<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/NCT02985333</url>
  </required_header>
  <id_info>
    <org_study_id>MM-2014</org_study_id>
    <nct_id>NCT02985333</nct_id>
  </id_info>
  <brief_title>Paclitaxel,Cyclophosphamide and Dexamethasone for Relapsed or Refractory Multiple Myeloma</brief_title>
  <official_title>Efficacy and Safety of Paclitaxel/Cyclophosphamide/Dexamethasone to Treat Patients With Relapsed or Refractory Multiple MyelomaRefractory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination&#xD;
      with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple&#xD;
      myeloma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment for relapsed/refractory multiple myeloma (MM)remains a crucial challenge.The&#xD;
      investigators have previously shown that the combination of paclitaxel and cyclophosphamide&#xD;
      acts synergistically to induce apoptosis of myeloma cells in vitro. Based on these&#xD;
      preclinical studies, the investigators initiated a phase II clinical trial of paclitaxel 175&#xD;
      mg/m(2) IV over 3 h d1 combined with cyclophosphamide 200 mg/m(2) IV over 30-60 min d1,3,5&#xD;
      and dexamethasone 20mg IV over 30-60 min d1-4 in patients with relapsed or refractory MM.&#xD;
      This regimen was administered every four weeks for a total of six cycles&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>30 months</time_frame>
    <description>ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>30 months</time_frame>
    <description>PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>30 months</time_frame>
    <description>OS, defined as time from first dose of study treatment to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments</measure>
    <time_frame>30 months</time_frame>
    <description>Safety of combination therapy as assessed by toxicity, which will be assessed using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale for Adverse Events and for laboratory assessments (v4.03) that include biochemistry, hematology, urinalysis; special safety assessments that include LVEF, Thyroid function Creatinine clearance and ECGs (electrocardiograms).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Relapse/Refractory Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>paclitaxel 175 mg/m(2) IV over 3 h d1,cyclophosphamide 200 mg/m(2) IV d1,3,5 and dexamethasone 20mg IV d1-4 in patients with relapsed or refractory MM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel 170 mg/m(2) IV over 3 h d1</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Taxol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide 200mgmg/m(2) IV d1,3,5</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>cytoxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone 20mg iv d1-4</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>hexadecadrol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has a previous diagnosis of multiple myeloma&#xD;
&#xD;
          -  Patient requires retreatment for multiple myeloma&#xD;
&#xD;
          -  Subject has measurable disease as defined by &gt; 0.5 g/dL serum monoclonal protein, &gt;10&#xD;
             mg/dL involved serum free light chain (either kappa or lambda) provided that the serum&#xD;
             free light chain ratio is abnormal, &gt;0.2 g/24 hrs urinary M-protein excretion, and/or&#xD;
             measurable plasmacytoma(s) of at least 1cm in greatest dimension as measured by either&#xD;
             CT scanning or MRI&#xD;
&#xD;
          -  Subject has a Karnofsky performance status ≥60% (&gt;50% if due to bony involvement of&#xD;
             myeloma (see Appendix IV)&#xD;
&#xD;
          -  Subject has a life expectancy ≥ 3 months&#xD;
&#xD;
          -  Subjects must meet the following laboratory parameters:&#xD;
&#xD;
        Absolute neutrophil count (ANC) ≥750 cells/mm3 (1.0 x 109/L) Hemoglobin ≥ 7 g/dL Platelet&#xD;
        count ≥ 75,000/mm3 (30 x 109/L if extensive bone marrow infiltration) Serum SGOT/AST &lt;3.0 x&#xD;
        upper limits of normal (ULN) Serum SGPT/ALT &lt;3.0 x upper limits of normal (ULN) Serum total&#xD;
        bilirubin &lt;2.0 mg/dL (34 µmol/L) Creatinine clearance ≥ 45 cc/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has immeasurable MM (no measurable monoclonal protein, free light chains in&#xD;
             blood or urine, or measureable plasmacytoma on radiologic scanning)&#xD;
&#xD;
          -  Subject has a prior history of other malignancies unless disease-free for ≥ 5 years,&#xD;
             except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the&#xD;
             cervix or breast, or localized prostate cancer with Gleason score &lt; 7 with stable&#xD;
             prostate specific antigen (PSA) levels&#xD;
&#xD;
          -  Subject has had myocardial infarction within 6 months prior to enrollment, or NYHA&#xD;
             (New York Hospital Association) Class III or IV heart failure (see Appendix VI),&#xD;
             Ejection Fraction &lt; 35%, uncontrolled angina, severe uncontrolled ventricular&#xD;
             arrhythmias, electrocardiographic evidence of acute ischemia or active conduction&#xD;
             system abnormalities&#xD;
&#xD;
          -  Female subject who is pregnant or lactating&#xD;
&#xD;
          -  Subject has known HIV infection&#xD;
&#xD;
          -  Subject has known active hepatitis B or hepatitis C infection&#xD;
&#xD;
          -  Subject has active viral or bacterial infections or any coexisting medical problem&#xD;
             that would significantly increase the risks of this treatment program&#xD;
&#xD;
          -  Subject is unable to reliably take oral medications&#xD;
&#xD;
          -  Subject has known hypersensitivity to dexamethasone,cyclophosphamide,paclitaxel&#xD;
&#xD;
          -  Subject has a history of thromboembolic event within the past 4 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Subject has any clinically significant medical or psychiatric disease or condition&#xD;
             that, in the investigator's opinion, may interfere with protocol adherence or a&#xD;
             subject's ability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yue lu, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>hematological oncology department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>May 8, 2018</last_update_submitted>
  <last_update_submitted_qc>May 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>wanghua</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>paclitaxe,cyclophosphamide,dexamethasone, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Cyclophosphamide</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/NCT02985333
org study id: MM-2014
nct id: NCT02985333
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the efficacy and safety of paclitaxel in combination
      with cyclophosphamide and dexamethasone in chinese patients with relapsed/refractory multiple
      myeloma.
Treatment for relapsed/refractory multiple myeloma (MM)remains a crucial challenge.The
      investigators have previously shown that the combination of paclitaxel and cyclophosphamide
      acts synergistically to induce apoptosis of myeloma cells in vitro. Based on these
      preclinical studies, the investigators initiated a phase II clinical trial of paclitaxel 175
      mg/m(2) IV over 3 h d1 combined with cyclophosphamide 200 mg/m(2) IV over 30-60 min d1,3,5
      and dexamethasone 20mg IV over 30-60 min d1-4 in patients with relapsed or refractory MM.
      This regimen was administered every four weeks for a total of six cycles
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: 30 months
description: ORR is defined as the proportion of patients with CR, nCR or partial response (PR) based on modified EBMT criteria per investigator assessment
measure: Progression Free Survival (PFS)
time frame: 30 months
description: PFS, defined as time from first dose of study treatment to progression or death due to any cause, as assessed by investigator
measure: Overall survival (OS)
time frame: 30 months
description: OS, defined as time from first dose of study treatment to death
measure: Safety of combination therapy assessed using the National Cancer institute-Common Toxicology Criteria (NCI-CTC) grade scale for AEs and Lab assessments
time frame: 30 months
description: Safety of combination therapy as assessed by toxicity, which will be assessed using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale for Adverse Events and for laboratory assessments (v4.03) that include biochemistry, hematology, urinalysis; special safety assessments that include LVEF, Thyroid function Creatinine clearance and ECGs (electrocardiograms).
arm group label: Intervention
arm group type: Experimental
description: paclitaxel 175 mg/m(2) IV over 3 h d1,cyclophosphamide 200 mg/m(2) IV d1,3,5 and dexamethasone 20mg IV d1-4 in patients with relapsed or refractory MM.
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel 170 mg/m(2) IV over 3 h d1
arm group label: Intervention
other name: Taxol
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide 200mgmg/m(2) IV d1,3,5
arm group label: Intervention
other name: cytoxan
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone 20mg iv d1-4
arm group label: Intervention
other name: hexadecadrol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: yue lu, MD.
role: Principal Investigator
affiliation: hematological oncology department
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: wanghua
investigator title: professor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Paclitaxel
mesh term: Cyclophosphamide
sharing ipd: No