<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/NCT02184897</url>
  </required_header>
  <id_info>
    <org_study_id>AMC_MM01</org_study_id>
    <nct_id>NCT02184897</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization</brief_title>
  <official_title>Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Twenty four patients with multiple myeloma will be randomized to either AM group&#xD;
      (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ).&#xD;
      Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4&#xD;
      in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with&#xD;
      pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic&#xD;
      progenitor cell count. In addition, the yield of stem cell collection between two arms will&#xD;
      be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pharmacokinetic data of lenograstim</measure>
    <time_frame>on day 1 of apheresis</time_frame>
    <description>AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pharmacodynamic data: CD34+ cell count by flow cytometry</measure>
    <time_frame>on day 1 of apheresis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pharmacodynamic data: absolute neutrophil count</measure>
    <time_frame>on day 1 of apheresis</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pharmacodynamic data: hematopoietic progenitor cells (HPC)</measure>
    <time_frame>on day 1 of apheresis</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>AM group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lenograstim 10 microgram/kg/day</intervention_name>
    <arm_group_label>AM group</arm_group_label>
    <arm_group_label>PM group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: above 17 years, below 65 years old&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  ECOG 0-1&#xD;
&#xD;
          -  autologous stem cell transplant candidate among patients with multiple myeloma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior history of hematopoetic stem cell transplantation&#xD;
&#xD;
          -  history of failure to mobilize hematopoietic stem cells&#xD;
&#xD;
          -  history of G-CSF administration within 2 weeks before enrollment to this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Asan Medical Center, University of Ulsan College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>1387-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>June 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 23, 2016</last_update_submitted>
  <last_update_submitted_qc>July 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Cheolwon Suh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_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/NCT02184897
org study id: AMC_MM01
nct id: NCT02184897
lead sponsor: 
has dmc: No
Twenty four patients with multiple myeloma will be randomized to either AM group
      (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ).
      Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4
      in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with
      pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic
      progenitor cell count. In addition, the yield of stem cell collection between two arms will
      be analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: pharmacokinetic data of lenograstim
time frame: on day 1 of apheresis
description: AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
measure: pharmacodynamic data: CD34+ cell count by flow cytometry
time frame: on day 1 of apheresis
measure: pharmacodynamic data: absolute neutrophil count
time frame: on day 1 of apheresis
measure: pharmacodynamic data: hematopoietic progenitor cells (HPC)
time frame: on day 1 of apheresis
arm group label: AM group
arm group type: Active Comparator
description: Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
arm group label: PM group
arm group type: Experimental
description: Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5
intervention type: Drug
intervention name: lenograstim 10 microgram/kg/day
arm group label: AM group
arm group label: PM group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Cheolwon Suh
investigator title: Professor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Lenograstim