<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/NCT01671826</url>
  </required_header>
  <id_info>
    <org_study_id>LGT-2012</org_study_id>
    <nct_id>NCT01671826</nct_id>
  </id_info>
  <brief_title>Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years</brief_title>
  <acronym>LATMM</acronym>
  <official_title>Prospective, Observational, Multicenter Trial Evaluating Autologous Stem Cell Transplantation for Myeloma Patients Over the Age of 65</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autologous stem cell transplantation remains the gold standard of treatment for newly&#xD;
      diagnosed patients under the age of 65. Even though it is also regularly performed above the&#xD;
      age of 65, there are very few data in this patient population. The investigators will capture&#xD;
      safety and efficacy data in that setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Newly diagnosed myeloma patients above the age of 65 years will be treated the following way:&#xD;
      Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade&#xD;
      Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the&#xD;
      induction phase, for patients at least in partial remission, a collection of peripheral blood&#xD;
      stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2)&#xD;
      followed by PBSC autologous transplantation is then performed. Three months post transplant,&#xD;
      2-3 cycles (similar to the initial induction phase) of consolidation are allowed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>after induction, 3 months post transplant, 2 months post consolidation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time To Progression</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Newly Diagnosed Myeloma Patient Above 65 Years Old</condition>
  <arm_group>
    <arm_group_label>above 65 years old</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed myeloma patients over 65 years of age and a measurable disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed MM,&#xD;
&#xD;
          -  age over 65,&#xD;
&#xD;
          -  measurable disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 65 and/or not proceeding to autologous PBSC transplantation&#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>Laurent Garderet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmette</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>June 23, 2016</last_update_submitted>
  <last_update_submitted_qc>June 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Autologous Stem Cell Transplantation</keyword>
  <keyword>Elderly Patients</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>
  <!-- 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/NCT01671826
org study id: LGT-2012
nct id: NCT01671826
lead sponsor: 
has dmc: No
Autologous stem cell transplantation remains the gold standard of treatment for newly
      diagnosed patients under the age of 65. Even though it is also regularly performed above the
      age of 65, there are very few data in this patient population. The investigators will capture
      safety and efficacy data in that setting.
Newly diagnosed myeloma patients above the age of 65 years will be treated the following way:
      Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade
      Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the
      induction phase, for patients at least in partial remission, a collection of peripheral blood
      stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2)
      followed by PBSC autologous transplantation is then performed. Three months post transplant,
      2-3 cycles (similar to the initial induction phase) of consolidation are allowed.
observational model: Cohort
time perspective: Prospective
measure: Progression Free survival
time frame: 2 years
measure: Response
time frame: after induction, 3 months post transplant, 2 months post consolidation
measure: Time To Progression
time frame: 2 years
measure: Overall Survival
time frame: 2 years
arm group label: above 65 years old
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent Garderet, MD
role: Principal Investigator
affiliation: Assistance Publique
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell