<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/NCT02248402</url>
  </required_header>
  <id_info>
    <org_study_id>13-038</org_study_id>
    <nct_id>NCT02248402</nct_id>
  </id_info>
  <brief_title>Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma</brief_title>
  <acronym>Vax-DC/MM</acronym>
  <official_title>A Phase 1/2a Study to Evaluate Safety and Efficacy of Autologous Dendritic Cell Therapy in Patients With Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonnam National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonnam National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using&#xD;
      dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma.&#xD;
      Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded with the&#xD;
      ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to&#xD;
      examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory multiple&#xD;
      myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  To create the Vax-DC/MM, myeloma cells will be obtained from the bone marrow of the&#xD;
           participants, and leukapheresis will be performed to obtain dendritic cells&#xD;
&#xD;
        -  Not everyone who participants in this study will be receiving the same dose of study&#xD;
           vaccine. A small group of patients will be enrolled into the study and given a certain&#xD;
           dose. If they tolerate it, the next group of patients enrolled will received a higher&#xD;
           dose.&#xD;
&#xD;
        -  Before the first injection of Vax-DC, low dose cyclophosphamide will be administered to&#xD;
           stimulate immune response.&#xD;
&#xD;
        -  Participants will be received a certain dose of Vax-DC weekly four times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <primary_completion_date type="Anticipated">October 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>1 years</time_frame>
    <description>Adverse events were assessed using the National Cancer Institute common toxicity criteria (NCI-CTC) for adverse events version 4.0 every injection of Vax-DC/MM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response after completion of Vax-DC/MM injection</measure>
    <time_frame>2 year</time_frame>
    <description>The International Myeloma Working Group uniform criteria were used to assess the clinical response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>2 year</time_frame>
    <description>Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Vax-DC/MM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vax-DC/MM</intervention_name>
    <arm_group_label>Vax-DC/MM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsed or refractory multiple myeloma who received at least one prior therapy&#xD;
             including thalidomide, bortezomib, or lenalidomide-containing regimen&#xD;
&#xD;
          -  Subjects with measurable disease defined as at least one of the following Serum&#xD;
             M-protein ≥ 1.0 g/dL Urine M-protein ≥ 400 mg/24hr&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group Performance Status ≤ 2&#xD;
&#xD;
          -  Hemoglobin ≥ 8 g/dL (≥ 4.96 mol/L): Prior red blood cell transfusion or recombinant&#xD;
             human erythropoietin use is allowed.&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1.0 x 109/L&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) &lt; 3 times the upper limit of normal&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) &lt; 3 times the upper limit of normal&#xD;
&#xD;
          -  Subjects (or their legally acceptable representatives) must have signed an informed&#xD;
             consent document indicating that they understand the purpose of and procedures&#xD;
             required for the study and are willing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoldering or indolent myeloma&#xD;
&#xD;
          -  Uncontrolled or severe cardiovascular disease (cardiac ejection fraction&lt;0.5, Severe&#xD;
             conduction disorder )&#xD;
&#xD;
          -  Sepsis or current active infection&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Received other immunotherapy treatment&#xD;
&#xD;
          -  Clinically significant autoimmune disease&#xD;
&#xD;
          -  Serious medical or psychiatric illness likely to interfere with participation in this&#xD;
             clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sung-Hoon Jung, M.D</last_name>
    <phone>+82 61 379 7622</phone>
    <email>shglory@hanmail.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <state>Jeollanamdo</state>
        <zip>519-763</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sung-Hoon Jung, M.D</last_name>
      <phone>+82 61 379 7622</phone>
      <email>shglory@hanmail.net</email>
    </contact>
    <investigator>
      <last_name>Sung-Hoon Jung, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonnam National University Hospital</investigator_affiliation>
    <investigator_full_name>Sung-Hoon Jung</investigator_full_name>
    <investigator_title>M.D</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>
  <!-- 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/NCT02248402
org study id: 13-038
nct id: NCT02248402
lead sponsor: 
has dmc: Yes
Multiple myeloma remains incurable disease in most patients . Cellular immunotherapy using
      dendritic cells is emerging as a useful immunotherapeutic modality to treat multiple myeloma.
      Vax-DC/MM is an potent immunotherapeutic agent generated by dendritic cells loaded with the
      ultraviolet B-irradiated autologous human myeloma cells. The main purpose of this study is to
      examine the safety and efficacy of Vax-DC/MM in patients with relapsed or refractory multiple
      myeloma.
-  To create the Vax-DC/MM, myeloma cells will be obtained from the bone marrow of the
           participants, and leukapheresis will be performed to obtain dendritic cells

        -  Not everyone who participants in this study will be receiving the same dose of study
           vaccine. A small group of patients will be enrolled into the study and given a certain
           dose. If they tolerate it, the next group of patients enrolled will received a higher
           dose.

        -  Before the first injection of Vax-DC, low dose cyclophosphamide will be administered to
           stimulate immune response.

        -  Participants will be received a certain dose of Vax-DC weekly four times.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with adverse events
time frame: 1 years
description: Adverse events were assessed using the National Cancer Institute common toxicity criteria (NCI-CTC) for adverse events version 4.0 every injection of Vax-DC/MM
measure: Clinical response after completion of Vax-DC/MM injection
time frame: 2 year
description: The International Myeloma Working Group uniform criteria were used to assess the clinical response.
measure: Progression free survival
time frame: 2 year
description: Progression free survival was defined as the period from the start of treatment until the end follow-up or death from any cause.
arm group label: Vax-DC/MM
arm group type: Experimental
intervention type: Biological
intervention name: Vax-DC/MM
arm group label: Vax-DC/MM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sung-Hoon Jung, M.D
phone: +82 61 379 7622
email: shglory@hanmail.net
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonnam National University Hospital
investigator full name: Sung-Hoon Jung
investigator title: M.D
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell