<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/NCT01685814</url>
  </required_header>
  <id_info>
    <org_study_id>DSMM XIV</org_study_id>
    <secondary_id>2009-016616-21</secondary_id>
    <nct_id>NCT01685814</nct_id>
  </id_info>
  <brief_title>Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance</brief_title>
  <official_title>Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance - A Randomized Multicenter Phase III Trial by Deutsche Studiengruppe Multiples Myelom (DSMM XIV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuerzburg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ClinAssess GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Celgene Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Wuerzburg University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD)&#xD;
      as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being&#xD;
      considered a novel &quot;standard&quot; as an induction protocol, since response in general occurs&#xD;
      early after starting treatment we decided to choose three cycles of either induction regimen.&#xD;
&#xD;
      Together with the &quot;novel compounds&quot;, tandem high-dose melphalan is still the standard of&#xD;
      care; it seems desirable to re-address the question of the number of transplant (single vs.&#xD;
      double high-dose melphalan) procedures required in the context of triplet-induction protocols&#xD;
      utilizing at least one of the novel compounds.&#xD;
&#xD;
      Thus, the question to be asked in the current protocol is whether immediate lenalidomide&#xD;
      maintenance (i.e. following one cycle of high-dose therapy) as an investigational agent will&#xD;
      result in identical progression free survival (PFS) when compared to tandem high-dose&#xD;
      melphalan with deferred maintenance therapy.&#xD;
&#xD;
      Despite induction with novel compounds, approximately 25 - 40% of patients will be in less&#xD;
      than very good partial response. Very recently, achievement of less than VGPR was confirmed&#xD;
      to negatively impact on both PFS as well as overall survival (OS). Therefore, allogeneic stem&#xD;
      cell transplantation is considered the standard of care in patients with suboptimal response&#xD;
      to a first autograft.&#xD;
&#xD;
      In the current protocol, the standard for favourable responders (tandem-autologous&#xD;
      transplant) is combined with 3 years of lenalidomide maintenance. This approach will be&#xD;
      investigated for patients with less than VGPR following a first autotransplant and compared&#xD;
      to the current standard of intensification in poor responders (allogeneic transplantation).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Actual">September 2016</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>The primary efficacy endpoint for the induction phase is the rate of patients with CR at first restaging</measure>
    <time_frame>within 8 days after end of last induction cycle ((Day 92(RAD); Day 71(VRD))</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>In the consolidation phase the primary efficacy endpoint for comparison II (response &lt;VGPR after first ASCT) is the PFS rate</measure>
    <time_frame>3 years after the first ASCT, calculated from day 1 of ASCT.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR following 3 cycles of induction treatment (VRD vs RAD)</measure>
    <time_frame>within 8 days after end of last induction cycle</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CR and ORR at the end of the whole treatment programme</measure>
    <time_frame>at the end of the whole treatment programme (approx. 8 years)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>8 years from study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence, severity and relationship of SAEs</measure>
    <time_frame>30 days post last dosing of study drug</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of hospital stays and hospitalization days</measure>
    <time_frame>within two years from second restaging</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">406</enrollment>
  <condition>Previously Untreated Symptomatic Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>single stem cell transplant, 3-year lenalidomide maintenance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tandem autologous transplant, lenalidomide maintenance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>allogeneic stem cell transplant, lenalidomide maintenance</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tandem autologous transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm D</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide, Bortezomib</intervention_name>
    <description>Induction: two versus one novel drug maintenance: lenalidomide as a maintenance therapy</description>
    <arm_group_label>allogeneic stem cell transplant, lenalidomide maintenance</arm_group_label>
    <arm_group_label>single stem cell transplant, 3-year lenalidomide maintenance</arm_group_label>
    <arm_group_label>tandem autologous transplant</arm_group_label>
    <arm_group_label>tandem autologous transplant, lenalidomide maintenance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>autologous stem cell transplant</intervention_name>
    <arm_group_label>allogeneic stem cell transplant, lenalidomide maintenance</arm_group_label>
    <arm_group_label>single stem cell transplant, 3-year lenalidomide maintenance</arm_group_label>
    <arm_group_label>tandem autologous transplant</arm_group_label>
    <arm_group_label>tandem autologous transplant, lenalidomide maintenance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>allogeneic stem cell transplant</intervention_name>
    <arm_group_label>allogeneic stem cell transplant, lenalidomide maintenance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Understand and voluntarily sign an informed consent form&#xD;
&#xD;
          -  Patients willing and able to undergo autologous and allogeneic transplantation&#xD;
&#xD;
          -  no previous systemic therapy for the treatment of multiple myeloma (dexamethasone at a&#xD;
             cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant chemotherapy,&#xD;
             local irradiation of bone lesions; and surgical intervention is accepted as&#xD;
             pretreatment)&#xD;
&#xD;
          -  Newly diagnosed multiple myeloma according to common diagnostic criteria including&#xD;
             presence of CRAB and measurable disease parameters&#xD;
&#xD;
          -  Cardiac ejection fraction (LVEF) of at least 50%&#xD;
&#xD;
          -  Corrected DLCO of at least 50% ; alternatively pO2 [art.] of at least 70mmHg&#xD;
&#xD;
          -  Karnofsky performance status of greater or equal to 50%&#xD;
&#xD;
          -  adequate bone marrow function&#xD;
&#xD;
          -  adequate serum chemistry values&#xD;
&#xD;
          -  Use of adequate contraception for female subjects with childbearing potential and male&#xD;
             subjects&#xD;
&#xD;
          -  Bone marrow sample available for analysis of molecular cytogenetics&#xD;
&#xD;
          -  Able to administer low molecular-weight heparin as a prophylactic anticoagulation&#xD;
             therapy for the first three months(applicable for subjects randomized to RAD) and able&#xD;
             to administer ASS 100 mg/d (applicable for subjects randomized to VRD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that&#xD;
             would prevent the subject from signing the informed consent form&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Any condition, including the presence of laboratory abnormalities, which places the&#xD;
             subject at unacceptable risk&#xD;
&#xD;
          -  History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolled&#xD;
             angina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis or&#xD;
             peri-/myocarditis&#xD;
&#xD;
          -  Use of any other experimental drug or therapy within 28 days of baseline&#xD;
&#xD;
          -  Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14&#xD;
             days before enrollment&#xD;
&#xD;
          -  Known intolerance of boron&#xD;
&#xD;
          -  Hypersensitivity to acyclovir or similar anti-viral drug&#xD;
&#xD;
          -  Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in&#xD;
             situ cervical, breast or prostate cancer&#xD;
&#xD;
          -  HIV positive, active hepatitis B, C or D viral infection, known CMV&#xD;
             reactivation/active infection, EBV reactivation/active infection or treponema pallidum&#xD;
             infection&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Non-secretory MM&#xD;
&#xD;
          -  Clinically relevant active infection or serious co-morbid medical conditions&#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>Stefan Knop, MD</last_name>
    <role>Study Director</role>
    <affiliation>Wuerzburg University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hermann Einsele, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuerzburg University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Aachen, Med. Klinik IV, Hämatologie u. Onkologie</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schön Klinik Starnberger See, Hämatologie und Onkologie</name>
      <address>
        <city>Berg</city>
        <zip>82335</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Campus Virchow-Klinikum, Hämatologie, Onkologie u. Tumorimmunologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bremen-Mitte gGmbH, Klinik für Innere Medizin I</name>
      <address>
        <city>Bremen</city>
        <zip>28177</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik I</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen, Medizinische Klinik 5</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malteser Krankenhaus St. Franziskus-Hospital, medizinische Klinik I</name>
      <address>
        <city>Flensburg</city>
        <zip>24939</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johann Woflgang Goethe Universität, Frankfurt am Mai</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Frankfurt (Oder) GmbH Medizinische Klinik I</name>
      <address>
        <city>Frankfurt/Oder</city>
        <zip>15236</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Freiburg, Abteilung für Innere Medizin I</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C</name>
      <address>
        <city>Greifswald</city>
        <zip>17475</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Marien-Hospital gem. GmbHKna</name>
      <address>
        <city>Hamm</city>
        <zip>59071</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes Innere Medizin I</name>
      <address>
        <city>Homburg/Saar</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Friedrich-Schiller-Universität Jena, Klinikum für Innrere Medizin II</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Karlsruhe Medizinische Klinik III, Abt. Hämatologie u. Onkologie</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein Campus Kiel, II. Med. Poliklinik</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Medizinische Klinik und Poliklinik II im städtischen Krankenhaus Kiel</name>
      <address>
        <city>Kiel</city>
        <zip>24116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stiftungsklinikum Mittelrhein GmbH, Klinik für Innere Medizin</name>
      <address>
        <city>Koblenz</city>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Medizinische Klinik I</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mannheim medizinische Klinik III</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Schwabing</name>
      <address>
        <city>München</city>
        <zip>80804</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München-Großhadern</name>
      <address>
        <city>München</city>
        <zip>81366</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>III. Med. Klinik und Poliklinik, Klinikum rechts der Isar der TU München</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster, Medizinische Klinik u. Poliklinik A</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Nürnberg Nord, 5. Medizinische LKinik, Onkologie/Hämatologie</name>
      <address>
        <city>Nürnberg</city>
        <zip>90419</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg GmbH, Klinik für Innere Medizin II</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinikum Regensburg, Abteilung für Hämatologie und internistische Onkologie</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert-Bosch-Krankenhaus, Abt. Hämatologie, Onkologie u. Palliativmedizin</name>
      <address>
        <city>Stuttgart</city>
        <zip>70376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm,Klinik für Innere Medizin III</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinkum Villingen-Schwennigen GmbH</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <zip>78048</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Horst Schmidt Kliniken, Klinik Innere Medizin III</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Wuerzburg, Medizinische Klinik II</name>
      <address>
        <city>Wuerzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiple myeloma</keyword>
  <keyword>autologous stem cell transplant</keyword>
  <keyword>allogeneic stem cell transplant</keyword>
  <keyword>lenalidomide</keyword>
  <keyword>bortezomib</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>Lenalidomide</mesh_term>
    <mesh_term>Bortezomib</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/NCT01685814
org study id: DSMM XIV
secondary id: 2009-016616-21
nct id: NCT01685814
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The investigators propose this study utilizing Lenalidomide, Adriamycin, Dexamethasone (RAD)
      as comparator arm for Lenalidomide, Bortezomib, Dexamethasone (VRD) with the latter being
      considered a novel "standard" as an induction protocol, since response in general occurs
      early after starting treatment we decided to choose three cycles of either induction regimen.

      Together with the "novel compounds", tandem high-dose melphalan is still the standard of
      care; it seems desirable to re-address the question of the number of transplant (single vs.
      double high-dose melphalan) procedures required in the context of triplet-induction protocols
      utilizing at least one of the novel compounds.

      Thus, the question to be asked in the current protocol is whether immediate lenalidomide
      maintenance (i.e. following one cycle of high-dose therapy) as an investigational agent will
      result in identical progression free survival (PFS) when compared to tandem high-dose
      melphalan with deferred maintenance therapy.

      Despite induction with novel compounds, approximately 25 - 40% of patients will be in less
      than very good partial response. Very recently, achievement of less than VGPR was confirmed
      to negatively impact on both PFS as well as overall survival (OS). Therefore, allogeneic stem
      cell transplantation is considered the standard of care in patients with suboptimal response
      to a first autograft.

      In the current protocol, the standard for favourable responders (tandem-autologous
      transplant) is combined with 3 years of lenalidomide maintenance. This approach will be
      investigated for patients with less than VGPR following a first autotransplant and compared
      to the current standard of intensification in poor responders (allogeneic transplantation).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary efficacy endpoint for the induction phase is the rate of patients with CR at first restaging
time frame: within 8 days after end of last induction cycle ((Day 92(RAD); Day 71(VRD))
measure: In the consolidation phase the primary efficacy endpoint for comparison II (response <VGPR after first ASCT) is the PFS rate
time frame: 3 years after the first ASCT, calculated from day 1 of ASCT.
measure: ORR following 3 cycles of induction treatment (VRD vs RAD)
time frame: within 8 days after end of last induction cycle
measure: CR and ORR at the end of the whole treatment programme
time frame: at the end of the whole treatment programme (approx. 8 years)
measure: Overall survival (OS)
time frame: 8 years from study entry
measure: Incidence, severity and relationship of SAEs
time frame: 30 days post last dosing of study drug
measure: Numbers of hospital stays and hospitalization days
time frame: within two years from second restaging
arm group label: single stem cell transplant, 3-year lenalidomide maintenance
arm group type: Active Comparator
description: Arm A
arm group label: tandem autologous transplant, lenalidomide maintenance
arm group type: Experimental
description: Arm B
arm group label: allogeneic stem cell transplant, lenalidomide maintenance
arm group type: Active Comparator
description: Arm C
arm group label: tandem autologous transplant
arm group type: Experimental
description: Arm D
intervention type: Drug
intervention name: Lenalidomide, Bortezomib
description: Induction: two versus one novel drug maintenance: lenalidomide as a maintenance therapy
arm group label: allogeneic stem cell transplant, lenalidomide maintenance
arm group label: single stem cell transplant, 3-year lenalidomide maintenance
arm group label: tandem autologous transplant
arm group label: tandem autologous transplant, lenalidomide maintenance
intervention type: Biological
intervention name: autologous stem cell transplant
arm group label: allogeneic stem cell transplant, lenalidomide maintenance
arm group label: single stem cell transplant, 3-year lenalidomide maintenance
arm group label: tandem autologous transplant
arm group label: tandem autologous transplant, lenalidomide maintenance
intervention type: Biological
intervention name: allogeneic stem cell transplant
arm group label: allogeneic stem cell transplant, lenalidomide maintenance
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Stefan Knop, MD
role: Study Director
affiliation: Wuerzburg University Hospital
last name: Hermann Einsele, MD
role: Principal Investigator
affiliation: Wuerzburg University Hospital
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country: Germany
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Lenalidomide
mesh term: Bortezomib