<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/NCT02981199</url>
  </required_header>
  <id_info>
    <org_study_id>MM-MSCT-001</org_study_id>
    <nct_id>NCT02981199</nct_id>
  </id_info>
  <brief_title>Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients</brief_title>
  <official_title>A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chen Wenming</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>307 Hospital of PLA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <brief_summary>
    <textblock>
      Comparison of the efficacy and safety of microtransplantation and autologous transplantation&#xD;
      in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed.&#xD;
      To identify the role of microtransplantation in the treatment of multiple myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT,&#xD;
      were randomly divided into two arms. One arm receive microtransplantation, and the other&#xD;
      accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were&#xD;
      also been observed. Clear the above program related hematopoietic recovery, remission rate,&#xD;
      infection and recurrence rate, survival rate and the formation of micro inlay, minimal&#xD;
      residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment&#xD;
      of multiple myeloma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of complete remission</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>minimal residual disease</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hematopoietic recovery</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>infection</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GVHD</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>relapse</measure>
    <time_frame>2 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Microtransplantation</condition>
  <condition>Autologous Stem Cell Transplantation</condition>
  <condition>Multiple Myeloma in Relapse</condition>
  <arm_group>
    <arm_group_label>Micro-SCT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients treated with microtransplantation. [VMD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; melphalan 60mg/m2 d1; dexamethasone 20mg d1,2,4,5,8,9,11,12) + low dose allogeneic stem cell transplantation]×4cycles; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×1cycle; then maintenance therapy with thalidomide 100mg/d.&#xD;
microtransplantation = [VMD regimen chemotherapy+ low dose allogeneic stem cell transplantation]×4cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auto-SCT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients treated with Auto-SCT. conditioning with Mel+Vel regimen (melphalan 200mg/m2 d-2, bortezomib 1.3mg/m2 d-6,-3,+1,+4) + autogeneic stem cell transplantation; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×4cycle; then maintenance therapy with thalidomide 100mg/d.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stem cell transplantation</intervention_name>
    <description>conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion</description>
    <arm_group_label>Auto-SCT</arm_group_label>
    <arm_group_label>Micro-SCT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis MM compliance with IMWG diagnostic criteria(2014)&#xD;
&#xD;
          2. induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR&#xD;
&#xD;
          3. KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function &lt; II level (NYHA&#xD;
             standard) and ejection fraction &gt; 50% -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. KPS&lt;60&#xD;
&#xD;
          2. Allergy to bortezomib,epirubicin, or drug ingredients&#xD;
&#xD;
          3. Severe hepatitis and organ dysfunction: a serious infection has not been controlled;&#xD;
             cardiac ejection fraction &lt;50%, serum bilirubin &gt;3mg/dl, severe abnormal results of&#xD;
             liver function test (AST is greater than 3 times the upper limit), severe renal&#xD;
             injury; central nervous system disorders, uncontrolled mental illness&#xD;
&#xD;
          4. With more than 2 bortezomib associated with peripheral neuropathy or neuralgia&#xD;
             patients&#xD;
&#xD;
          5. Patients with active stage of the herpes zoster&#xD;
&#xD;
          6. Women in pregnancy or lactation&#xD;
&#xD;
          7. MM with AL or EM plasma cell tumor&#xD;
&#xD;
          8. The patient refused to accept the above treatment and signature&#xD;
&#xD;
          9. Donor does not meet the requirements: including HIV positive, active hepatitis B, bone&#xD;
             marrow disease, donor refused to provide hematopoietic stem cells and do not agree to&#xD;
             sign.&#xD;
&#xD;
         10. Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wenming Chen, doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guorong Wang, doctor</last_name>
    <phone>+861085231572</phone>
    <email>blunlake@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wenming Chen, doctor</last_name>
    <phone>+8685231581</phone>
    <email>wenming_chen@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Chaoyang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guorong Wang, doctor</last_name>
      <phone>+861085231572</phone>
      <email>blunlake@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Wenming Chen, doctor</last_name>
      <phone>+861085231581</phone>
      <email>wenming_chen@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Chen Wenming</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>microtransplantation</keyword>
  <keyword>multiple myeloma</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>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/NCT02981199
org study id: MM-MSCT-001
nct id: NCT02981199
lead sponsor: 
collaborator: 
Comparison of the efficacy and safety of microtransplantation and autologous transplantation
      in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed.
      To identify the role of microtransplantation in the treatment of multiple myeloma.
NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT,
      were randomly divided into two arms. One arm receive microtransplantation, and the other
      accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were
      also been observed. Clear the above program related hematopoietic recovery, remission rate,
      infection and recurrence rate, survival rate and the formation of micro inlay, minimal
      residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment
      of multiple myeloma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression-free survival
time frame: 2 years
measure: overall survival
time frame: 2 years
measure: rate of complete remission
time frame: 2 year
measure: minimal residual disease
time frame: 2 year
measure: hematopoietic recovery
time frame: 3 month
measure: infection
time frame: 3 month
measure: GVHD
time frame: 1 year
measure: relapse
time frame: 2 year
arm group label: Micro-SCT
arm group type: Active Comparator
description: patients treated with microtransplantation. [VMD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; melphalan 60mg/m2 d1; dexamethasone 20mg d1,2,4,5,8,9,11,12) + low dose allogeneic stem cell transplantation]×4cycles; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×1cycle; then maintenance therapy with thalidomide 100mg/d.
microtransplantation = [VMD regimen chemotherapy+ low dose allogeneic stem cell transplantation]×4cycles
arm group label: Auto-SCT
arm group type: Active Comparator
description: patients treated with Auto-SCT. conditioning with Mel+Vel regimen (melphalan 200mg/m2 d-2, bortezomib 1.3mg/m2 d-6,-3,+1,+4) + autogeneic stem cell transplantation; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×4cycle; then maintenance therapy with thalidomide 100mg/d.
intervention type: Procedure
intervention name: stem cell transplantation
description: conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion
arm group label: Auto-SCT
arm group label: Micro-SCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Wenming Chen, doctor
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: Guorong Wang, doctor
phone: +861085231572
email: blunlake@163.com
last name: Wenming Chen, doctor
phone: +8685231581
email: wenming_chen@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Chen Wenming
investigator title: professor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No