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Trial record 1 of 1 for:    NCT03807128
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MYeloma Resistance And Clonal Evolution (MYRACLE)

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ClinicalTrials.gov Identifier: NCT03807128
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. Because MM is classified as an incurable disease, therapeutic resistance is of great interest. However, knowledge about the biological mechanisms underlying resistance associated with MM therapies and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective cohort of patients with MM, is set up to address this limitation.

Condition or disease Intervention/treatment
Multiple Myeloma Other: No interventional study

Detailed Description:
The MYRACLE cohort study aims at including all patients (>18 years old) who are diagnosed with MM in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in Northwestern France. Any such patient providing a signed informed consent is included. All subjects are followed up until refusal to participate in the study, emigration or death. The MYRACLE follow-up is continuous and collects data on socio-economic status, medical status, MM therapies and associated events (resistance, side effects). Participants also complete standardized quality of life (QOL) questionnaires. In addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. If diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: MYeloma Resistance And Clonal Evolution
Actual Study Start Date : February 11, 2019
Estimated Primary Completion Date : October 1, 2028
Estimated Study Completion Date : October 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


Intervention Details:
  • Other: No interventional study
    No interventional study


Primary Outcome Measures :
  1. Describe the mechanisms of resistance of myeloma cells. [ Time Frame: Ten years ]
    Number of resistance.


Biospecimen Retention:   Samples With DNA
blood, urine, bone marrow


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population corresponds to multiple myeloma patients managed in the hematology departments of the University Hospital of Nantes and the CHD of La Roche sur Yon.

Recruitment of the hematology departments of the University Hospital of Nantes and CHD of La Roche sur Yon makes it possible to envisage an annual recruitment of 60 new myeloma diagnoses, and an annual number of 80 relapses. These data are estimated from the number of files submitted to the Multidisciplinary Collaborative Meeting (RPN) and the annual inclusion number in clinical trials. This number represents a cohort of about 140 inclusions per year. The average number of visits can be estimated at 1.5 / year per patient.

Criteria

Inclusion Criteria:

  • Patient with diagnosis of multiple myeloma according to standard criteria
  • Age >18

Exclusion Criteria:

  • Minor patient
  • Patient under guardianship
  • Protected patient

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): NCT03807128


Contacts
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Contact: Cyrille TOUZEAU, PU 02 40 08 32 71 cyrille.touzeau@chu-nantes.fr

Locations
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France
La Roche sur Yon Hospital Departmental Recruiting
La Roche-sur-Yon, France, 85000
Contact: Hervé MAISONNEUVE, PU    02 51 44 61 73    herve.maisonneuve@chd-vendee.fr   
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Cyrille TOUZEAU, PU    02 53 48 24 05    cyrille.touzeau@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Cyrille TOUZEAU, PU CHU Nantes

Additional Information:

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03807128     History of Changes
Other Study ID Numbers: RC18_0197
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Myeloma
Cohort
Resistance
Quality of life
Additional relevant MeSH terms:
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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