Multiple MyelomaM4NCT03421132
Multiple Myeloma Molecular Monitoring Study
An observational study of Multiple Myeloma, run by Horizon Health Network at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 99 years
- Conditions the study is for
- Multiple Myeloma
- How many people
- 96 participants
- Where
- 9 sitesCanada
- Study dates
- 20 Feb 2018to 31 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited through hospital oncology clinics across Canada
Who may be able to join
- 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)
Who cannot join
- Ineligible for ASCT
- Does not consent to participate in MCRN database project
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Buland Mangukia
Hamilton, Ontario, L8V 1C3
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Saint John Regional Hospital (Horizon Health Network)
Saint John, New Brunswick, E2L 4L5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1X6
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: The Terry Fox Pan-Canadian Multiple Myeloma Molecular Monitoring Study
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Minimal Residual Disease (MRD) Assays
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.
Measured: 100 days post-treatment
Sensitivity of Minimal Residual Disease (MRD) Assays
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.
Measured: 12 months post-maintenance therapy
Secondary outcomes (10)
Comparison of Sensitivity of MRD Assays with PET scans
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.
Measured: 12 months post-maintenance therapy
Predicting Progression-Free Survival Using MRD Assessment
Establish the prognostic significance of MRD assessment (i.e., the two MRD assays, and PET scans) on progression-free survival
Measured: 5 years
Predicting Overall Survival Using MRD Assessment
Establish the prognostic significance of MRD assessment (i.e., the two MRD assays, and PET scans) on overall survival
Measured: 5 years
Quality-Adjusted Life Years (QALYs) Gained
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.
Measured: 5 years
Incremental Cost-Effectiveness of MRD Testing
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.
Measured: 5 years
Productivity Costs Associated with MRD Testing
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.
Measured: 5 years
Multiple Myeloma Patients' Quality of Life (QOL)
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.
Measured: 5 years
Correlative Study: Sensitivity and Specificity of Drug Resistance Assays
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)
Measured: 5 years
Correlative Study: Circulating Tumor DNA
The investigators will also investigate prognostic significance of circulating tumour (ct) DNA profiles
Measured: 5 years
Correlative Study: Describing Myeloma Progenitor Populations
The investigators will also seek to understand how the cancer recurs and regrows, even for those who achieve an MRD state.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start20 Feb 2018
- Primary completion31 Dec 2024
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anthony Reiman, Horizon Health Network
- Investigators
- Anthony J Reiman, MD, Principal investigator, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421132
- Sponsor's protocol ID
- M4
- Acronym
- M4
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2018
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
PubMed 25184863Bolli N, Avet-Loiseau H, Wedge DC, Van Loo P, Alexandrov LB, Martincorena I, Dawson KJ, Iorio F, Nik-Zainal S, Bignell GR, Hinton JW, Li Y, Tubio JM, McLaren S, O' Meara S, Butler AP, Teague JW, Mudie L, Anderson E, Rashid N, Tai YT, Shammas MA, Sperling AS, Fulciniti M, Richardson PG, Parmigiani G, Magrangeas F, Minvielle S, Moreau P, Attal M, Facon T, Futreal PA, Anderson KC, Campbell PJ, Munshi NC. Heterogeneity of genomic evolution and mutational profiles in multiple myeloma. Nat Commun. 2014;5:2997. doi: 10.1038/ncomms3997.
PubMed 24429703Chapman MA, Lawrence MS, Keats JJ, Cibulskis K, Sougnez C, Schinzel AC, Harview CL, Brunet JP, Ahmann GJ, Adli M, Anderson KC, Ardlie KG, Auclair D, Baker A, Bergsagel PL, Bernstein BE, Drier Y, Fonseca R, Gabriel SB, Hofmeister CC, Jagannath S, Jakubowiak AJ, Krishnan A, Levy J, Liefeld T, Lonial S, Mahan S, Mfuko B, Monti S, Perkins LM, Onofrio R, Pugh TJ, Rajkumar SV, Ramos AH, Siegel DS, Sivachenko A, Stewart AK, Trudel S, Vij R, Voet D, Winckler W, Zimmerman T, Carpten J, Trent J, Hahn WC, Garraway LA, Meyerson M, Lander ES, Getz G, Golub TR. Initial genome sequencing and analysis of multiple myeloma. Nature. 2011 Mar 24;471(7339):467-72. doi: 10.1038/nature09837.
PubMed 21430775Chng WJ, Dispenzieri A, Chim CS, Fonseca R, Goldschmidt H, Lentzsch S, Munshi N, Palumbo A, Miguel JS, Sonneveld P, Cavo M, Usmani S, Durie BG, Avet-Loiseau H; International Myeloma Working Group. IMWG consensus on risk stratification in multiple myeloma. Leukemia. 2014 Feb;28(2):269-77. doi: 10.1038/leu.2013.247. Epub 2013 Aug 26.
PubMed 23974982Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
PubMed 15317891Gonzalez D, van der Burg M, Garcia-Sanz R, Fenton JA, Langerak AW, Gonzalez M, van Dongen JJ, San Miguel JF, Morgan GJ. Immunoglobulin gene rearrangements and the pathogenesis of multiple myeloma. Blood. 2007 Nov 1;110(9):3112-21. doi: 10.1182/blood-2007-02-069625. Epub 2007 Jul 18.
PubMed 17634408Kapoor P, Kumar SK, Dispenzieri A, Lacy MQ, Buadi F, Dingli D, Russell SJ, Hayman SR, Witzig TE, Lust JA, Leung N, Lin Y, Zeldenrust SR, McCurdy A, Greipp PR, Kyle RA, Rajkumar SV, Gertz MA. Importance of achieving stringent complete response after autologous stem-cell transplantation in multiple myeloma. J Clin Oncol. 2013 Dec 20;31(36):4529-35. doi: 10.1200/JCO.2013.49.0086. Epub 2013 Nov 18.
PubMed 24248686Korde N, Roschewski M, Zingone A, Kwok M, Manasanch EE, Bhutani M, Tageja N, Kazandjian D, Mailankody S, Wu P, Morrison C, Costello R, Zhang Y, Burton D, Mulquin M, Zuchlinski D, Lamping L, Carpenter A, Wall Y, Carter G, Cunningham SC, Gounden V, Sissung TM, Peer C, Maric I, Calvo KR, Braylan R, Yuan C, Stetler-Stevenson M, Arthur DC, Kong KA, Weng L, Faham M, Lindenberg L, Kurdziel K, Choyke P, Steinberg SM, Figg W, Landgren O. Treatment With Carfilzomib-Lenalidomide-Dexamethasone With Lenalidomide Extension in Patients With Smoldering or Newly Diagnosed Multiple Myeloma. JAMA Oncol. 2015 Sep;1(6):746-54. doi: 10.1001/jamaoncol.2015.2010.
PubMed 26181891Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
PubMed 27511158Leung-Hagesteijn C, Erdmann N, Cheung G, Keats JJ, Stewart AK, Reece DE, Chung KC, Tiedemann RE. Xbp1s-Negative Tumor B Cells and Pre-Plasmablasts Mediate Therapeutic Proteasome Inhibitor Resistance in Multiple Myeloma. Cancer Cell. 2015 Oct 12;28(4):541-542. doi: 10.1016/j.ccell.2015.09.010. Epub 2015 Oct 12. No abstract available.
PubMed 28854350Mailankody S, Korde N, Lesokhin AM, Lendvai N, Hassoun H, Stetler-Stevenson M, Landgren O. Minimal residual disease in multiple myeloma: bringing the bench to the bedside. Nat Rev Clin Oncol. 2015 May;12(5):286-95. doi: 10.1038/nrclinonc.2014.239. Epub 2015 Jan 27.
PubMed 25622976Martinez-Lopez J, Lahuerta JJ, Pepin F, Gonzalez M, Barrio S, Ayala R, Puig N, Montalban MA, Paiva B, Weng L, Jimenez C, Sopena M, Moorhead M, Cedena T, Rapado I, Mateos MV, Rosinol L, Oriol A, Blanchard MJ, Martinez R, Blade J, San Miguel J, Faham M, Garcia-Sanz R. Prognostic value of deep sequencing method for minimal residual disease detection in multiple myeloma. Blood. 2014 May 15;123(20):3073-9. doi: 10.1182/blood-2014-01-550020. Epub 2014 Mar 19.
PubMed 24646471Matsui W, Wang Q, Barber JP, Brennan S, Smith BD, Borrello I, McNiece I, Lin L, Ambinder RF, Peacock C, Watkins DN, Huff CA, Jones RJ. Clonogenic multiple myeloma progenitors, stem cell properties, and drug resistance. Cancer Res. 2008 Jan 1;68(1):190-7. doi: 10.1158/0008-5472.CAN-07-3096.
PubMed 18172311Moreau P, Attal M, Caillot D, Macro M, Karlin L, Garderet L, Facon T, Benboubker L, Escoffre-Barbe M, Stoppa AM, Laribi K, Hulin C, Perrot A, Marit G, Eveillard JR, Caillon F, Bodet-Milin C, Pegourie B, Dorvaux V, Chaleteix C, Anderson K, Richardson P, Munshi NC, Avet-Loiseau H, Gaultier A, Nguyen JM, Dupas B, Frampas E, Kraeber-Bodere F. Prospective Evaluation of Magnetic Resonance Imaging and [18F]Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography at Diagnosis and Before Maintenance Therapy in Symptomatic Patients With Multiple Myeloma Included in the IFM/DFCI 2009 Trial: Results of the IMAJEM Study. J Clin Oncol. 2017 Sep 1;35(25):2911-2918. doi: 10.1200/JCO.2017.72.2975. Epub 2017 Jul 7.
PubMed 28686535
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Terry Fox Pan-Canadian Multiple Myeloma Molecular Monitoring Study
- ClinicalTrials.gov ID
- NCT03421132
- Acronym / sponsor ID
- M4 / M4
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited through hospital oncology clinics across Canada
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Ineligible for ASCT
- Does not consent to participate in MCRN database project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Comparison of Sensitivity of MRD Assays with PET scans
Time frame: 12 months post-maintenance therapy
Predicting Progression-Free Survival Using MRD Assessment
Time frame: 5 years
Predicting Overall Survival Using MRD Assessment
Time frame: 5 years
Quality-Adjusted Life Years (QALYs) Gained
Time frame: 5 years
Incremental Cost-Effectiveness of MRD Testing
Time frame: 5 years
Productivity Costs Associated with MRD Testing
Time frame: 5 years
Multiple Myeloma Patients' Quality of Life (QOL)
Time frame: 5 years
Correlative Study: Sensitivity and Specificity of Drug Resistance Assays
Time frame: 5 years
Correlative Study: Circulating Tumor DNA
Time frame: 5 years
Correlative Study: Describing Myeloma Progenitor Populations
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- BackgroundAvet-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.
- Background: PubMed 25184863Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
- Background: PubMed 24429703Bolli N, Avet-Loiseau H, Wedge DC, Van Loo P, Alexandrov LB, Martincorena I, Dawson KJ, Iorio F, Nik-Zainal S, Bignell GR, Hinton JW, Li Y, Tubio JM, McLaren S, O' Meara S, Butler AP, Teague JW, Mudie L, Anderson E, Rashid N, Tai YT, Shammas MA, Sperling AS, Fulciniti M, Richardson PG, Parmigiani G, Magrangeas F, Minvielle S, Moreau P, Attal M, Facon T, Futreal PA, Anderson KC, Campbell PJ, Munshi NC. Heterogeneity of genomic evolution and mutational profiles in multiple myeloma. Nat Commun. 2014;5:2997. doi: 10.1038/ncomms3997.
- Background: PubMed 21430775Chapman MA, Lawrence MS, Keats JJ, Cibulskis K, Sougnez C, Schinzel AC, Harview CL, Brunet JP, Ahmann GJ, Adli M, Anderson KC, Ardlie KG, Auclair D, Baker A, Bergsagel PL, Bernstein BE, Drier Y, Fonseca R, Gabriel SB, Hofmeister CC, Jagannath S, Jakubowiak AJ, Krishnan A, Levy J, Liefeld T, Lonial S, Mahan S, Mfuko B, Monti S, Perkins LM, Onofrio R, Pugh TJ, Rajkumar SV, Ramos AH, Siegel DS, Sivachenko A, Stewart AK, Trudel S, Vij R, Voet D, Winckler W, Zimmerman T, Carpten J, Trent J, Hahn WC, Garraway LA, Meyerson M, Lander ES, Getz G, Golub TR. Initial genome sequencing and analysis of multiple myeloma. Nature. 2011 Mar 24;471(7339):467-72. doi: 10.1038/nature09837.
- Background: PubMed 23974982Chng WJ, Dispenzieri A, Chim CS, Fonseca R, Goldschmidt H, Lentzsch S, Munshi N, Palumbo A, Miguel JS, Sonneveld P, Cavo M, Usmani S, Durie BG, Avet-Loiseau H; International Myeloma Working Group. IMWG consensus on risk stratification in multiple myeloma. Leukemia. 2014 Feb;28(2):269-77. doi: 10.1038/leu.2013.247. Epub 2013 Aug 26.
- Background: PubMed 15317891Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
- Background: PubMed 17634408Gonzalez D, van der Burg M, Garcia-Sanz R, Fenton JA, Langerak AW, Gonzalez M, van Dongen JJ, San Miguel JF, Morgan GJ. Immunoglobulin gene rearrangements and the pathogenesis of multiple myeloma. Blood. 2007 Nov 1;110(9):3112-21. doi: 10.1182/blood-2007-02-069625. Epub 2007 Jul 18.
- Background: PubMed 24248686Kapoor P, Kumar SK, Dispenzieri A, Lacy MQ, Buadi F, Dingli D, Russell SJ, Hayman SR, Witzig TE, Lust JA, Leung N, Lin Y, Zeldenrust SR, McCurdy A, Greipp PR, Kyle RA, Rajkumar SV, Gertz MA. Importance of achieving stringent complete response after autologous stem-cell transplantation in multiple myeloma. J Clin Oncol. 2013 Dec 20;31(36):4529-35. doi: 10.1200/JCO.2013.49.0086. Epub 2013 Nov 18.
- Background: PubMed 26181891Korde N, Roschewski M, Zingone A, Kwok M, Manasanch EE, Bhutani M, Tageja N, Kazandjian D, Mailankody S, Wu P, Morrison C, Costello R, Zhang Y, Burton D, Mulquin M, Zuchlinski D, Lamping L, Carpenter A, Wall Y, Carter G, Cunningham SC, Gounden V, Sissung TM, Peer C, Maric I, Calvo KR, Braylan R, Yuan C, Stetler-Stevenson M, Arthur DC, Kong KA, Weng L, Faham M, Lindenberg L, Kurdziel K, Choyke P, Steinberg SM, Figg W, Landgren O. Treatment With Carfilzomib-Lenalidomide-Dexamethasone With Lenalidomide Extension in Patients With Smoldering or Newly Diagnosed Multiple Myeloma. JAMA Oncol. 2015 Sep;1(6):746-54. doi: 10.1001/jamaoncol.2015.2010.
- Background: PubMed 27511158Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
- Background: PubMed 28854350Leung-Hagesteijn C, Erdmann N, Cheung G, Keats JJ, Stewart AK, Reece DE, Chung KC, Tiedemann RE. Xbp1s-Negative Tumor B Cells and Pre-Plasmablasts Mediate Therapeutic Proteasome Inhibitor Resistance in Multiple Myeloma. Cancer Cell. 2015 Oct 12;28(4):541-542. doi: 10.1016/j.ccell.2015.09.010. Epub 2015 Oct 12. No abstract available.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony J Reiman, MD principal investigator
Horizon Health Network
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Horizon Health Network at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Minimal Residual Disease (MRD) Assays (time frame: 100 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03421132, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.