<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/NCT02997813</url>
  </required_header>
  <id_info>
    <org_study_id>IFM2014-05</org_study_id>
    <nct_id>NCT02997813</nct_id>
  </id_info>
  <brief_title>Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies</brief_title>
  <acronym>MOZOBIL</acronym>
  <official_title>Assessment of Mobilization Cost for Multiple Myeloma Using 2 Different Mobilization Strategies: High-dose Cyclophosphamide Versus Plerixafor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intergroupe Francophone du Myelome</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intergroupe Francophone du Myelome</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective observational cohort database analysis. The study will review&#xD;
      retrospectively the records of patients undergoing a first peripheral blood stem cell&#xD;
      mobilization for multiple myeloma in the databases from approximately 15 hospitals which are&#xD;
      part of the IFM collaborative group. Patient records will be divided into two groups of 50&#xD;
      patients minimum, maximum 100 patients or up to the number of patient records that could be&#xD;
      extracted. The first group of patients will have received plerixafor plus G-CSF without the&#xD;
      administration of chemotherapy as a mobilization strategy and a second group of patients will&#xD;
      have received cyclophosphamide plus G-CSF as a mobilization strategy.&#xD;
&#xD;
      All consecutive patients with complete set of data (and who underwent apheresis) treated&#xD;
      between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete&#xD;
      data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and&#xD;
      cyclophosphamide will be included.&#xD;
&#xD;
      All data that will be analyzed will be extracted from the selected IFM institutions which are&#xD;
      located in France.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total cost of stem cell mobilization procedure (including remobilisation if applicable)</measure>
    <time_frame>2009-2013</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of visits for administration of mobilizing agents</measure>
    <time_frame>2009-2013</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration (days) of administration of mobilizing agents</measure>
    <time_frame>2009-2013</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Agents used as mobilizing agents</measure>
    <time_frame>2009-2013</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal &gt;4.106cells/kg)</measure>
    <time_frame>2009-2013</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal &gt;4.106cells/kg)</measure>
    <time_frame>2009-2013</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">112</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Blood Stem Cell Transplant Failure</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The first group of patients will have received plerixafor plus G-CSF without the&#xD;
        administration of chemotherapy as a mobilization strategy and a second group of patients&#xD;
        will have received cyclophosphamide plus G-CSF as a mobilization strategy.&#xD;
&#xD;
        All consecutive patients with complete set of data (and who underwent apheresis) treated&#xD;
        between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete&#xD;
        data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and&#xD;
        cyclophosphamide will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hematology patients diagnosed with Multiple Myeloma who are candidates for autologous&#xD;
             hematopoietic stem cell transplantation (ASCT) upfront.&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Undergone prior successful peripheral blood stem cell mobilization with&#xD;
             Cyclophosphamid or Plerixafor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years;&#xD;
&#xD;
          -  Primary diagnosis other than Multiple Myeloma&#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>Xavier Leleu, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Service des maladies du sang, Hôpital Huriez, CHRU, Lille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Denis Caillot, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Service d'Hématologie Clinique, Hôpital Le Bocage, CHU Dijon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eric Deconinck, Pr</last_name>
    <role>Study Director</role>
    <affiliation>Hématologie, Hôpital Jean Minjoz, CHU Besançon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samuel Limat, Pr</last_name>
    <role>Study Director</role>
    <affiliation>Pharmacie centrale, Hôpital Jean Minjoz, CHU Besançon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire (CHU) de Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Lyon</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie Centre de Lutte Contre le Cancer (CLCC)</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Pitié Salpetriêre</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Debré Hématologie</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>No</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/NCT02997813
org study id: IFM2014-05
nct id: NCT02997813
lead sponsor: 
has dmc: No
This is a retrospective observational cohort database analysis. The study will review
      retrospectively the records of patients undergoing a first peripheral blood stem cell
      mobilization for multiple myeloma in the databases from approximately 15 hospitals which are
      part of the IFM collaborative group. Patient records will be divided into two groups of 50
      patients minimum, maximum 100 patients or up to the number of patient records that could be
      extracted. The first group of patients will have received plerixafor plus G-CSF without the
      administration of chemotherapy as a mobilization strategy and a second group of patients will
      have received cyclophosphamide plus G-CSF as a mobilization strategy.

      All consecutive patients with complete set of data (and who underwent apheresis) treated
      between 2009 and 2013 with G-CSF and plerixafor and all consecutive patients with complete
      data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and
      cyclophosphamide will be included.

      All data that will be analyzed will be extracted from the selected IFM institutions which are
      located in France.
observational model: Cohort
time perspective: Retrospective
measure: Total cost of stem cell mobilization procedure (including remobilisation if applicable)
time frame: 2009-2013
measure: Number of visits for administration of mobilizing agents
time frame: 2009-2013
measure: Duration (days) of administration of mobilizing agents
time frame: 2009-2013
measure: Agents used as mobilizing agents
time frame: 2009-2013
measure: Attainment of CD34+ target (yes, no) (min 2.106 cells/kg, ideal >4.106cells/kg)
time frame: 2009-2013
measure: Number of days needed to meet CD34+ target level (min 2.106 cells/kg, ideal >4.106cells/kg)
time frame: 2009-2013
arm group label: Cohort 1
description: All consecutive patients with complete set of data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and plerixafor
arm group label: Cohort 2
description: All consecutive patients with complete data (and who underwent apheresis) treated between 2009 and 2013 with G-CSF and cyclophosphamide
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Xavier Leleu, Dr
role: Study Chair
affiliation: Service des maladies du sang, Hôpital Huriez, CHRU, Lille
last name: Denis Caillot, Dr
role: Study Director
affiliation: Service d'Hématologie Clinique, Hôpital Le Bocage, CHU Dijon
last name: Eric Deconinck, Pr
role: Study Director
affiliation: Hématologie, Hôpital Jean Minjoz, CHU Besançon
last name: Samuel Limat, Pr
role: Study Director
affiliation: Pharmacie centrale, Hôpital Jean Minjoz, CHU Besançon
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No