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/NCT06028087</url>
    </required_header>
    <id_info>
      <org_study_id>ET0123</org_study_id>
      <nct_id>NCT06028087</nct_id>
    </id_info>
    <brief_title>Real-World Mapping Antithrombotic Regimens in MM Patients on Treatment</brief_title>
    <official_title>Real-World Mapping Antithrombotic Regimens in Multiple Myeloma Patients on Treatment (The MAMMOTH Study of the GIMEMA Working Party on Hemostasis and Thrombosis)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gruppo Italiano Malattie EMatologiche dell'Adulto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gruppo Italiano Malattie EMatologiche dell'Adulto</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about antithrombotic regimens in Multiple&#xD;
        myeloma patients. The main question it aims to answer is the efficacy of different types of&#xD;
        thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous&#xD;
        thromboembolism (VTE).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an observational prospective cohort study aimed at assessing the efficacy of&#xD;
        different types of thromboprophylaxis in MM patients; the setting is the GIMEMA network of&#xD;
        the Italian haematological Centers.&#xD;
  &#xD;
        The observation time for each patient will be of 3 years from the start of the active&#xD;
        treatment for MM. Patients will remain in the study regardless of the stage of disease, type&#xD;
        of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis,&#xD;
        occurrence of thrombosis.&#xD;
  &#xD;
        Four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis,&#xD;
        cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients&#xD;
        receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">December 2028</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>Rate of venous thromboembolism according to different thromboprophylaxis strategies</measure>
      <time_frame>3 years</time_frame>
      <description>Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed:&#xD;
  Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis&#xD;
  Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis&#xD;
  Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis.</description>
    </primary_outcome>
    <enrollment type="Anticipated">736</enrollment>
    <condition>Multiple Myeloma</condition>
    <condition>Diagnosis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with a newly diagnosis of symptomatic Multiple myeloma treated at the&#xD;
          Italian haematological Centers of the GIMEMA network. Patients will be enrolled prior to&#xD;
          any treatment for MM.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age equal to or greater than 18 years of age.&#xD;
  &#xD;
            2. New diagnosis of symptomatic MM according to the CRAB or the SLIM criteria of the&#xD;
               International Myeloma Working Group&#xD;
  &#xD;
            3. First active treatment for MM started after recruitment in the study&#xD;
  &#xD;
            4. Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients having had thrombosis within 6 months before diagnosis of MM&#xD;
  &#xD;
            2. Patients with need of combined antithrombotic regimens (i.e. VKA or DOAC or LMWK and&#xD;
               one or two antiplatelet drugs)&#xD;
  &#xD;
            3. Ongoing first active treatment for MM initiated before the starting of the study.&#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>Valerio De Stefano</last_name>
      <role>Principal Investigator</role>
      <affiliation>Università Cattolica, Fondazione Policlinico A. Gemelli IRCCS, Roma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paola Fazi</last_name>
      <phone>0670390528</phone>
      <email>p.fazi@gimema.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enrico Crea</last_name>
      <phone>0670390514</phone>
      <email>e.crea@gimema.it</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06028087
  org study id: ET0123
  nct id: NCT06028087
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about antithrombotic regimens in Multiple
        myeloma patients. The main question it aims to answer is the efficacy of different types of
        thromboprophylaxis (antiplatelet agents, heparins, oral anticoagulants) in preventing venous
        thromboembolism (VTE).
  This is an observational prospective cohort study aimed at assessing the efficacy of
        different types of thromboprophylaxis in MM patients; the setting is the GIMEMA network of
        the Italian haematological Centers.
  
        The observation time for each patient will be of 3 years from the start of the active
        treatment for MM. Patients will remain in the study regardless of the stage of disease, type
        of treatment (induction, transplantation, maintenance), type of antithrombotic prophylaxis,
        occurrence of thrombosis.
  
        Four cohorts will be identified: cohort 1 will include patients without thromboprophylaxis,
        cohort 2 will include patients receiving antiplatelet agents, cohort 3 will include patients
        receiving heparins, and cohort 4 will include patients receiving oral anticoagulants.
  observational model: Case-Only
  time perspective: Prospective
  measure: Rate of venous thromboembolism according to different thromboprophylaxis strategies
  time frame: 3 years
  description: Efficacy of different thromboprophylaxis strategies vs no thromboprophylaxis in terms of rate of VTE in patients newly diagnosed:
  Comparison of VTE rate in patients treated with antiplatelet agents vs no thromboprophylaxis
  Comparison of VTE rate in patients treated with heparins vs no thromboprophylaxis
  Comparison of VTE rate in patients treated with oral anticoagulants vs no thromboprophylaxis.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Valerio De Stefano
  role: Principal Investigator
  affiliation: Università Cattolica, Fondazione Policlinico A. Gemelli IRCCS, Roma
  last name: Paola Fazi
  phone: 0670390528
  email: p.fazi@gimema.it
  last name: Enrico Crea
  phone: 0670390514
  email: e.crea@gimema.it
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: No