<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/NCT02971982</url>
  </required_header>
  <id_info>
    <org_study_id>myeloma-02</org_study_id>
    <nct_id>NCT02971982</nct_id>
  </id_info>
  <brief_title>PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia</brief_title>
  <official_title>Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Soochow University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients will receive RCD or PCD combination as induction treatment followed by rituximab or&#xD;
      velcade maintenance therapy, as the investigators try to compare the, very good partial&#xD;
      remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR +&#xD;
      partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the&#xD;
      research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single-centre, randomised study, looking at a series of 40 patients up&#xD;
      to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously&#xD;
      treated. Patients will receive RCD or PCD combination as induction treatment followed by&#xD;
      rituximab or velcade maintenance therapy, as the investigators try to compare the, very good&#xD;
      partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR +&#xD;
      VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the&#xD;
      research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigators try to compare the complete remission (CR) rates at the end of the research.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.</measure>
    <time_frame>2 yeas</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Treatment</condition>
  <arm_group>
    <arm_group_label>rituximab /Dex/CTX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Velcade/Dex/CTX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rituximab /Dexamethasone/cyclophosphamide</intervention_name>
    <description>rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg</description>
    <arm_group_label>rituximab /Dex/CTX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Velcade/Dexamethasone/cyclophosphamide</intervention_name>
    <description>Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg</description>
    <arm_group_label>Velcade/Dex/CTX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recently diagnosed WM according to the second 2002 WM international working group&#xD;
&#xD;
          -  Not previously treated, apart from not regularly received by Chlorambucil&#xD;
&#xD;
          -  Aged from 18 to 75 years, both male and female&#xD;
&#xD;
          -  Ability to give signed informed consent&#xD;
&#xD;
          -  Negative pregnancy test at inclusion (if necessary)&#xD;
&#xD;
          -  ECOG from 0 to 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to rituximab or velcade or cyclophosphamide&#xD;
&#xD;
          -  Uncontrolled infection including bacteria, virus and fungus, including active HBV&#xD;
             infection&#xD;
&#xD;
          -  Organic dysfunction: Bilirubin &gt; 1.5 x normal above, Renal failure requiring dialysis,&#xD;
             glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) &gt;&#xD;
             2.5 x normal above&#xD;
&#xD;
          -  Positive HIV serology&#xD;
&#xD;
          -  Serious psychiatric item in the history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fu cheng cheng, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital,Soochow University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fu cheng cheng, PhD</last_name>
    <phone>86-512-67781856</phone>
    <email>evergirl@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital, Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fu chengcheng, Phd</last_name>
      <phone>13962191404</phone>
      <email>evergirl@sina.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 19, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 20, 2016</last_update_submitted>
  <last_update_submitted_qc>November 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 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>Waldenstrom Macroglobulinemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_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/NCT02971982
org study id: myeloma-02
nct id: NCT02971982
lead sponsor: 
has dmc: No
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or
      velcade maintenance therapy, as the investigators try to compare the, very good partial
      remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR +
      partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the
      research.
This is an open-label, single-centre, randomised study, looking at a series of 40 patients up
      to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously
      treated. Patients will receive RCD or PCD combination as induction treatment followed by
      rituximab or velcade maintenance therapy, as the investigators try to compare the, very good
      partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR +
      VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the
      research.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
time frame: 2 years
measure: Investigators try to compare the complete remission (CR) rates at the end of the research.
time frame: 2 years
measure: Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
time frame: 2 years
measure: Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
time frame: 2 yeas
arm group label: rituximab /Dex/CTX
arm group type: Experimental
description: rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28
arm group label: Velcade/Dex/CTX
arm group type: Experimental
description: Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28
intervention type: Drug
intervention name: rituximab /Dexamethasone/cyclophosphamide
description: rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
arm group label: rituximab /Dex/CTX
intervention type: Drug
intervention name: Velcade/Dexamethasone/cyclophosphamide
description: Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg
arm group label: Velcade/Dex/CTX
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Fu cheng cheng, Phd
role: Principal Investigator
affiliation: First Affiliated Hospital,Soochow University
last name: Fu cheng cheng, PhD
phone: 86-512-67781856
email: evergirl@sina.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Waldenstrom Macroglobulinemia
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Cyclophosphamide
mesh term: Rituximab
mesh term: Bortezomib
mesh term: BB 1101
sharing ipd: No