<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03807128</url>
  </required_header>
  <id_info>
    <org_study_id>RC18_0197</org_study_id>
    <nct_id>NCT03807128</nct_id>
  </id_info>
  <brief_title>MYeloma Resistance And Clonal Evolution</brief_title>
  <acronym>MYRACLE</acronym>
  <official_title>MYeloma Resistance And Clonal Evolution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple Myeloma (MM) is often associated with progression, temporary response to therapy and&#xD;
      a high relapse rate over time resulting in a poor long-term prognosis. Because MM is&#xD;
      classified as an incurable disease, therapeutic resistance is of great interest. However,&#xD;
      knowledge about the biological mechanisms underlying resistance associated with MM therapies&#xD;
      and about associated predictors remains poor. The MYRACLE cohort, a multicenter prospective&#xD;
      cohort of patients with MM, is set up to address this limitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The MYRACLE cohort study aims at including all patients (&gt;18 years old) who are diagnosed&#xD;
      with MM in any stage of the disease and treated in specialized oncology centers in 2 public&#xD;
      hospitals in Northwestern France. Any such patient providing a signed informed consent is&#xD;
      included. All subjects are followed up until refusal to participate in the study, emigration&#xD;
      or death. The MYRACLE follow-up is continuous and collects data on socio-economic status,&#xD;
      medical status, MM therapies and associated events (resistance, side effects). Participants&#xD;
      also complete standardized quality of life (QOL) questionnaires. In addition, participants&#xD;
      are asked to donate blood samples that will support ex vivo analysis of expression and&#xD;
      functional assays required to uncover predictive biomarkers and companion diagnostics. If&#xD;
      diagnostic biopsies are performed during the course of the disease, extracted biological&#xD;
      samples are kept in a dedicated biobank.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 11, 2019</start_date>
  <completion_date type="Anticipated">February 11, 2029</completion_date>
  <primary_completion_date type="Anticipated">February 11, 2029</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Describe the mechanisms of resistance of myeloma cells.</measure>
    <time_frame>Ten years</time_frame>
    <description>Number of resistance.</description>
  </primary_outcome>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Multiple Myeloma</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No interventional study</intervention_name>
    <description>No interventional study</description>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood, urine, bone marrow&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population corresponds to multiple myeloma patients managed in the hematology&#xD;
        departments of the University Hospital of Nantes and the CHD of La Roche sur Yon.&#xD;
&#xD;
        Recruitment of the hematology departments of the University Hospital of Nantes and CHD of&#xD;
        La Roche sur Yon makes it possible to envisage an annual recruitment of 60 new myeloma&#xD;
        diagnoses, and an annual number of 80 relapses. These data are estimated from the number of&#xD;
        files submitted to the Multidisciplinary Collaborative Meeting (RPN) and the annual&#xD;
        inclusion number in clinical trials. This number represents a cohort of about 140&#xD;
        inclusions per year. The average number of visits can be estimated at 1.5 / year per&#xD;
        patient.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with diagnosis of multiple myeloma according to standard criteria&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patient&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Protected patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cyrille TOUZEAU, PU</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cyrille TOUZEAU, PU</last_name>
    <phone>02 40 08 32 71</phone>
    <email>cyrille.touzeau@chu-nantes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>La Roche sur Yon Hospital Departmental</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cyrille TOUZEAU, PU</last_name>
      <phone>02 53 48 24 05</phone>
      <email>cyrille.touzeau@chu-nantes.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myeloma</keyword>
  <keyword>Cohort</keyword>
  <keyword>Resistance</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03807128
org study id: RC18_0197
nct id: NCT03807128
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Describe the mechanisms of resistance of myeloma cells.
time frame: Ten years
description: Number of resistance.
intervention type: Other
intervention name: No interventional study
description: No interventional study
blood, urine, bone marrow
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cyrille TOUZEAU, PU
role: Principal Investigator
affiliation: CHU Nantes
last name: Cyrille TOUZEAU, PU
phone: 02 40 08 32 71
email: cyrille.touzeau@chu-nantes.fr
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: Undecided