<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/NCT01675245</url>
  </required_header>
  <id_info>
    <org_study_id>CR006373</org_study_id>
    <secondary_id>26866138MMY4031</secondary_id>
    <secondary_id>VEL-CHN-MA-01</secondary_id>
    <nct_id>NCT01675245</nct_id>
  </id_info>
  <brief_title>An Observational Study of Chinese Multiple Myeloma Patients Treated With Velcade</brief_title>
  <official_title>Velcade (Bortezomib for Injection) Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xian-Janssen Pharmaceutical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xian-Janssen Pharmaceutical Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to acquire information on the usage, effectiveness, safety, and&#xD;
      levels of health care resource utilization associated with Velcade therapy in recurrent and&#xD;
      refractory multiple myeloma patients who are initiating Velcade and various combination&#xD;
      therapies within the approved indication in a naturalistic setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a national, multi-center (study conducted in multiple sites), non-interventional (a&#xD;
      scientific study where one or more investigators monitor one or more patients being treated&#xD;
      with the same medication), observational study (a scientific study to make a clear and easy&#xD;
      understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients&#xD;
      treated with Velcade. The study consists of 3 phases, including, screening phase, treatment&#xD;
      phase, and follow up phase. In the screening phase, data will be collected on the basis of&#xD;
      patient's demographic status, components of disease severity assessment, and potential&#xD;
      prognostic factors. Data on prior cancer treatments will be collected retrospectively at&#xD;
      baseline for patients receiving cancer treatment prior to receiving Velcade. In the treatment&#xD;
      phase, Velcade is administered intravenously for a 2-week treatment period followed by a&#xD;
      10-day rest period. Each treatment cycle consists of 21 days. Prospective (in which the&#xD;
      participants are first identified and then followed forward as time passes) observational&#xD;
      data will be collected during treatment with Velcade. In the follow up phase, patients will&#xD;
      be followed for up to three years to document long-term survival data. For patients who&#xD;
      reinitiate Velcade, data collection should follow Velcade treatment period documentation&#xD;
      process. Safety evaluations will be based on the incidence, intensity, and types of adverse&#xD;
      events. The total duration of the study is set prospectively for three years from the date of&#xD;
      the patients' initiation of Velcade.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2006</start_date>
  <completion_date type="Actual">May 2010</completion_date>
  <primary_completion_date type="Actual">May 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Information on treatment sequence for Velcade therapy</measure>
    <time_frame>Baseline (Day -1) to Day 21</time_frame>
    <description>Treatment sequence or the line of therapy will be considered on Velcade utilization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Information on dosage of Velcade</measure>
    <time_frame>Baseline to Day 21</time_frame>
    <description>Dosage of Velcade will be considered on Velcade utilization. The unit of dosage will be milligram per square meter body surface area.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Information on duration of Velcade therapy</measure>
    <time_frame>Baseline to Day 21</time_frame>
    <description>Duration of Velcade therapy will be measured on Velcade utilization. The unit of duration will be number of days or the length of the course of therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Information on patient diagnosis for Velcade therapy</measure>
    <time_frame>Baseline to Day 21</time_frame>
    <description>Diagnosis of patients will be considered on Velcade utilization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with disease response or progression</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to response</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time to response is calculated from the start date of the cycle of Velcade therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to progression</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time to progression is calculated from the date on which response is documented until PD or RCR occurs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survival status</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Survival status is calculated from the start of Velcade therapy until death; to be monitored, to the extent possible, beyond the end of Velcade therapy, up to the end of the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Safety criteria will be considered for new skeletal events (fractures, radiotherapy of bone, operation on the bone, spinal cord compression), infection and haematological toxicity (with greater than or equal to grade 3 using WHO Common Toxicity Criteria [WHO CTC]), and any neurotoxic events by WHO CTC.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of emergency room visits while using Velcade therapy</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of inpatient hospital stays while using Velcade therapy</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of days for each hospital stay</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients on whom therapeutic therapies will be conducted</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients on whom chest radiograph will be conducted</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients on whom whole-body bone scan will be conducted</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients on whom radiograph for designated area will be conducted</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum immunoglobin and M-protein</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>M-protein detected by immunofixation electrophoresis</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Urine light chain M-protein</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone marrow puncture and biopsy</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>β2-microglobulin</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lactate dehydrogenase</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Routine blood examination</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Liver function test</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal function test</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum electrolytes</measure>
    <time_frame>Up to 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients on concomitant medications</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Concomitant medications will be considered as a measure of health care resource utilization associated with Velcade therapy. Concomitant medications include over-the-counter as well as prescription medications, start and stop dates, dosages, and indication. The compliance of concomitant medications will be evaluated by the percentage of patient reported dose over prescribed dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Indications for Velcade therapy</measure>
    <time_frame>Baseline (Day -1)</time_frame>
    <description>Multiple myeloma patients who receive two or more prior treatments and demonstrate disease progression on the most recent treatment will be indicated for Velcade therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sociodemographics for Velcade therapy</measure>
    <time_frame>Baseline</time_frame>
    <description>Sociodemographics of patients will be assessed, at the initiation of Velcade therapy, such as: gender, date of birth, height, weight, highest degree, and career information.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of chronic concomitant disease</measure>
    <time_frame>Baseline</time_frame>
    <description>Chronic concomitant disease will be assessed at the initiation of Velcade therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment history</measure>
    <time_frame>Baseline</time_frame>
    <description>Treatment history will be assessed at the initiation of Velcade therapy. Treatment history includes: confirmation date of diagnosis of multiple myeloma patients or other patients receiving Velcade therapy; names of diseases for patient receiving Velcade therapy; prior treatments for multiple myeloma; outcomes of prior treatments for multiple myeloma.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">532</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Velcade</arm_group_label>
    <description>Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)</description>
    <arm_group_label>Velcade</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with multiple myeloma (based on standard diagnosis criteria), initiating&#xD;
        Velcade therapy within the approved indication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must give informed consent in agreement with local legislation&#xD;
&#xD;
          -  Must not have any contraindication listed in package insert&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients currently participating in another investigational study of Velcade or any&#xD;
             other medication&#xD;
&#xD;
          -  Patients with severe hepatic or renal impairment&#xD;
&#xD;
          -  Patients with platelet count below 25000/μl&#xD;
&#xD;
          -  Patients who are considered disqualified for the study by the investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xian-Janssen Pharmaceutical Ltd., China Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Xian-Janssen Pharmaceutical Ltd.</affiliation>
  </overall_official>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&amp;studyid=1482&amp;filename=CR006373_CSR.pdf</url>
    <description>VELCADE (Bortezomib for Injection) Observational Study</description>
  </link>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>June 10, 2014</last_update_submitted>
  <last_update_submitted_qc>June 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Cancer</keyword>
  <keyword>Velcade</keyword>
  <keyword>Bortezomib</keyword>
  <keyword>Chinese patients</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01675245
org study id: CR006373
secondary id: 26866138MMY4031
secondary id: VEL-CHN-MA-01
nct id: NCT01675245
lead sponsor: 
has dmc: No
The purpose of this study is to acquire information on the usage, effectiveness, safety, and
      levels of health care resource utilization associated with Velcade therapy in recurrent and
      refractory multiple myeloma patients who are initiating Velcade and various combination
      therapies within the approved indication in a naturalistic setting.
This is a national, multi-center (study conducted in multiple sites), non-interventional (a
      scientific study where one or more investigators monitor one or more patients being treated
      with the same medication), observational study (a scientific study to make a clear and easy
      understanding of the cause and effect relationship) of Chinese Multiple Myeloma patients
      treated with Velcade. The study consists of 3 phases, including, screening phase, treatment
      phase, and follow up phase. In the screening phase, data will be collected on the basis of
      patient's demographic status, components of disease severity assessment, and potential
      prognostic factors. Data on prior cancer treatments will be collected retrospectively at
      baseline for patients receiving cancer treatment prior to receiving Velcade. In the treatment
      phase, Velcade is administered intravenously for a 2-week treatment period followed by a
      10-day rest period. Each treatment cycle consists of 21 days. Prospective (in which the
      participants are first identified and then followed forward as time passes) observational
      data will be collected during treatment with Velcade. In the follow up phase, patients will
      be followed for up to three years to document long-term survival data. For patients who
      reinitiate Velcade, data collection should follow Velcade treatment period documentation
      process. Safety evaluations will be based on the incidence, intensity, and types of adverse
      events. The total duration of the study is set prospectively for three years from the date of
      the patients' initiation of Velcade.
observational model: Case-Only
time perspective: Prospective
measure: Information on treatment sequence for Velcade therapy
time frame: Baseline (Day -1) to Day 21
description: Treatment sequence or the line of therapy will be considered on Velcade utilization.
measure: Information on dosage of Velcade
time frame: Baseline to Day 21
description: Dosage of Velcade will be considered on Velcade utilization. The unit of dosage will be milligram per square meter body surface area.
measure: Information on duration of Velcade therapy
time frame: Baseline to Day 21
description: Duration of Velcade therapy will be measured on Velcade utilization. The unit of duration will be number of days or the length of the course of therapy.
measure: Information on patient diagnosis for Velcade therapy
time frame: Baseline to Day 21
description: Diagnosis of patients will be considered on Velcade utilization.
measure: Number of patients with disease response or progression
time frame: Up to 3 years
description: Complete response (CR), near complete response (complete response with positive immunofixation; nCR), partial response (PR), minimal response (MR), stable disease (SD), progressive disease (PD), or relapse from CR (RCR); the methods and criteria used to evaluate the responses will be chosen by the physician and recorded.
measure: Time to response
time frame: Up to 3 years
description: Time to response is calculated from the start date of the cycle of Velcade therapy.
measure: Duration of response
time frame: Up to 3 years
description: Duration of response is calculated from the date on which response is documented until PD, RCR, death, or study termination occurs.
measure: Time to progression
time frame: Up to 3 years
description: Time to progression is calculated from the date on which response is documented until PD or RCR occurs.
measure: Survival status
time frame: Up to 3 years
description: Survival status is calculated from the start of Velcade therapy until death; to be monitored, to the extent possible, beyond the end of Velcade therapy, up to the end of the study period.
measure: Number of patients with adverse events
time frame: Up to 3 years
description: Safety criteria will be considered for new skeletal events (fractures, radiotherapy of bone, operation on the bone, spinal cord compression), infection and haematological toxicity (with greater than or equal to grade 3 using WHO Common Toxicity Criteria [WHO CTC]), and any neurotoxic events by WHO CTC.
measure: Number of emergency room visits while using Velcade therapy
time frame: Up to 3 years
description: Emergency room visits will be considered as a measure of health care resource utilization associated with Velcade therapy.
measure: Number of inpatient hospital stays while using Velcade therapy
time frame: Up to 3 years
description: Inpatient hospital stays and the reasons for hospitalization will be considered as a measure of health care resource utilization associated with Velcade therapy.
measure: Number of days for each hospital stay
time frame: Up to 3 years
description: Days for each hospital stay will be considered as a measure of health care resource utilization associated with Velcade therapy.
measure: Number of patients on whom therapeutic therapies will be conducted
time frame: Up to 3 years
description: Therapeutic therapies (eg: surgery) will be considered as a measure of health care resource utilization associated with Velcade therapy.
measure: Number of patients on whom chest radiograph will be conducted
time frame: Up to 3 years
measure: Number of patients on whom whole-body bone scan will be conducted
time frame: Up to 3 years
measure: Number of patients on whom radiograph for designated area will be conducted
time frame: Up to 3 years
measure: Serum immunoglobin and M-protein
time frame: Up to 3 years
measure: M-protein detected by immunofixation electrophoresis
time frame: Up to 3 years
measure: Urine light chain M-protein
time frame: Up to 3 years
measure: Bone marrow puncture and biopsy
time frame: Up to 3 years
measure: β2-microglobulin
time frame: Up to 3 years
measure: C-reactive protein
time frame: Up to 3 years
measure: Lactate dehydrogenase
time frame: Up to 3 years
measure: Routine blood examination
time frame: Up to 3 years
measure: Liver function test
time frame: Up to 3 years
measure: Renal function test
time frame: Up to 3 years
measure: Serum electrolytes
time frame: Up to 3 years
measure: Number of patients on concomitant medications
time frame: Up to 3 years
description: Concomitant medications will be considered as a measure of health care resource utilization associated with Velcade therapy. Concomitant medications include over-the-counter as well as prescription medications, start and stop dates, dosages, and indication. The compliance of concomitant medications will be evaluated by the percentage of patient reported dose over prescribed dose.
measure: Indications for Velcade therapy
time frame: Baseline (Day -1)
description: Multiple myeloma patients who receive two or more prior treatments and demonstrate disease progression on the most recent treatment will be indicated for Velcade therapy.
measure: Sociodemographics for Velcade therapy
time frame: Baseline
description: Sociodemographics of patients will be assessed, at the initiation of Velcade therapy, such as: gender, date of birth, height, weight, highest degree, and career information.
measure: Number of chronic concomitant disease
time frame: Baseline
description: Chronic concomitant disease will be assessed at the initiation of Velcade therapy.
measure: Treatment history
time frame: Baseline
description: Treatment history will be assessed at the initiation of Velcade therapy. Treatment history includes: confirmation date of diagnosis of multiple myeloma patients or other patients receiving Velcade therapy; names of diseases for patient receiving Velcade therapy; prior treatments for multiple myeloma; outcomes of prior treatments for multiple myeloma.
arm group label: Velcade
description: Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks.
intervention type: Drug
intervention name: No intervention
description: This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)
arm group label: Velcade
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: Study Director
affiliation: Xian-Janssen Pharmaceutical Ltd.
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1482&filename=CR006373_CSR.pdf
description: VELCADE (Bortezomib for Injection) Observational Study
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell