<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/NCT03234335</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0702</org_study_id>
    <secondary_id>2017-A02180-53</secondary_id>
    <nct_id>NCT03234335</nct_id>
  </id_info>
  <brief_title>High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment</brief_title>
  <acronym>IRMYG</acronym>
  <official_title>A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment (IRMYG Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut de Cancérologie de la Loire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of&#xD;
      more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is&#xD;
      recommended when at least one of the myeloma defining events occurs (CRAB features). Renal&#xD;
      impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM&#xD;
      patients at diagnosis and 40-50% of patients during the course of their disease. To date,&#xD;
      there is no defined consensus for the management of myeloma patients with renal failure. It&#xD;
      is then of clinical importance to better considering available therapeutic options to improve&#xD;
      responses and survival of these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RI is associated with poor prognosis and short median survival (32 months vs 55 months for MM&#xD;
      patients with normal renal function). Thus, RI remains a major challenge for hematologists,&#xD;
      including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and&#xD;
      quality of life. The combination of a proteasome inhibitor and an immunomodulator is the&#xD;
      preferred induction treatment for newly diagnosed transplant-eligible MM patients. After&#xD;
      induction, high-dose therapy with Autologous Stem Cell Transplant (ASCT) is the standard of&#xD;
      care for these patients. However, concerns related to management of comorbidities and&#xD;
      treatment side effects question about therapeutic options for patients with severe renal&#xD;
      damage. Of interest, recent studies argued that high-dose therapy followed by ASCT could be a&#xD;
      feasible and safe method for renal failure MM patients. Yet, these observations on small&#xD;
      sample size patients groups need to be confirmed with standardized conditions. This study&#xD;
      proposes to evaluate the efficacy and the safety of this therapeutic strategy in MM patients&#xD;
      with severe renal impairment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Actual">September 27, 2022</completion_date>
  <primary_completion_date type="Actual">September 29, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Non Relapse Mortality post-transplantation</measure>
    <time_frame>100 days post-transplantation</time_frame>
    <description>Non-relapse mortality at Day +100 post-transplantation will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>2 years post-transplantation</time_frame>
    <description>Overall survival at 2 years post-transplantation will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>2 years post-transplantation</time_frame>
    <description>progression-free survival at 2 years post-transplantation will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of toxicities</measure>
    <time_frame>2 years post-transplantation</time_frame>
    <description>Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence of hematological response</measure>
    <time_frame>6 months</time_frame>
    <description>The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of renal response</measure>
    <time_frame>3 months, 6 months and one year</time_frame>
    <description>Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Renal Failure</condition>
  <arm_group>
    <arm_group_label>Myeloma patients with severe renal impairment</arm_group_label>
    <description>Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation will be followed in this study, and data related to the pathology, treatments and transplantation will be reported.</description>
    <arm_group_label>Myeloma patients with severe renal impairment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Myeloma patients with severe renal impairment suseptible of undergoing autologous&#xD;
        transplantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 66 years-old&#xD;
&#xD;
          -  Patients with symptomatic, measurable and newly diagnosed multiple myeloma associated:&#xD;
&#xD;
          -  Severe renal failure at the time of transplantation (creatinine clearance &lt; 40&#xD;
             ml/min/1.73m², CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration)&#xD;
&#xD;
          -  Partial response after induction treatment&#xD;
&#xD;
          -  For patients who undergo autologous transplantation, absence of known contraindication&#xD;
             for transplantation&#xD;
&#xD;
          -  Absence of amylose&#xD;
&#xD;
          -  Patient affiliated to a social security regimen or beneficiary of the same&#xD;
&#xD;
          -  Signed written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient without at least a partial hematological response following the induction&#xD;
             stage&#xD;
&#xD;
          -  Medical history of previous malignancy&#xD;
&#xD;
          -  Patient under guardianship or deprived of his liberty or any condition that may affect&#xD;
             the patient's ability to understand and sign the informed consent (art. L.1121-6,&#xD;
             L.112-7, L.1211-8, L.1211-9)&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Declining participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>66 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jérôme Cornillon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Pierre et Marie Curie</name>
      <address>
        <city>Alger</city>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EHU Oran</name>
      <address>
        <city>Oran</city>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Sart Tilman</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire d'Amiens</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire d'Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Argenteuil</name>
      <address>
        <city>Argenteuil</city>
        <zip>95100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Côte Basque</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Besançon</name>
      <address>
        <city>Besançon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Boulogne</name>
      <address>
        <city>Boulogne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14 000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cholet</name>
      <address>
        <city>Cholet</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21 079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38 043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69 373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Eloi</name>
      <address>
        <city>Montpellier</city>
        <zip>34 295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54 500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Archet</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75 005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75 013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75 020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75 020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69 495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Bernard</name>
      <address>
        <city>Poitiers</city>
        <zip>86 021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Victor Provo (Roubaix)</name>
      <address>
        <city>Roubaix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42 270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint Quentin</name>
      <address>
        <city>Saint-Quentin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American University of Beirut</name>
      <address>
        <city>Beyrouth</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>May 4, 2023</last_update_submitted>
  <last_update_submitted_qc>May 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Renal Failure</keyword>
  <keyword>Autologous Hematopoietic Stem Cell Transplantation (ASCT)</keyword>
  <keyword>Melphalan</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>
    <mesh_term>Renal Insufficiency</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/NCT03234335
org study id: 2017-0702
secondary id: 2017-A02180-53
nct id: NCT03234335
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of
      more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is
      recommended when at least one of the myeloma defining events occurs (CRAB features). Renal
      impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM
      patients at diagnosis and 40-50% of patients during the course of their disease. To date,
      there is no defined consensus for the management of myeloma patients with renal failure. It
      is then of clinical importance to better considering available therapeutic options to improve
      responses and survival of these patients.
RI is associated with poor prognosis and short median survival (32 months vs 55 months for MM
      patients with normal renal function). Thus, RI remains a major challenge for hematologists,
      including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and
      quality of life. The combination of a proteasome inhibitor and an immunomodulator is the
      preferred induction treatment for newly diagnosed transplant-eligible MM patients. After
      induction, high-dose therapy with Autologous Stem Cell Transplant (ASCT) is the standard of
      care for these patients. However, concerns related to management of comorbidities and
      treatment side effects question about therapeutic options for patients with severe renal
      damage. Of interest, recent studies argued that high-dose therapy followed by ASCT could be a
      feasible and safe method for renal failure MM patients. Yet, these observations on small
      sample size patients groups need to be confirmed with standardized conditions. This study
      proposes to evaluate the efficacy and the safety of this therapeutic strategy in MM patients
      with severe renal impairment.
observational model: Cohort
time perspective: Prospective
measure: Non Relapse Mortality post-transplantation
time frame: 100 days post-transplantation
description: Non-relapse mortality at Day +100 post-transplantation will be reported.
measure: Overall survival
time frame: 2 years post-transplantation
description: Overall survival at 2 years post-transplantation will be reported.
measure: progression-free survival
time frame: 2 years post-transplantation
description: progression-free survival at 2 years post-transplantation will be reported.
measure: Number of toxicities
time frame: 2 years post-transplantation
description: Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.
measure: presence of hematological response
time frame: 6 months
description: The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.
measure: Level of renal response
time frame: 3 months, 6 months and one year
description: Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported.
arm group label: Myeloma patients with severe renal impairment
description: Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation.
intervention type: Other
intervention name: Data collection
description: Myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation will be followed in this study, and data related to the pathology, treatments and transplantation will be reported.
arm group label: Myeloma patients with severe renal impairment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 66 Years
maximum age: N/A
healthy volunteers: No
last name: Jérôme Cornillon, MD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
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country: Algeria
country: Belgium
country: France
country: Lebanon
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Renal Insufficiency