xml: <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/NCT06012383</url>
    </required_header>
    <id_info>
      <org_study_id>BOR.NA.MR.95.IV</org_study_id>
      <nct_id>NCT06012383</nct_id>
    </id_info>
    <brief_title>Alvocade® (Bortezomib) Safety and Effectiveness Study</brief_title>
    <official_title>A Phase IV, Post Marketing, Prospective, Observational Cohort Study to Investigate Safety and Effectiveness of Alvocade® in Iranian Patients With Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NanoAlvand</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NanoAlvand</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a phase IV, post-marketing, observational, cohort study for safety and&#xD;
        effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. No&#xD;
        control groups were considered in the study design. The primary objective of this study was&#xD;
        safety assessment, including the incidence of adverse events (AEs).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a phase IV, post-marketing, observational, cohort study for safety and&#xD;
        effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. Data&#xD;
        were gathered in two booklets, containing information on sixteen injections, which were&#xD;
        filled by the designated physician.&#xD;
  &#xD;
        Exposure to Alvocade® in this study was defined as administration of bortezomib (Alvocade®,&#xD;
        NanoAlvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16&#xD;
        injections).&#xD;
  &#xD;
        The primary objective of this study was safety assessment, including the incidence of adverse&#xD;
        events (AEs).&#xD;
  &#xD;
        This study was single arm and the sample size of this study was 59 patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 2016</start_date>
    <completion_date type="Actual">December 2022</completion_date>
    <primary_completion_date type="Actual">December 2022</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>Safety Assessment</measure>
      <time_frame>up to 6 months</time_frame>
      <description>Safety assessment, including the incidence of AEs. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effectiveness Assessment</measure>
      <time_frame>up to 6 months</time_frame>
      <description>Response categories (Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR), and stringent Complete Response (sCR)) were defined and reported based on the uniform response criteria of the International Myeloma Working Group.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">57</enrollment>
    <condition>Multiple Myeloma, Refractory</condition>
    <arm_group>
      <arm_group_label>NanoAlvand Bortezomib</arm_group_label>
      <description>1.3 mg/m2 Bortezomib, IV infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bortezomib</intervention_name>
      <description>Alvocade® was given with a dose of 1.3 mg/m2.</description>
      <arm_group_label>NanoAlvand Bortezomib</arm_group_label>
      <other_name>Alvocade®</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          A population of 57 Iranian patients diagnosed with multiple myeloma under chemotherapy&#xD;
          regimens with Alvocade® (with a dose of 1.3 mg/m2), were enrolled in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with multiple myeloma were included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  There were no exclusion criteria for this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mani Ramzi, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shiraz University of Medical Sciences, Shiraz, Iran</affiliation>
    </overall_official>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Multiple Myeloma</keyword>
    <keyword>Bortezomib</keyword>
    <keyword>Safety</keyword>
    <keyword>Alvocade</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06012383
  org study id: BOR.NA.MR.95.IV
  nct id: NCT06012383
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a phase IV, post-marketing, observational, cohort study for safety and
        effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. No
        control groups were considered in the study design. The primary objective of this study was
        safety assessment, including the incidence of adverse events (AEs).
  This study is a phase IV, post-marketing, observational, cohort study for safety and
        effectiveness evaluation of Alvocade® use in Iranian patients with multiple myeloma. Data
        were gathered in two booklets, containing information on sixteen injections, which were
        filled by the designated physician.
  
        Exposure to Alvocade® in this study was defined as administration of bortezomib (Alvocade®,
        NanoAlvand) with a dose of 1.3 mg/m2, once every 3 weeks during 2.5 to 5.5 months (16
        injections).
  
        The primary objective of this study was safety assessment, including the incidence of adverse
        events (AEs).
  
        This study was single arm and the sample size of this study was 59 patients.
  observational model: Case-Only
  time perspective: Prospective
  measure: Safety Assessment
  time frame: up to 6 months
  description: Safety assessment, including the incidence of AEs. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
  measure: Effectiveness Assessment
  time frame: up to 6 months
  description: Response categories (Stable Disease (SD), Partial Response (PR), Very Good Partial Response (VGPR), Complete Response (CR), and stringent Complete Response (sCR)) were defined and reported based on the uniform response criteria of the International Myeloma Working Group.
  arm group label: NanoAlvand Bortezomib
  description: 1.3 mg/m2 Bortezomib, IV infusion
  intervention type: Drug
  intervention name: Bortezomib
  description: Alvocade® was given with a dose of 1.3 mg/m2.
  arm group label: NanoAlvand Bortezomib
  other name: Alvocade®
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Mani Ramzi, Prof.
  role: Principal Investigator
  affiliation: Shiraz University of Medical Sciences, Shiraz, Iran
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  mesh term: Bortezomib