<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/NCT04492371</url>
  </required_header>
  <id_info>
    <org_study_id>EMN-COVID</org_study_id>
    <nct_id>NCT04492371</nct_id>
  </id_info>
  <brief_title>COVID-19 Infection and Multiple Myeloma</brief_title>
  <acronym>EMN-COVID</acronym>
  <official_title>COVID-19 INFECTION IN MULTIPLE MYELOMA PATIENTS: AN EUROPEAN OBSERVATIONAL STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Myeloma Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fondazione EMN Italy Onlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>European Myeloma Network</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>
      Collect in an observational study the outcomes of COVID19 infection in MM patients across&#xD;
      Europe.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronavirus Disease 2019 (COVID-19), caused by a novel coronavirus (SARS-CoV-2), is a highly&#xD;
      contagious disease that appeared in Wuhan, Hubei province of China in December 2019. It has&#xD;
      now spread to multiple countries through infected persons travelling mainly by air. Most of&#xD;
      the infected patients have mild symptoms including fever, fatigue and cough. But in severe&#xD;
      cases, patients can progress rapidly and develop the acute respiratory distress syndrome,&#xD;
      septic shock, metabolic acidosis and coagulopathy including a disseminated intravascular&#xD;
      coagulation (DIC).&#xD;
&#xD;
      Multiple myeloma (MM) is a mature B-cell malignancy largely affecting the older patient with&#xD;
      a median age at presentation of 70 years. The general performance status (PS) and the&#xD;
      presence of comorbidity can identify a group of patients with poor tolerance to treatment, as&#xD;
      well as risks of both bacterial and viral infection. MM patients have benefited significantly&#xD;
      from therapeutic developments, however, the host response biology of the older person,&#xD;
      coupled with a distinct disease biology overlay induces immune dysfunction. For example, the&#xD;
      impact of aging on the human immune system is well documented. In MM it has long-since been&#xD;
      understood that there is a spectrum of immune dysregulation, an important host factor&#xD;
      considered in the &quot;Hallmarks of cancer&quot; theory. In addition, the delivery of anti-MM therapy&#xD;
      includes immune modulating agents such as steroids, proteasome inhibitors and CD38-directed&#xD;
      therapy though not all immune modulation is necessarily detrimental.&#xD;
&#xD;
      As such, myeloma patients are considered a higher risk in the current pandemic with&#xD;
      SARS-COVID19. However, it is not clear whether this is actually the case, and the risk may&#xD;
      not be different to population in general. Equally it may be sub-groups of patients who are&#xD;
      at risk e.g. on treatment versus stable response (plateau), frailty. AS such, this proposal&#xD;
      aims to collect in an observational study, the outcomes of COVID19 infection in MM patients&#xD;
      across Europe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Actual">August 18, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nature of COVID19</measure>
    <time_frame>1 years</time_frame>
    <description>The duration of infection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Costs related to COVID-19</measure>
    <time_frame>1 years</time_frame>
    <description>Costs related to Covid in terms of health resource needs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic anti-cancer therapy subgroup</measure>
    <time_frame>1 years</time_frame>
    <description>Number of infection recovery for each systemic anti-cancer subgroup.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Laboratory values collected at hospitalization</measure>
    <time_frame>1 years</time_frame>
    <description>Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 infection in myeloma patient subgroups</measure>
    <time_frame>1 years</time_frame>
    <description>Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of COVID-19 infection in frail patients</measure>
    <time_frame>1 years</time_frame>
    <description>Number of frail patients with COVID-19 infection and resolution of it.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infection outcome in different countries</measure>
    <time_frame>1 years</time_frame>
    <description>Number of infection and outcome per country.</description>
  </primary_outcome>
  <enrollment type="Actual">1054</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Covid19</condition>
  <condition>Corona Virus Infection</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Multiple Myeloma patients with COVID-19 infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Multiple Myeloma patients&#xD;
&#xD;
          -  COVID-19 infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>General Hopspital Vienna/Medical University</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCL Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Würzburg</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandra Clinical Terapeutics</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Consorziale Policlinico di Bari</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's University Hospital</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04492371
org study id: EMN-COVID
nct id: NCT04492371
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Collect in an observational study the outcomes of COVID19 infection in MM patients across
      Europe.
Coronavirus Disease 2019 (COVID-19), caused by a novel coronavirus (SARS-CoV-2), is a highly
      contagious disease that appeared in Wuhan, Hubei province of China in December 2019. It has
      now spread to multiple countries through infected persons travelling mainly by air. Most of
      the infected patients have mild symptoms including fever, fatigue and cough. But in severe
      cases, patients can progress rapidly and develop the acute respiratory distress syndrome,
      septic shock, metabolic acidosis and coagulopathy including a disseminated intravascular
      coagulation (DIC).

      Multiple myeloma (MM) is a mature B-cell malignancy largely affecting the older patient with
      a median age at presentation of 70 years. The general performance status (PS) and the
      presence of comorbidity can identify a group of patients with poor tolerance to treatment, as
      well as risks of both bacterial and viral infection. MM patients have benefited significantly
      from therapeutic developments, however, the host response biology of the older person,
      coupled with a distinct disease biology overlay induces immune dysfunction. For example, the
      impact of aging on the human immune system is well documented. In MM it has long-since been
      understood that there is a spectrum of immune dysregulation, an important host factor
      considered in the "Hallmarks of cancer" theory. In addition, the delivery of anti-MM therapy
      includes immune modulating agents such as steroids, proteasome inhibitors and CD38-directed
      therapy though not all immune modulation is necessarily detrimental.

      As such, myeloma patients are considered a higher risk in the current pandemic with
      SARS-COVID19. However, it is not clear whether this is actually the case, and the risk may
      not be different to population in general. Equally it may be sub-groups of patients who are
      at risk e.g. on treatment versus stable response (plateau), frailty. AS such, this proposal
      aims to collect in an observational study, the outcomes of COVID19 infection in MM patients
      across Europe.
observational model: Cohort
time perspective: Other
measure: Nature of COVID19
time frame: 1 years
description: The duration of infection.
measure: Costs related to COVID-19
time frame: 1 years
description: Costs related to Covid in terms of health resource needs.
measure: Systemic anti-cancer therapy subgroup
time frame: 1 years
description: Number of infection recovery for each systemic anti-cancer subgroup.
measure: Laboratory values collected at hospitalization
time frame: 1 years
description: Evaluate if recurring haematological and chemistry values are related to infection onset, better or poorer outcome.
measure: COVID-19 infection in myeloma patient subgroups
time frame: 1 years
description: Number of infection in each myeloma patient subgroups and evaluation of the number of recovery per subgroup.
measure: Incidence of COVID-19 infection in frail patients
time frame: 1 years
description: Number of frail patients with COVID-19 infection and resolution of it.
measure: Infection outcome in different countries
time frame: 1 years
description: Number of infection and outcome per country.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: Czechia
country: Germany
country: Greece
country: Italy
country: Netherlands
country: United Kingdom
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: Undecided