<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/NCT02197221</url>
  </required_header>
  <id_info>
    <org_study_id>13 7045 01</org_study_id>
    <nct_id>NCT02197221</nct_id>
  </id_info>
  <brief_title>Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma</brief_title>
  <acronym>IFM2014-02</acronym>
  <official_title>IFM 2014-02 Study: A Randomized Phase III Study of Bortezomib-Melphalan 200 Conditioning Regimen Versus Melphalan 200 for Frontline Transplant Eligible Patients With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Janssen, LP</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Toulouse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase III multicenter randomized, open-label study comparing the efficacy of a combined high&#xD;
      dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell&#xD;
      transplant in frontline multiple myeloma patients, non-progressive after induction therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Response rates (according to IMWG 2011 criteria)</measure>
    <time_frame>60 days post Autologous Stem Cells Transplantation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival</measure>
    <time_frame>60 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rates (according to IMWG 2011 criteria)</measure>
    <time_frame>post ASCT and consolidation therapy</time_frame>
    <description>Compare response rate after ASCT and after the completion of consolidation therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse event</measure>
    <time_frame>End of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival between the two arms</measure>
    <time_frame>60 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Bortezomib-Melphalan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bortezomib will be administered on days: -6, -3 +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Melphalan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Melphalan will be administered on day -2. The PBSC will be injected on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bortezomib-Melphalan</intervention_name>
    <description>Bortezomib will be administered on days: -6, -3, +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.</description>
    <arm_group_label>Bortezomib-Melphalan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>Melphalan will be administered on day -2. The PBSC will be injected on day 0.</description>
    <arm_group_label>Melphalan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have results from their initial diagnosis available at the time of screening to&#xD;
             confirm all the following :&#xD;
&#xD;
               1. Diagnosis of multiple myeloma according to the diagnostic&#xD;
&#xD;
               2. Symptomatic de novo Multiple Myeloma&#xD;
&#xD;
          -  Be eligible for high-dose therapy with autologous stem cell transplantation&#xD;
&#xD;
          -  Autologous cell graft with a total number of CD 34 cells &gt; or = 5 X 106/kg before&#xD;
             freezing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive disease&#xD;
&#xD;
          -  Females participants pregnant or breast-feeding&#xD;
&#xD;
          -  A known infection by the human immunodeficiency virus&#xD;
&#xD;
          -  An active viral hepatitis B or C&#xD;
&#xD;
          -  Unstable angina or myocardial infarction within 4 months prior to inclusion, heart&#xD;
             failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery&#xD;
             disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or&#xD;
             electrocardiographic evidence of acute ischemia or conduction disturbances grade 3&#xD;
             unless the patient has a pacemaker&#xD;
&#xD;
          -  Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment&#xD;
&#xD;
          -  A history of another malignancy. If cancer was diagnosed more than 10 years and&#xD;
             considered as cured, an authorization may be requested on a case-by-case basis after&#xD;
             discussion with the principal investigator&#xD;
&#xD;
          -  A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel ATTAL, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Murielle ROUSSEL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Toulouse</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ROYER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU AMIENS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DIB, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Angers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>CHAOUI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH ARGENTEUIL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ARAUJO, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH BAYONNE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>FONTAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH BESANCON</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BRECHIGNAC, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOPITAL AVICENNE BOBIGNY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MARIT, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>EVEILLARD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU BREST</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MACRO, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU CAEN</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MALFUSON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CLAMART PERCY-Hôpital Instruction des Armées</affiliation>
  </overall_official>
  <overall_official>
    <last_name>CHALETEIX, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_official>
    <last_name>HUMBRECHT-KRAUT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopitaux Civils de Colmar</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BELHADJ, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Henri Mondor de Creteil</affiliation>
  </overall_official>
  <overall_official>
    <last_name>CAILLOT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU DIJON</affiliation>
  </overall_official>
  <overall_official>
    <last_name>WETTERWALD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH DUNKERQUE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>PEGOURIE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <overall_official>
    <last_name>AGAPE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH LA REUNION-ST DENIS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ZUNIC, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH LA REUNION SAINT PIERRE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LELEU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU LILLE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>JACCARD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU LIMOGES</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KARLIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_official>
    <last_name>NICOLAS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Léon Bérard de LYON</affiliation>
  </overall_official>
  <overall_official>
    <last_name>STOPPA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli Calmettes Marseille</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DORVAUX, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH METZ</affiliation>
  </overall_official>
  <overall_official>
    <last_name>EISENMANN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH MULHOUSE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>HULIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU NANCY</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MOREAU, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LEGROS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU NICE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BENBRAHIM, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH ORLEANS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BOUSCARY, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Cochin Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KUHNOWSKI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Curie Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MOREL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital la Pitié Salpêtrière Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>GARDERET, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Saint Antoine Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ARNULF, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Saint Louis Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LACOTTE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Poitiers</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DELMER, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU REIMS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ESCOFFRE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Rennes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>LENAIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Henri Becquerel de Rouen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>GLAISNER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital René Huguenin - St Cloud</affiliation>
  </overall_official>
  <overall_official>
    <last_name>AUGEL MEUNIER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU ST PRIEST EN JAREZ</affiliation>
  </overall_official>
  <overall_official>
    <last_name>BENBOUBKER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Tours</affiliation>
  </overall_official>
  <overall_official>
    <last_name>RIGAUDEAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CH Versailles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Universitaire Saint Luc</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi - Site Notre-Dame</name>
      <address>
        <city>Charleroi</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Liege</name>
      <address>
        <city>Liege</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dinant-Godinne UCL Namur</name>
      <address>
        <city>Yvoir</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH sud Réunion</name>
      <address>
        <city>Saint Pierre</city>
        <state>ILE DE LA Reunion</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Felix Guyon</name>
      <address>
        <city>St-denis</city>
        <state>ILE DE LA Reunion</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Amiens</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Argenteuil Victor Dupouy</name>
      <address>
        <city>Argenteuil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Bayonne</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital du Haut Lévêque</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU DE BREST Hôpital A.Morvan</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU CAEN</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital d'instruction des armées Percy</name>
      <address>
        <city>Clamart</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Estaing</name>
      <address>
        <city>Clermont-ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux civils de Colmar</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Dijon - Hôpital des Enfants</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général</name>
      <address>
        <city>Dunkerque</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU LILLE- Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon sud</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Mercy - CHR Metz Thionville</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Mulhouse</name>
      <address>
        <city>Mulhouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Nancy</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <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>CH d'Orléans</name>
      <address>
        <city>Orleans</city>
        <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>Hôpital de la Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital St-Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU - Hôpital Jean Bernard</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims- Hôpital R.Debré</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital René Huguenin</name>
      <address>
        <city>St Cloud</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de la Loire Lucien Neuwirth</name>
      <address>
        <city>St-priest-en-jarez</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles-Hôpital André Mignot</name>
      <address>
        <city>Versailles</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Roussel M, Lauwers-Cances V, Macro M, Leleu X, Royer B, Hulin C, Karlin L, Perrot A, Touzeau C, Chretien ML, Rigaudeau S, Dib M, Nicolas-Virelizier E, Escoffre-Barbe M, Belhadj K, Mariette C, Stoppa AM, Araujo C, Doyen C, Fontan J, Kolb B, Garderet L, Brechignac S, Malfuson JV, Jaccard A, Lenain P, Borel C, Hebraud B, Benbrahim O, Dorvaux V, Manier S, Augeul-Meunier K, Vekemans MC, Randriamalala E, Chaoui D, Caers J, Chaleteix C, Benboubker L, Vincent L, Glaisner S, Zunic P, Slama B, Eveillard JR, Humbrecht-Kraut C, Morel V, Mineur P, Eisenmann JC, Demarquette H, Richez V, Vignon M, Caillot D, Facon T, Moreau P, Colin AL, Olivier P, Wuilleme S, Avet-Loiseau H, Corre J, Attal M. Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study. Blood. 2022 May 5;139(18):2747-2757. doi: 10.1182/blood.2021014635. Erratum In: Blood. 2023 Mar 9;141(10):1234.</citation>
    <PMID>35511184</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bortezomib</mesh_term>
    <mesh_term>Melphalan</mesh_term>
  </intervention_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/NCT02197221
org study id: 13 7045 01
nct id: NCT02197221
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Phase III multicenter randomized, open-label study comparing the efficacy of a combined high
      dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell
      transplant in frontline multiple myeloma patients, non-progressive after induction therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Response rates (according to IMWG 2011 criteria)
time frame: 60 days post Autologous Stem Cells Transplantation
measure: overall survival
time frame: 60 months
measure: Response rates (according to IMWG 2011 criteria)
time frame: post ASCT and consolidation therapy
description: Compare response rate after ASCT and after the completion of consolidation therapy
measure: Serious adverse event
time frame: End of study
measure: progression-free survival between the two arms
time frame: 60 months
arm group label: Bortezomib-Melphalan
arm group type: Experimental
description: Bortezomib will be administered on days: -6, -3 +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
arm group label: Melphalan
arm group type: Active Comparator
description: Melphalan will be administered on day -2. The PBSC will be injected on day 0.
intervention type: Drug
intervention name: Bortezomib-Melphalan
description: Bortezomib will be administered on days: -6, -3, +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
arm group label: Bortezomib-Melphalan
intervention type: Drug
intervention name: Melphalan
description: Melphalan will be administered on day -2. The PBSC will be injected on day 0.
arm group label: Melphalan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michel ATTAL, MD, PhD
role: Principal Investigator
affiliation: CHU Toulouse
last name: Murielle ROUSSEL, MD
role: Principal Investigator
affiliation: CHU Toulouse
last name: ROYER, MD
role: Principal Investigator
affiliation: CHU AMIENS
last name: DIB, MD
role: Principal Investigator
affiliation: University Hospital, Angers
last name: CHAOUI, MD
role: Principal Investigator
affiliation: CH ARGENTEUIL
last name: ARAUJO, MD
role: Principal Investigator
affiliation: CH BAYONNE
last name: FONTAN, MD
role: Principal Investigator
affiliation: CH BESANCON
last name: BRECHIGNAC, MD
role: Principal Investigator
affiliation: HOPITAL AVICENNE BOBIGNY
last name: MARIT, Pr
role: Principal Investigator
affiliation: CHU Bordeaux
last name: EVEILLARD, MD
role: Principal Investigator
affiliation: CHU BREST
last name: MACRO, MD
role: Principal Investigator
affiliation: CHU CAEN
last name: MALFUSON, MD
role: Principal Investigator
affiliation: CLAMART PERCY-Hôpital Instruction des Armées
last name: CHALETEIX, MD
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: HUMBRECHT-KRAUT, MD
role: Principal Investigator
affiliation: Hopitaux Civils de Colmar
last name: BELHADJ, MD
role: Principal Investigator
affiliation: CHU Henri Mondor de Creteil
last name: CAILLOT, MD
role: Principal Investigator
affiliation: CHU DIJON
last name: WETTERWALD, MD
role: Principal Investigator
affiliation: CH DUNKERQUE
last name: PEGOURIE, MD
role: Principal Investigator
affiliation: University Hospital, Grenoble
last name: AGAPE, MD
role: Principal Investigator
affiliation: CH LA REUNION-ST DENIS
last name: ZUNIC, MD
role: Principal Investigator
affiliation: CH LA REUNION SAINT PIERRE
last name: LELEU, MD
role: Principal Investigator
affiliation: CHU LILLE
last name: JACCARD, MD
role: Principal Investigator
affiliation: CHU LIMOGES
last name: KARLIN, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: NICOLAS, MD
role: Principal Investigator
affiliation: Centre Léon Bérard de LYON
last name: STOPPA, MD
role: Principal Investigator
affiliation: Institut Paoli Calmettes Marseille
last name: DORVAUX, MD
role: Principal Investigator
affiliation: CH METZ
last name: EISENMANN, MD
role: Principal Investigator
affiliation: CH MULHOUSE
last name: HULIN, MD
role: Principal Investigator
affiliation: CHU NANCY
last name: MOREAU, Pr
role: Principal Investigator
affiliation: CHU Nantes
last name: LEGROS, MD
role: Principal Investigator
affiliation: CHU NICE
last name: BENBRAHIM, MD
role: Principal Investigator
affiliation: CH ORLEANS
last name: BOUSCARY, MD
role: Principal Investigator
affiliation: Hôpital Cochin Paris
last name: KUHNOWSKI, MD
role: Principal Investigator
affiliation: Institut Curie Paris
last name: MOREL, MD
role: Principal Investigator
affiliation: Hôpital la Pitié Salpêtrière Paris
last name: GARDERET, MD
role: Principal Investigator
affiliation: Hôpital Saint Antoine Paris
last name: ARNULF, MD
role: Principal Investigator
affiliation: Hôpital Saint Louis Paris
last name: LACOTTE, MD
role: Principal Investigator
affiliation: CHU Poitiers
last name: DELMER, Pr
role: Principal Investigator
affiliation: CHU REIMS
last name: ESCOFFRE, MD
role: Principal Investigator
affiliation: CHU Rennes
last name: LENAIN, MD
role: Principal Investigator
affiliation: Centre Henri Becquerel de Rouen
last name: GLAISNER, MD
role: Principal Investigator
affiliation: Hôpital René Huguenin - St Cloud
last name: AUGEL MEUNIER, MD
role: Principal Investigator
affiliation: CHU ST PRIEST EN JAREZ
last name: BENBOUBKER, MD
role: Principal Investigator
affiliation: CHU Tours
last name: RIGAUDEAU, MD
role: Principal Investigator
affiliation: CH Versailles
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country: Belgium
country: France
citation: Roussel M, Lauwers-Cances V, Macro M, Leleu X, Royer B, Hulin C, Karlin L, Perrot A, Touzeau C, Chretien ML, Rigaudeau S, Dib M, Nicolas-Virelizier E, Escoffre-Barbe M, Belhadj K, Mariette C, Stoppa AM, Araujo C, Doyen C, Fontan J, Kolb B, Garderet L, Brechignac S, Malfuson JV, Jaccard A, Lenain P, Borel C, Hebraud B, Benbrahim O, Dorvaux V, Manier S, Augeul-Meunier K, Vekemans MC, Randriamalala E, Chaoui D, Caers J, Chaleteix C, Benboubker L, Vincent L, Glaisner S, Zunic P, Slama B, Eveillard JR, Humbrecht-Kraut C, Morel V, Mineur P, Eisenmann JC, Demarquette H, Richez V, Vignon M, Caillot D, Facon T, Moreau P, Colin AL, Olivier P, Wuilleme S, Avet-Loiseau H, Corre J, Attal M. Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study. Blood. 2022 May 5;139(18):2747-2757. doi: 10.1182/blood.2021014635. Erratum In: Blood. 2023 Mar 9;141(10):1234.
PMID: 35511184
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Bortezomib
mesh term: Melphalan