<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/NCT02224729</url>
  </required_header>
  <id_info>
    <org_study_id>14D.300</org_study_id>
    <secondary_id>2014-025</secondary_id>
    <nct_id>NCT02224729</nct_id>
  </id_info>
  <brief_title>Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma</brief_title>
  <official_title>Phase II Study of Bendamustine, Bortezomib, and Dexamethasone (BBD) for Newly Diagnosed Patients With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib,&#xD;
      and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used&#xD;
      in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways&#xD;
      to stop the growth of cancer cells, either by killing the cells, by stopping them from&#xD;
      dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells&#xD;
      by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride&#xD;
      with bortezomib and dexamethasone may kill more cancer cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Establish the response rate of induction therapy following 4 cycles of the combination&#xD;
      regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in&#xD;
      patients with newly diagnosed multiple myeloma.&#xD;
&#xD;
      II. Describe the tolerability and toxicities of this regimen. III. Provide one-year&#xD;
      progression-free survival and one-year overall survival data following this therapeutic&#xD;
      strategy.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and&#xD;
      2; bortezomib subcutaneously (SC) on days 1, 8, 15, and 22; and dexamethasone orally (PO) on&#xD;
      days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of&#xD;
      disease progression or unacceptable toxicity. Patients achieving less than a very good&#xD;
      partial response (VGPR) or with more than 10% bone marrow plasmacytosis may receive 2&#xD;
      additional courses.&#xD;
&#xD;
      NOTE: Patients requiring immediate reduction in paraprotein during course 1 only receive&#xD;
      bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib IV on days 1, 4, 8,&#xD;
      and 11; and dexamethasone PO on days 1-4.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 1 year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2014</start_date>
  <completion_date type="Actual">November 17, 2018</completion_date>
  <primary_completion_date type="Actual">April 21, 2016</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>Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd</measure>
    <time_frame>At least 140 days</time_frame>
    <description>ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants That Experience Very Good Partial Remission (VGPR)</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and &gt;90% reduction of M-protein in serum and urine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants That Experience Progression-free Survival (PFS)</measure>
    <time_frame>1 year</time_frame>
    <description>The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Count of Participants That Experience Overall Survival (OS)</measure>
    <time_frame>1 year</time_frame>
    <description>The amount of participants that start treatment with BBd and survive at least one year post treatment completion.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stage I Multiple Myeloma</condition>
  <condition>Stage II Multiple Myeloma</condition>
  <condition>Stage III Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Bendamustine, Bortezomib, Dexamethasone (Standard)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Bendamustine, Bortezomib, Dexamethasone (Standard)</arm_group_label>
    <other_name>Treakisym</other_name>
    <other_name>Ribomustin</other_name>
    <other_name>Levact</other_name>
    <other_name>Treanda</other_name>
    <other_name>SDX-105</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Bendamustine, Bortezomib, Dexamethasone (Standard)</arm_group_label>
    <other_name>PS-341</other_name>
    <other_name>Velcade</other_name>
    <other_name>Cytomib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Bendamustine, Bortezomib, Dexamethasone (Standard)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. New diagnosis of multiple myeloma with no prior history of systemic treatment&#xD;
             (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide,&#xD;
             &lt;= 21 days of the first cycle of a planned regimen&#xD;
&#xD;
          2. &gt;= 18 years of age&#xD;
&#xD;
          3. ECOG &lt;= 3&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
          5. Measurable serum paraprotein on SPEP or serum free light chains and ratio, or&#xD;
             quantifiable Bence-Jones proteinuria on 24 hour urine specimen. If the monoclonal&#xD;
             protein has merged with the beta region we will follow the serum immunoglobulin of the&#xD;
             involved heavy chain and comment on either partial remission (PR, as judged by two&#xD;
             protocol investigators) or complete remission (CR, as defined by the achievement of PR&#xD;
             as above and the resolution of the monoclonal protein by immunofixation in the serum&#xD;
             and urine.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Failure to sign informed consent&#xD;
&#xD;
          2. Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or&#xD;
             plasma cell leukemia&#xD;
&#xD;
          3. History of previously treated smoldering myeloma&#xD;
&#xD;
          4. Grade 3 or above peripheral neuropathy&#xD;
&#xD;
          5. Uncontrolled human immunodeficiency virus (HIV)&#xD;
&#xD;
          6. Active hepatitis A, B or C&#xD;
&#xD;
          7. Pregnant or lactating females&#xD;
&#xD;
          8. Total bilirubin &gt;3 times the upper limit of normal&#xD;
&#xD;
          9. ASLT/ALT &gt; 2.5 times the upper limit of normal&#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>Joanne Filicko-O'Hara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Cancer Center at Thomas Jefferson University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.JeffersonHospital.org</url>
    <description>Jefferson University Hospitals</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>May 7, 2018</results_first_submitted>
  <results_first_submitted_qc>May 7, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2018</results_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>Bortezomib</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
          <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
          <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd</title>
        <description>ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.</description>
        <time_frame>At least 140 days</time_frame>
        <population>4 subjects were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</population>
        <group_list>
          <group group_id="O1">
            <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
            <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd</title>
          <description>ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.</description>
          <population>4 subjects were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0</title>
        <description>All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.</description>
        <time_frame>Up to 1 year</time_frame>
        <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</population>
        <group_list>
          <group group_id="O1">
            <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
            <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0</title>
          <description>All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.</description>
          <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants That Experience Very Good Partial Remission (VGPR)</title>
        <description>Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and &gt;90% reduction of M-protein in serum and urine</description>
        <time_frame>Up to 1 year</time_frame>
        <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</population>
        <group_list>
          <group group_id="O1">
            <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
            <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants That Experience Very Good Partial Remission (VGPR)</title>
          <description>Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and &gt;90% reduction of M-protein in serum and urine</description>
          <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants That Experience Progression-free Survival (PFS)</title>
        <description>The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.</description>
        <time_frame>1 year</time_frame>
        <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</population>
        <group_list>
          <group group_id="O1">
            <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
            <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants That Experience Progression-free Survival (PFS)</title>
          <description>The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.</description>
          <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Count of Participants That Experience Overall Survival (OS)</title>
        <description>The amount of participants that start treatment with BBd and survive at least one year post treatment completion.</description>
        <time_frame>1 year</time_frame>
        <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</population>
        <group_list>
          <group group_id="O1">
            <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
            <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
          </group>
        </group_list>
        <measure>
          <title>Count of Participants That Experience Overall Survival (OS)</title>
          <description>The amount of participants that start treatment with BBd and survive at least one year post treatment completion.</description>
          <population>4 were not evaluable - (1 didn't get any therapy on study, 1 received only first cycle and 2 developed medical issues that took them off study during the first cycle)</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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bendamustine, Bortezomib, Dexamethasone (Standard)</title>
          <description>Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.&#xD;
Bendamustine hydrochloride: Given IV&#xD;
Bortezomib: Given SC&#xD;
Dexamethasone: Given PO</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Syncope episode</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Failure to Thrive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Death- Anaphylactic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Allergic Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint Function Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="24" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Alkaline Phosphate increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>AST increase</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypomagnesium</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="6" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Platelet Count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="14" subjects_affected="7" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>ANC increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjuctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Decreased Visual Field</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal cramping</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Stomach Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Indigestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Change in taste</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hand pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Light headedness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Loss of appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal Congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain at port site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain Knee</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain shoulder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain- side of face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rib pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sore Throat</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Soreness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Allergic Rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection site reaction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gum infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Leg Pain (spasm)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paresthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>peripheral motor neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary Frequency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urinary Tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Swelling L- Breast</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dry cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bruising</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Joanne Filicko, O'Hara</name_or_title>
      <organization>Sidney Kimmel Cancer Center at Thomas Jefferson University</organization>
      <phone>215-955-8874</phone>
      <email>joanne.filicko@jeffersron.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/NCT02224729
org study id: 14D.300
secondary id: 2014-025
nct id: NCT02224729
lead sponsor: 
has dmc: Yes
This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib,
      and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used
      in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways
      to stop the growth of cancer cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells
      by blocking some of the enzymes needed for cell growth. Giving bendamustine hydrochloride
      with bortezomib and dexamethasone may kill more cancer cells.
PRIMARY OBJECTIVES:

      I. Establish the response rate of induction therapy following 4 cycles of the combination
      regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in
      patients with newly diagnosed multiple myeloma.

      II. Describe the tolerability and toxicities of this regimen. III. Provide one-year
      progression-free survival and one-year overall survival data following this therapeutic
      strategy.

      OUTLINE:

      Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and
      2; bortezomib subcutaneously (SC) on days 1, 8, 15, and 22; and dexamethasone orally (PO) on
      days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of
      disease progression or unacceptable toxicity. Patients achieving less than a very good
      partial response (VGPR) or with more than 10% bone marrow plasmacytosis may receive 2
      additional courses.

      NOTE: Patients requiring immediate reduction in paraprotein during course 1 only receive
      bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib IV on days 1, 4, 8,
      and 11; and dexamethasone PO on days 1-4.

      After completion of study treatment, patients are followed up for 1 year.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd
time frame: At least 140 days
description: ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
measure: Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0
time frame: Up to 1 year
description: All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.
measure: Count of Participants That Experience Very Good Partial Remission (VGPR)
time frame: Up to 1 year
description: Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and >90% reduction of M-protein in serum and urine
measure: Count of Participants That Experience Progression-free Survival (PFS)
time frame: 1 year
description: The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
measure: Count of Participants That Experience Overall Survival (OS)
time frame: 1 year
description: The amount of participants that start treatment with BBd and survive at least one year post treatment completion.
arm group label: Bendamustine, Bortezomib, Dexamethasone (Standard)
arm group type: Experimental
description: Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.
intervention type: Drug
intervention name: Bendamustine hydrochloride
description: Given IV
arm group label: Bendamustine, Bortezomib, Dexamethasone (Standard)
other name: Treakisym
other name: Ribomustin
other name: Levact
other name: Treanda
other name: SDX-105
intervention type: Drug
intervention name: Bortezomib
description: Given SC
arm group label: Bendamustine, Bortezomib, Dexamethasone (Standard)
other name: PS-341
other name: Velcade
other name: Cytomib
intervention type: Drug
intervention name: Dexamethasone
description: Given PO
arm group label: Bendamustine, Bortezomib, Dexamethasone (Standard)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joanne Filicko-O'Hara, MD
role: Principal Investigator
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
facility: 
country: United States
url: http://www.JeffersonHospital.org
description: Jefferson University Hospitals
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Bortezomib
mesh term: Bendamustine Hydrochloride
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 