Full Title:: The Terry Fox Pan-Canadian Multiple Myeloma Molecular Monitoring Study

Myeloma stage or condition:: Multiple Myeloma

Study phase:

Summary/Purpose:: 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.

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.

Treatments:

Study Arms:

Study Type:: Observational

Study Design:: Observational Model: Cohort; Time Perspective: Prospective

Recruitment status:: Active, not recruiting

Eligibility criteria:

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

Locations / Centres:

Tom Baker Cancer Centre, Calgary, Alberta – ()

Cross Cancer Institute, Edmonton, Alberta – ()

Vancouver General Hospital, Vancouver, British Columbia – ()

CancerCare Manitoba, Winnipeg, Manitoba – ()

Saint John Regional Hospital (Horizon Health Network), Saint John, New Brunswick – ()

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia – ()

Buland Mangukia, Hamilton, Ontario – ()

Princess Margaret Cancer Centre, Toronto, Ontario – ()

McGill University Health Centre, Montréal, Quebec – ()

Contacts:: Not available

Publications:: ???

First posted:: 2018-02-05

Actual start date:: February 20, 2018

Last updated:: 2024-02-27

Estimated enrollment:: 96

Estimated completion date:: 2026-03-31

Estimated primary completion date:: 2024-12-31

Condition:: Multiple Myeloma

Gender:: All

Ages:: 19 Years-99 Years

Accepts healthy volunteers:: No

Listed location countries:: Canada

NCT number:: NCT03421132

Other study ID numbers:: M4

Has Data monitoring committee:: No

U.S. FDA-regulated product:: No

IPD Sharing Statement :: ???

Responsible party:: Principal Investigator
Horizon Health Network
Dr. Anthony Reiman
Principal Investigator

Study sponsor:: lead_sponsor
Horizon Health Network
Other

Collaborators:: ???

Investigators:: Anthony J Reiman, MD Horizon Health Network

Protocol Registration and Results System:: ???

Verification date:: 2024-02-01

Multiple Myeloma Molecular Monitoring Study (M4)