<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/NCT03242460</url>
  </required_header>
  <id_info>
    <org_study_id>PORYOU</org_study_id>
    <nct_id>NCT03242460</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM)</brief_title>
  <acronym>PORYOU</acronym>
  <official_title>The Safety and Efficacy of Pomalidomide in Combination With Cyclophosphamide and Dexamethasone (PCD) in the Transplant-ineligible Patients With Relapsed and/or Refractory Multiple Myeloma (MM) Who Had Lenalidomide Plus Dexamethasone (LD) Following Frontline Bortezomib Combined Chemotherapy, Open-labeled, Multicenter Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kosin University Gospel Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kosin University Gospel Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed&#xD;
      MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse&#xD;
      the second-line LD when the bortezomib-containing treatment failed to salvage the patients.&#xD;
      Patients who have relapsed MM after exposure to the above agents and have progressive disease&#xD;
      have a short life expectancy. Third-line therapy is needed for retrieving the patients&#xD;
      hereafter. And substantial proportion of patients will attain an advanced age. To examine if&#xD;
      time to disease progression is maintained and tolerability is improved with lower&#xD;
      dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is&#xD;
      achieved after 3 months of treatment with the initial dose. Three months later (6 months&#xD;
      after the initial treatment), the response remains in stable disease, 2nd dose reduction&#xD;
      (dexamethasone 10mg or prednisone 50mg) will be carried out.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 12, 2015</start_date>
  <completion_date type="Actual">May 2, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 2019</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>
    <intervention_model_description>the transplant-ineligible patients with Relapsed and/or refractorY multiple myeloma (MM) who had lenalidomide+dexamethasone (LD) following frontline bortezomib combined chemotherapy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Median Progression-free Survival (PFS)</measure>
    <time_frame>2 years follow up</time_frame>
    <description>Kaplan-Meier method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>2 years follow up</time_frame>
    <description>International Myeloma Working Group,( IMWG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>2 years follow up</time_frame>
    <description>Kaplan-Meier method</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety evaluations assessed using Common Terminology Criteria for Adverse Events v4.0</measure>
    <time_frame>2 years follow up</time_frame>
    <description>Common Terminology Criteria for Adverse Events v4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Relapsed and/or refractorY Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Pomalidomide, Dexamethasone, Cyclophosphamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pomalidomide 4mg Days 1-21 Dexamethasone 20mg Days 1, 8, 15, 22 Cyclophosphamide 400mg Days 1, 8, 15</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pomalidomide 4 MG</intervention_name>
    <description>Pomalidomide 4mg Days 1-21</description>
    <arm_group_label>Pomalidomide, Dexamethasone, Cyclophosphamide</arm_group_label>
    <other_name>pomalyst</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone 20mg</intervention_name>
    <description>Dexamethasone 20mg Days 1, 8, 15, 22</description>
    <arm_group_label>Pomalidomide, Dexamethasone, Cyclophosphamide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide 400mg</intervention_name>
    <description>Cyclophosphamide 400mg Days 1, 8, 15</description>
    <arm_group_label>Pomalidomide, Dexamethasone, Cyclophosphamide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have evaluable multiple myeloma with at least one of the following&#xD;
             (within 21 days of starting treatment)&#xD;
&#xD;
               -  Serum M-protein ≥ 0.5g/dL, or&#xD;
&#xD;
               -  In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour,&#xD;
                  or serum free light chai (sFLC) &gt; 100mg/L (involved light chain) and an abnormal&#xD;
                  kappa/Lambda ratio&#xD;
&#xD;
          -  Patients were ineligible for autologous stem cell transplantation&#xD;
&#xD;
          -  Must be relapse refractory to initial therapy with bortezomib, melphalan and prednison&#xD;
             and then lenalidomide plus dexamethasone.&#xD;
&#xD;
          -  Refractoriness is defined as disease progression on treatment or progression within 6&#xD;
             months after the last dose of a given therapy. Relapse is defined according to the&#xD;
             criteria of IMWG&#xD;
&#xD;
          -  Males and females ≥ 18 years of age or &gt; country's legal age for adult consent&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2&#xD;
&#xD;
          -  Patients must meet the following clinical laboratory criteria with 21 days of starting&#xD;
             treatment:&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥&#xD;
                  30,000/mm3 if myeloma involvement in the bone marrow is &gt;50%)&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine&#xD;
                  aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN.&#xD;
&#xD;
               -  Calculated creatinine clearance ≥ 30mL/min or creatinine &lt; 3mg/dL.&#xD;
&#xD;
          -  Written informed consent in accordance with federal, local and institutional&#xD;
             guidelines&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who are lactating or pregnant&#xD;
&#xD;
          -  Multiple Myeloma of IgM subtype&#xD;
&#xD;
          -  Glucocorticoid therapy (prednisolone &gt; 30mg/day or equivalent) within 14 days prior to&#xD;
             informed consent obtained&#xD;
&#xD;
          -  POEMS syndrome, plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L,&#xD;
             Waldenstrom's Macroglobulinaemia, or Patients with known amyloidosis&#xD;
&#xD;
          -  Peripheral neuropathy grade &gt; 2&#xD;
&#xD;
          -  Chemotherapy with approved or investigation anticancer therapeutics within 21 days&#xD;
             prior to starting pomalidomide treatment&#xD;
&#xD;
          -  Focal radiation therapy within 7 days prior to start of pomalidomide. Radiation&#xD;
             therapy to an extended field involving a significant volume of bone marrow within 21&#xD;
             days prior to start of pomalidomide&#xD;
&#xD;
          -  Immunotherapy (excluding steroids) 21 days prior to start of pomalidomide&#xD;
&#xD;
          -  Major surgery (excluding kyphoplasty) within 28 days prior to start of pomalidomide&#xD;
&#xD;
          -  Active congestive heart failure (New York Heart Association [NYHA] Class III or IV),&#xD;
             symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional&#xD;
             intervention. Myocardial infarction within 4 months prior to informed consent obtained&#xD;
&#xD;
          -  Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients&#xD;
             with hepatitis B surface antigen or core antibody receiving and responding to&#xD;
             antiviral therapy directed at hepatitis B: these patients are allowed)&#xD;
&#xD;
          -  Second malignancy within the past 3 years except:&#xD;
&#xD;
               -  Adequately treated basal cell or squamous cell skin cancer&#xD;
&#xD;
               -  Carcinoma in situ of the cervix&#xD;
&#xD;
               -  Breast carcinoma in situ with full surgical resection&#xD;
&#xD;
          -  Patients with steroid or lenalidomide hypersensitivity&#xD;
&#xD;
          -  Patients with pleural effusions requiring thoracentesis or ascites requiring&#xD;
             paracentesis within 14 days prior to starting pomalidomide treatment&#xD;
&#xD;
          -  Any clinically significant medical disease or psychiatric condition that, in the&#xD;
             investigator's opinion, may interfere with protocol adherence or a patient's ability&#xD;
             to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catholic university of korea, Seoul ST. Mary's Hospital.</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kosin University Gospel Hospital</investigator_affiliation>
    <investigator_full_name>Ho Sup Lee</investigator_full_name>
    <investigator_title>MD, PhD. associate professor, Division of hematology-Oncology</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>Dexamethasone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>KMMWP</ipd_description>
  </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/NCT03242460
org study id: PORYOU
nct id: NCT03242460
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Korea, VMP is most commonly used as frontline treatment in patients with newly diagnosed
      MM who were ineligible for high-dose therapy. Recently National Insurance began to reimburse
      the second-line LD when the bortezomib-containing treatment failed to salvage the patients.
      Patients who have relapsed MM after exposure to the above agents and have progressive disease
      have a short life expectancy. Third-line therapy is needed for retrieving the patients
      hereafter. And substantial proportion of patients will attain an advanced age. To examine if
      time to disease progression is maintained and tolerability is improved with lower
      dexamethasone dose, the dose of dexamethasone is reduced when at least a minimal response is
      achieved after 3 months of treatment with the initial dose. Three months later (6 months
      after the initial treatment), the response remains in stable disease, 2nd dose reduction
      (dexamethasone 10mg or prednisone 50mg) will be carried out.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: the transplant-ineligible patients with Relapsed and/or refractorY multiple myeloma (MM) who had lenalidomide+dexamethasone (LD) following frontline bortezomib combined chemotherapy
primary purpose: Treatment
masking: None (Open Label)
measure: Median Progression-free Survival (PFS)
time frame: 2 years follow up
description: Kaplan-Meier method
measure: Objective Response Rate (ORR)
time frame: 2 years follow up
description: International Myeloma Working Group,( IMWG)
measure: Overall survival (OS)
time frame: 2 years follow up
description: Kaplan-Meier method
measure: Safety evaluations assessed using Common Terminology Criteria for Adverse Events v4.0
time frame: 2 years follow up
description: Common Terminology Criteria for Adverse Events v4.0
arm group label: Pomalidomide, Dexamethasone, Cyclophosphamide
arm group type: Experimental
description: Pomalidomide 4mg Days 1-21 Dexamethasone 20mg Days 1, 8, 15, 22 Cyclophosphamide 400mg Days 1, 8, 15
intervention type: Drug
intervention name: Pomalidomide 4 MG
description: Pomalidomide 4mg Days 1-21
arm group label: Pomalidomide, Dexamethasone, Cyclophosphamide
other name: pomalyst
intervention type: Drug
intervention name: Dexamethasone 20mg
description: Dexamethasone 20mg Days 1, 8, 15, 22
arm group label: Pomalidomide, Dexamethasone, Cyclophosphamide
intervention type: Drug
intervention name: Cyclophosphamide 400mg
description: Cyclophosphamide 400mg Days 1, 8, 15
arm group label: Pomalidomide, Dexamethasone, Cyclophosphamide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kosin University Gospel Hospital
investigator full name: Ho Sup Lee
investigator title: MD, PhD. associate professor, Division of hematology-Oncology
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Cyclophosphamide
mesh term: Pomalidomide
sharing ipd: Undecided
ipd description: KMMWP