Multiple Myeloma Molecular Monitoring Study (M4)
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ClinicalTrials.gov Identifier: NCT03421132 |
Recruitment Status :
Recruiting
First Posted : February 5, 2018
Last Update Posted : February 11, 2020
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Condition or disease |
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Multiple Myeloma |
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 Type : | Observational |
Estimated 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 : | February 20, 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | June 2023 |

- Sensitivity of Minimal Residual Disease (MRD) Assays [ Time Frame: 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.
- Sensitivity of Minimal Residual Disease (MRD) Assays [ Time Frame: 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.
- Comparison of Sensitivity of MRD Assays with PET scans [ Time Frame: 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.
- Predicting Progression-Free Survival Using MRD Assessment [ Time Frame: 5 years ]Establish the prognostic significance of MRD assessment (i.e., the two MRD assays, and PET scans) on progression-free survival
- Predicting Overall Survival Using MRD Assessment [ Time Frame: 5 years ]Establish the prognostic significance of MRD assessment (i.e., the two MRD assays, and PET scans) on overall survival
- Quality-Adjusted Life Years (QALYs) Gained [ Time Frame: 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.
- Incremental Cost-Effectiveness of MRD Testing [ Time Frame: 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.
- Productivity Costs Associated with MRD Testing [ Time Frame: 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.
- Multiple Myeloma Patients' Quality of Life (QOL) [ Time Frame: 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.
- Correlative Study: Sensitivity and Specificity of Drug Resistance Assays [ Time Frame: 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)
- Correlative Study: Circulating Tumor DNA [ Time Frame: 5 years ]The investigators will also investigate prognostic significance of circulating tumour (ct) DNA profiles
- Correlative Study: Describing Myeloma Progenitor Populations [ Time Frame: 5 years ]The investigators will also seek to understand how the cancer recurs and regrows, even for those who achieve an MRD state.
Biospecimen Retention: Samples With DNA
Human Peripheral Blood: DNA, RNA and WBC.
Human Bone Marrow: DNA, RNA, WBC, CD138 positive and CD138 negative cells.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421132
Contact: Nicole Barry, MA | 506-648-6902 | nicole.barry@horizonnb.ca |
Canada, Alberta | |
Tom Baker Cancer Centre | Recruiting |
Calgary, Alberta, Canada, T2N 4N2 | |
Contact: Edith Nsangou 403-521-3889 Edith.Nsangou@albertahealthservices.ca | |
Principal Investigator: Nizar Bahlis, MD | |
Cross Cancer Institute | Recruiting |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Contact: Zack Breckenridge 780-667-6729 zackaria@ualberta.ca | |
Principal Investigator: Christopher Venner, MD | |
Canada, British Columbia | |
Vancouver General Hospital | Not yet recruiting |
Vancouver, British Columbia, Canada, V5Z 1M9 | |
Contact: Fareeha Khan 604-875-4111 ext 22966 Fareeha.khan1@bccancer.bc.ca | |
Principal Investigator: Kevin Song, MD | |
Canada, Manitoba | |
CancerCare Manitoba | Recruiting |
Winnipeg, Manitoba, Canada, R3E 0V9 | |
Contact: Darlene Zwarych 204-787-8805 Dzwarych@cancercare.mb.ca | |
Principal Investigator: Rami Kotb, MD | |
Canada, New Brunswick | |
Saint John Regional Hospital (Horizon Health Network) | Recruiting |
Saint John, New Brunswick, Canada, E2L 4L5 | |
Contact: Nicole Barry, MA 506-648-6902 Nicole.Barry@HorizonNB.ca | |
Contact: Bryn Robinson, PhD 506-649-2649 bryn.robinson@horizonnb.ca | |
Principal Investigator: Anthony Reiman, MD | |
Canada, Nova Scotia | |
Queen Elizabeth II Health Sciences Centre | Recruiting |
Halifax, Nova Scotia, Canada, B3H 2Y9 | |
Contact: Nova Lee Horne 902-473-7349 NovaLee.Horne@nshealth.ca | |
Contact: Blaine Gallant 902-473-7349 Blaine.Gallant@nshealth.ca | |
Principal Investigator: Darrell White, MD | |
Canada, Ontario | |
The Ottawa Hospital | Not yet recruiting |
Ottawa, Ontario, Canada, K1H 8L6 | |
Contact: Lynne Cullen 613-737-8899 ext 73952 lycullen@ohri.ca | |
Principal Investigator: Arleigh McCurdy, MD | |
Princess Margaret Cancer Centre | Recruiting |
Toronto, Ontario, Canada, M5G 1X6 | |
Contact: Harminder Paul 416-946-2317 Harminder.Paul@uhnresearch.ca | |
Principal Investigator: Donna Reece, MD | |
Canada, Quebec | |
CIUSSS de l'Est-de-l'Île-de-Montréal (Maisonneuve-Rosemount) | Recruiting |
Montréal, Quebec, Canada, H1T 2M4 | |
Contact: Nathalie Lachapelle 514-252-3400 ext 4471 nlachapelle.hmr@ssss.gouv.qc.ca | |
Principal Investigator: Richard LeBlanc, MD | |
Sub-Investigator: Jean Roy, MD | |
Sub-Investigator: Luigina Mollica, MD | |
McGill University Health Centre | Recruiting |
Montréal, Quebec, Canada, H4A 3J1 | |
Contact: Daniel Waller 514-934-1934 ext 36897 daniel.waller@mcgill.ca | |
Principal Investigator: Michael Sebag, MD | |
Sub-Investigator: Chaim Shustik, MD | |
Sub-Investigator: Rayan Kaedbey, MD | |
Sub-Investigator: John Storring, MD |
Principal Investigator: | Anthony J Reiman, MD | Horizon Health Network |
Documents provided by Dr. Anthony Reiman, Horizon Health Network:
Responsible Party: | Dr. Anthony Reiman, Principal Investigator, Horizon Health Network |
ClinicalTrials.gov Identifier: | NCT03421132 |
Other Study ID Numbers: |
M4 |
First Posted: | February 5, 2018 Key Record Dates |
Last Update Posted: | February 11, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |