • M4
    First Posted:
    Feb 5, 2018
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 22, 2022