<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/NCT01731886</url>
  </required_header>
  <id_info>
    <org_study_id>AAAJ2355</org_study_id>
    <nct_id>NCT01731886</nct_id>
    <nct_alias>NCT00777881</nct_alias>
  </id_info>
  <brief_title>Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma</brief_title>
  <official_title>A Randomized Clinical Trial of Lenalidomide (CC-5013) and Dexamethasone With and Without Autologous Peripheral Blood Stem Cell Transplant in Patients With Newly Diagnosed Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is being done to compare the combination of lenalidomide and dexamethasone followed&#xD;
      by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and&#xD;
      dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will&#xD;
      include how the subjects respond to each study treatment combination, and what side effects&#xD;
      are caused by each combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000&#xD;
      deaths each year in the United States. Approximately one third of myeloma patients develop&#xD;
      hypercalcemia and about two thirds present with anemia. As the second most common hematologic&#xD;
      malignancy, myeloma remains incurable. In the last forty years, options for therapy have&#xD;
      included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with&#xD;
      those regimens continues to be inevitable with a median survival of 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">April 11, 2017</completion_date>
  <primary_completion_date type="Actual">April 11, 2017</primary_completion_date>
  <phase>Phase 4</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>Complete Response Rate</measure>
    <time_frame>3 years</time_frame>
    <description>The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Rate (OS)</measure>
    <time_frame>4 years</time_frame>
    <description>To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Rate (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>4 years</time_frame>
    <description>PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous peripheral blood stem cell transplant</intervention_name>
    <description>Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>CC-5013</other_name>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Decadron</other_name>
    <other_name>Hexadrol</other_name>
    <other_name>Dexameth</other_name>
    <other_name>Dexone</other_name>
    <other_name>DXM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stem cell collection</intervention_name>
    <description>Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is &gt;2500 x 109 cells/liter; platelet count is &gt;20 x 103/mm3.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Stem Cell Mobilization</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Evomela</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>G-CSF</intervention_name>
    <description>Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Granulocyte-colony stimulating factor (CSF)</other_name>
    <other_name>Filgrastim</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Cytophosphane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesna</intervention_name>
    <description>Mesna will be provided with the cyclophosphamide.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Mesnex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed Multiple Myeloma, Salmon-Durie Stage II or&#xD;
             III or International Staging System II or III that has not been previously treated.&#xD;
&#xD;
          -  Bone marrow plasmacytosis with &gt; or = 10% plasma cells, or sheets of plasma cells or a&#xD;
             biopsy-proven plasmacytoma.&#xD;
&#xD;
          -  Measurable levels of monoclonal protein (M protein): 1 g/dL Immunoglobulin G (IgG) or&#xD;
             .5 g/dL Immunoglobulin A (IgA) on serum protein electrophoresis or &gt; 200 mg of&#xD;
             monoclonal light chain on a 24 hour urine protein electrophoresis.&#xD;
&#xD;
          -  Age &gt; or = 18 years.&#xD;
&#xD;
          -  Life expectancy of greater than 12 months.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &lt; or = 2 (Karnofsky &gt; or&#xD;
             = 60%).&#xD;
&#xD;
          -  Adequate organ and marrow function as defined below:&#xD;
&#xD;
               -  Hgb &gt; or = 9 g/dL&#xD;
&#xD;
               -  Absolute Neutrophil Count &gt; or = 1,500/ ml&#xD;
&#xD;
               -  Platelets &gt; or = 50,000/mm3&#xD;
&#xD;
               -  Total Bilirubin &lt; or = 1.5 mg/dL&#xD;
&#xD;
               -  Aspartate aminotransferase (AST)(SGOT) / alanine aminotransferase (ALT)(SGPT) &lt;&#xD;
                  or = 2.5 X upper limit of normal (ULN)&#xD;
&#xD;
               -  Creatinine &lt; 2.0 mg/dL&#xD;
&#xD;
               -  Creatinine Clearance &gt; or = 50 ml/min&#xD;
&#xD;
          -  Registered into the mandatory Revlimid REMS® program, and be willing and able to&#xD;
             comply with the requirements of the REMS® program.&#xD;
&#xD;
          -  Females of reproductive potential must adhere to the scheduled pregnancy testing as&#xD;
             required in the Revlimid REMS® program.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Subjects with a history of prior malignancy are eligible provided there is no active&#xD;
             malignancy and a low expectation of recurrence within 6 months.&#xD;
&#xD;
          -  Must be willing and able to take prophylaxis with either aspirin at 81 mg/day or&#xD;
             alternative prophylaxis with either low molecular weight heparin or warfarin as&#xD;
             recommended.&#xD;
&#xD;
          -  Eligible for transplant with an age up to and including 75 years.&#xD;
&#xD;
          -  Subjects in Arm A who are refusing transplant can go onto Arm B and will be evaluated&#xD;
             separately.&#xD;
&#xD;
          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy&#xD;
             test with a sensitivity of at least 50 milli-international units per millilitre&#xD;
             (mIU/mL) within 10 - 14 days prior to and again within 24 hours of prescribing&#xD;
             lenalidomide and must either commit to continued abstinence or 2 acceptable methods of&#xD;
             birth control. FCBP must also agree to ongoing pregnancy testing. Males must agree to&#xD;
             use a latex condom.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have had chemotherapy or radiotherapy for multiple myeloma within 4 weeks of baseline.&#xD;
&#xD;
          -  Receiving any other investigational agents or therapy within 28 days of baseline.&#xD;
&#xD;
          -  Brain metastases.&#xD;
&#xD;
          -  Subjects who are pregnant or breast feeding.&#xD;
&#xD;
          -  History of previous deep vein thrombosis or pulmonary embolism must be on&#xD;
             anticoagulation therapy with low molecular weight heparin or warfarin at therapeutic&#xD;
             dosages (e.g. International Normalized Ratio (INR) 2-3).&#xD;
&#xD;
          -  If a subject is on full-dose anticoagulants, the following criteria should be met for&#xD;
             enrollment:&#xD;
&#xD;
               -  Must not have active bleeding or pathological conditions that carry high risk of&#xD;
                  bleeding (e.g. tumor involving major vessels, known varices).&#xD;
&#xD;
               -  Must not have thrombocytopenia requiring transfusion.&#xD;
&#xD;
               -  Must have a platelet count &gt; 50,000.&#xD;
&#xD;
               -  Must have stable INR between 2-3.&#xD;
&#xD;
          -  Smoldering myeloma or monoclonal gammopathy of undetermined significance.&#xD;
&#xD;
          -  Active, uncontrolled infection.&#xD;
&#xD;
          -  Active, uncontrolled seizure disorder (seizures in the last 6 months).&#xD;
&#xD;
          -  Concurrent use of other anti-cancer agents or treatments.&#xD;
&#xD;
          -  Positive for HIV or infectious hepatitis, type B or C.&#xD;
&#xD;
          -  Hypersensitivity to thalidomide.&#xD;
&#xD;
          -  Any condition, including the presence of laboratory abnormalities, which places the&#xD;
             subject at unacceptable risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanne Lentzsch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>September 27, 2019</results_first_submitted>
  <results_first_submitted_qc>September 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 15, 2019</results_first_posted>
  <disposition_first_submitted>April 1, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>June 17, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 19, 2019</disposition_first_posted>
  <last_update_submitted>January 21, 2020</last_update_submitted>
  <last_update_submitted_qc>January 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Suzanne Lentzsch, MD</investigator_full_name>
    <investigator_title>Associate Clinical Professor of Clinical Medicine</investigator_title>
  </responsible_party>
  <keyword>Stem cell transplant</keyword>
  <keyword>plasma cell myeloma</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>
  <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>Melphalan</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>After completion of the study.</ipd_time_frame>
    <ipd_access_criteria>All data will be coded with study identifiers.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 19, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT01731886/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
          <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Autologous peripheral blood stem cell transplant: Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.&#xD;
Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.&#xD;
Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.&#xD;
Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is &gt;2500 x 109 cells/liter; platelet count is &gt;20 x 103/mm3.&#xD;
Melphalan: Subjects undergoing autologous peripheral blood stem cell transplant will receive</description>
        </group>
        <group group_id="P2">
          <title>Arm B: Low-dose Dexamethasone</title>
          <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.&#xD;
Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.&#xD;
Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is &gt;2500 x 109 cells/liter; platelet count is &gt;20 x 103/mm3.&#xD;
Cyclophosphamide: Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.&#xD;
Mesna: Mesna will be provided with the cyclophosphamide.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Never started treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
          <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
        </group>
        <group group_id="B2">
          <title>Arm B: Low-dose Dexamethasone</title>
          <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ISS Stage</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Stage 1(B2M &lt;3.5 mg/L and serum albumin ≥3.5 g/dL)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage 2(Neither stage I nor stage III)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage 3(B2M ≥5.5 mg/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Response Rate</title>
        <description>The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).</description>
        <time_frame>3 years</time_frame>
        <population>1 participant in Arm B never started treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
            <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Low-dose Dexamethasone</title>
            <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate</title>
          <description>The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).</description>
          <population>1 participant in Arm B never started treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival Rate (OS)</title>
        <description>To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</description>
        <time_frame>4 years</time_frame>
        <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
            <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Low-dose Dexamethasone</title>
            <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Only includes subjects who received drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival Rate (OS)</title>
          <description>To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</description>
          <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.8" lower_limit="64.0" upper_limit="95.6"/>
                    <measurement group_id="O2" value="78.9" lower_limit="60.6" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival Rate (OS)</title>
        <description>To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</description>
        <time_frame>2 years</time_frame>
        <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
            <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Low-dose Dexamethasone</title>
            <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Only includes subjects who received drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival Rate (OS)</title>
          <description>To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</description>
          <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="95" upper_limit="100"/>
                    <measurement group_id="O2" value="94.7" lower_limit="85.4" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
        <time_frame>4 years</time_frame>
        <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
            <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Low-dose Dexamethasone</title>
            <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Only includes subjects who received drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
          <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.0" lower_limit="17.2" upper_limit="54.8"/>
                    <measurement group_id="O2" value="31.6" lower_limit="10.7" upper_limit="52.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
        <time_frame>2 years</time_frame>
        <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
            <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
          </group>
          <group group_id="O2">
            <title>Arm B: Low-dose Dexamethasone</title>
            <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Only includes subjects who received drug.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.</description>
          <population>Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" lower_limit="32.4" upper_limit="71.6"/>
                    <measurement group_id="O2" value="47.4" lower_limit="24.9" upper_limit="69.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm A: Low-dose Dexamethasone + Stem Cell Transplantation</title>
          <description>Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).</description>
        </group>
        <group group_id="E2">
          <title>Arm B: Low-dose Dexamethasone</title>
          <description>Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).&#xD;
Only includes subjects who received drug.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Myelodysplastic Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infection with Grade 3 or 4 Neutrophils</sub_title>
                <description>Anal/Perianal</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic Event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="14" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Decreased Neutrophil Count</sub_title>
                <counts group_id="E1" events="22" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Decreased WBC Count</sub_title>
                <counts group_id="E1" events="13" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E2" events="7" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Decreased Platelet Count</sub_title>
                <counts group_id="E1" events="24" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abnormal Neutrophils/Granulocytes (ANC/AGC)</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" events="26" subjects_affected="7" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abnormal Leukocytes</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abnormal Platelet Count</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="12" subjects_affected="4" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abnormal Hemoglobin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Decreased Lymphocyte Count</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" events="11" subjects_affected="5" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Increased Alanine Aminotransferase</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and Connective Tissue Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Suzanne Lentzsch, MD, PhD, Professor of Medicine</name_or_title>
      <organization>Columbia University</organization>
      <phone>646-317-4840</phone>
      <email>sl3440@cumc.columbia.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01731886
org study id: AAAJ2355
nct id: NCT01731886
nct alias: NCT00777881
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The study is being done to compare the combination of lenalidomide and dexamethasone followed
      by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and
      dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will
      include how the subjects respond to each study treatment combination, and what side effects
      are caused by each combination.
Multiple myeloma is a malignant plasma cell proliferative disorder responsible for 11, 000
      deaths each year in the United States. Approximately one third of myeloma patients develop
      hypercalcemia and about two thirds present with anemia. As the second most common hematologic
      malignancy, myeloma remains incurable. In the last forty years, options for therapy have
      included melphalan-prednisone, anthracyclines, and vinca alkaloids; however, relapse with
      those regimens continues to be inevitable with a median survival of 3 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Response Rate
time frame: 3 years
description: The primary objective of this study is to determine the complete response rate of lenalidomide and low-dose dexamethasone versus that of lenalidomide and low-dose dexamethasone followed by autologous peripheral blood stem cell transplant in patients with newly diagnosed multiple myeloma (will include unconfirmed complete response (CR), CR and stringent complete response (sCR)).
measure: Overall Survival Rate (OS)
time frame: 4 years
description: To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
measure: Overall Survival Rate (OS)
time frame: 2 years
description: To compare overall survival in subjects receiving autologous peripheral blood stem cell transplant after undergoing induction therapy with lenalidomide and dexamethasone versus in those receiving only lenalidomide and dexamethasone, followed by lenalidomide maintenance in both arms. Only patients who achieved at least a partial response (PR) following 4 cycles of induction were included in the analysis.
measure: Progression Free Survival (PFS)
time frame: 4 years
description: PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
measure: Progression Free Survival (PFS)
time frame: 2 years
description: PFS is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
arm group label: Arm A
arm group type: Active Comparator
description: Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by steam cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
arm group label: Arm B
arm group type: Active Comparator
description: Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).
intervention type: Procedure
intervention name: Autologous peripheral blood stem cell transplant
description: Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
arm group label: Arm A
intervention type: Drug
intervention name: Lenalidomide
description: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
arm group label: Arm A
arm group label: Arm B
other name: CC-5013
other name: Revlimid
intervention type: Drug
intervention name: Dexamethasone
description: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
arm group label: Arm A
arm group label: Arm B
other name: Decadron
other name: Hexadrol
other name: Dexameth
other name: Dexone
other name: DXM
intervention type: Procedure
intervention name: Stem cell collection
description: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
arm group label: Arm A
arm group label: Arm B
other name: Stem Cell Mobilization
intervention type: Drug
intervention name: Melphalan
description: Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
arm group label: Arm A
other name: Evomela
intervention type: Drug
intervention name: G-CSF
description: Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
arm group label: Arm A
other name: Granulocyte-colony stimulating factor (CSF)
other name: Filgrastim
intervention type: Drug
intervention name: Cyclophosphamide
description: Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
arm group label: Arm A
arm group label: Arm B
other name: Cytophosphane
intervention type: Drug
intervention name: Mesna
description: Mesna will be provided with the cyclophosphamide.
arm group label: Arm A
arm group label: Arm B
other name: Mesnex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne Lentzsch, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Suzanne Lentzsch, MD
investigator title: Associate Clinical Professor of Clinical Medicine
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Cyclophosphamide
mesh term: Melphalan
mesh term: Lenalidomide
mesh term: Lenograstim
sharing ipd: Yes
ipd description: Individual participant data (IPD) will be coded and shared with the University of Pittsburgh at the end of the trial.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: After completion of the study.
ipd access criteria: All data will be coded with study identifiers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 