<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/NCT01720043</url>
  </required_header>
  <id_info>
    <org_study_id>HCI57748</org_study_id>
    <nct_id>NCT01720043</nct_id>
  </id_info>
  <brief_title>Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients</brief_title>
  <official_title>Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours&#xD;
      after infusion in patients with multiple myeloma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow Accrual&#xD;
  </why_stopped>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">April 2015</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>Efficacy of Velcade</measure>
    <time_frame>48 hours</time_frame>
    <description>Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>All participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants enrolled</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Velcade</intervention_name>
    <description>Single dose of Velcade (1.0-1.3 mg/m2 dose)</description>
    <arm_group_label>All participants</arm_group_label>
    <other_name>Bortezomib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with the diagnosis of multiple myeloma&#xD;
&#xD;
          -  Patients should have not have received VELCADE for at least 2 weeks before receiving&#xD;
             treatment with VELCADE for platelet aggregation testing&#xD;
&#xD;
          -  Patients are to be instructed not to take aspirin or ibuprofen 7-10 days prior to the&#xD;
             platelet aggregations testing.&#xD;
&#xD;
          -  Voluntary written informed consent before performance of any study-related procedure&#xD;
             not part of normal medical care, with the understanding that consent may be withdrawn&#xD;
             by the subject at any time without prejudice to future medical care.&#xD;
&#xD;
          -  Female subject is either postmenopausal for at least 1 year before the screening&#xD;
             visit, is surgically sterilized or if they are of childbearing potential, agree to&#xD;
             practice 2 effective methods of contraception from the time of signing the informed&#xD;
             consent form through 30 days after the last dose of VELCADE, or agree to completely&#xD;
             abstain from heterosexual intercourse.&#xD;
&#xD;
          -  Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to&#xD;
             1 of the following: practice effective barrier contraception during the entire study&#xD;
             treatment period and through a minimum of 30 days after the last dose of study drug,&#xD;
             or completely abstain from heterosexual intercourse.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have received Velcade within 2 weeks prior to study registration&#xD;
&#xD;
          -  Patient has a platelet count of &lt; 150,000 within 7 days before enrollment.&#xD;
&#xD;
          -  Patient has an absolute neutrophil count of &lt; 1000 within 7 days before enrollment.&#xD;
&#xD;
          -  Patient has &gt; 1.5 x ULN Total Bilirubin&#xD;
&#xD;
          -  Patient has &gt; Grade 2 peripheral neuropathy&#xD;
&#xD;
          -  Patient had myocardial infarction within 6 months prior to enrollment or has New York&#xD;
             Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe&#xD;
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute&#xD;
             ischemia or active conduction system abnormalities. Prior to study entry, any ECG&#xD;
             abnormality at screening must be documented by the investigator as not medically&#xD;
             relevant.&#xD;
&#xD;
          -  Currently receiving medication with Coumadin, heparin, low molecular weight heparin,&#xD;
             or NSAIDS. Concomitant use with any of these medications must be discontinued within&#xD;
             two weeks prior to beginning protocol treatment.&#xD;
&#xD;
          -  Patient has hypersensitivity to VELCADE, boron, or mannitol.&#xD;
&#xD;
          -  Female subject is pregnant or lactating. Confirmation that the subject is not pregnant&#xD;
             must be established by a negative serum pregnancy test result obtained during&#xD;
             screening. Pregnancy testing is not required for postmenopausal or surgically&#xD;
             sterilized women.&#xD;
&#xD;
          -  Female patients who are lactating or have a positive serum pregnancy test during the&#xD;
             screening period, or a positive urine pregnancy test on Day 1 before first dose of&#xD;
             study drug, if applicable.&#xD;
&#xD;
          -  Serious medical or psychiatric illness likely to interfere with participation in this&#xD;
             clinical study.&#xD;
&#xD;
          -  Diagnosed or treated for another malignancy within 2 years of enrollment, with the&#xD;
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of&#xD;
             the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.&#xD;
&#xD;
          -  Participation in clinical trials with other investigational agents not included in&#xD;
             this trial, within 14 days of the start of this trial and throughout the duration of&#xD;
             this trial.&#xD;
&#xD;
          -  Radiation therapy within 3 weeks before randomization. Enrollment of subjects who&#xD;
             require concurrent radiotherapy (which must be localized in its field size) should be&#xD;
             deferred until the radiotherapy is completed and 3 weeks have elapsed since the last&#xD;
             date of therapy.&#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>Tibor Kovacsovics, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Huntsman Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>May 17, 2017</results_first_submitted>
  <results_first_submitted_qc>June 7, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 7, 2017</results_first_posted>
  <last_update_submitted>August 4, 2017</last_update_submitted>
  <last_update_submitted_qc>August 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Bortezomib</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>All Participants</title>
          <description>Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>All participants enrolled&#xD;
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Efficacy of Velcade</title>
        <description>Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.</description>
        <time_frame>48 hours</time_frame>
        <population>One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All participants enrolled&#xD;
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy of Velcade</title>
          <description>Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.</description>
          <population>One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.</population>
          <units>percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Collagen 5.g.ml, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.143" spread="7.244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Collagen 2.g.ml, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.429" spread="7.390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADP.10.M, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.571" spread="6.949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADP.5.M, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.429" spread="7.591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADP.3.M, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.571" spread="16.400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arach.Acid.0.5.mg.ml, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.143" spread="15.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ristocetin1.5.mg.ml, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.429" spread="7.345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ristocetin.0.5.mg.ml, 24 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.429" spread="6.803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Collagen.5.g.mL, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.429" spread="10.130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Collagen.2.g.mL, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.857" spread="10.605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADP.10.M, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.429" spread="7.044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADP.5.M, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.571" spread="10.845"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADP.3.M, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.571" spread="13.587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arach.Acid.0.5.mg.mL, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.286" spread="11.368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ristocetin.1.5.mg.mL, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".0143" spread="9.353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ristocetin.0.5.mg.mL, 48 hrs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.000" spread="4.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Collagen.5.g.ml, 24 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.181</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Collagen.2.g.ml</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.164</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>ADP.10.M, 24 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.132</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>ADP.5.M</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.066</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>ADP.3.M, 24 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.268</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Arach.Acid.0.5.mg.ml</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.106</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Ristocetin.1.5.mg.ml</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.625</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Ristocetin.0.5.mg.ml</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.381</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Collagen.5.g.ml, 48 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.549</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Collagen.2.g.ml, 48 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.838</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>ADP.10.M</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.245</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>ADP.5.M</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.417</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>ADP.3.M, 48 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.770</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Arach.Acid.0.5.mg.ml, 48 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.614</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Ristochetin.1.5.mg.ml</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.969</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Ristocetin.0.5.mg.ml, 48 hrs</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.238</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>All participants enrolled&#xD;
Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>DVT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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>Kimberlee Taylor</name_or_title>
      <organization>Huntsman Cancer Institute</organization>
      <phone>8012135673</phone>
      <email>Kimberlee.Taylor@hci.utah.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/NCT01720043
org study id: HCI57748
nct id: NCT01720043
lead sponsor: 
has dmc: Yes
To evaluate the effect of VELCADE on platelet aggregation at baseline, 24 hours and 48 hours
      after infusion in patients with multiple myeloma
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of Velcade
time frame: 48 hours
description: Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.
arm group label: All participants
arm group type: Experimental
description: All participants enrolled
intervention type: Drug
intervention name: Velcade
description: Single dose of Velcade (1.0-1.3 mg/m2 dose)
arm group label: All participants
other name: Bortezomib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tibor Kovacsovics, MD
role: Principal Investigator
affiliation: Huntsman Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Bortezomib
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 