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Multiple Myeloma Molecular Monitoring Study (M4)

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ClinicalTrials.gov Identifier: NCT03421132
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Anthony Reiman, Horizon Health Network

Study Description
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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
Multiple Myeloma

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
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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 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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)

  9. Correlative Study: Circulating Tumor DNA [ Time Frame: 5 years ]
    The investigators will also investigate prognostic significance of circulating tumour (ct) DNA profiles

  10. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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
Study Population
Patients will be recruited through hospital oncology clinics across Canada
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Nicole Barry, MA 506-648-6902 nicole.barry@horizonnb.ca

Locations
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         
Sponsors and Collaborators
Horizon Health Network
Investigators
Principal Investigator: Anthony J Reiman, MD Horizon Health Network
  Study Documents (Full-Text)

Documents provided by Dr. Anthony Reiman, Horizon Health Network:
Study Protocol and Statistical Analysis Plan  [PDF] April 26, 2017

More Information
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Publications:
Avet-Loiseau H, Corre J, Lauwers-Cances V, Chretien M, Robillard N, Leleu X, et al. 191 Evaluation of Minimal Residual Disease (MRD) By Next Generation Sequencing (NGS) Is Highly Predictive of Progression Free Survival in the IFM/DFCI 2009 Study. Blood 126(23): 191, 2015.

Responsible Party: Dr. Anthony Reiman, Principal Investigator, Horizon Health Network
ClinicalTrials.gov Identifier: NCT03421132     History of Changes
Other Study ID Numbers: M4
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
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

Additional relevant MeSH terms:
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