<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/NCT01718379</url>
  </required_header>
  <id_info>
    <org_study_id>GFM-Len-Epo-08</org_study_id>
    <nct_id>NCT01718379</nct_id>
  </id_info>
  <brief_title>Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.</brief_title>
  <official_title>A Phase II Study Evaluating the Efficacy/Safety of Lenalidomide With or Without Epoetin Beta in Transfusion-dependent ESA-resistant Patients With IPSS Low- and Intermediate-1 Risk Myelodysplastic Syndromes Without Chromosome 5 Abnormality.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Francophone des Myelodysplasies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Groupe Francophone des Myelodysplasies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the present study is to assess, through a randomized phase II trial, the efficacy&#xD;
      and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent,&#xD;
      ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5&#xD;
      abnormality.&#xD;
&#xD;
      Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4&#xD;
      months. Responders will be eligible for maintenance treatment with cycles identical to the&#xD;
      first cycles, until relapse occurs or until unacceptable toxicity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, open-label, randomized, Phase II study.&#xD;
&#xD;
      Patients will be treated either with arm A or B&#xD;
&#xD;
        -  Arm A: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.&#xD;
&#xD;
        -  Arm B: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with&#xD;
           weekly subcutaneous injections of Epoetin beta (60,000 Units/w).&#xD;
&#xD;
      Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.&#xD;
&#xD;
      Maintenance: responders will continue to follow the corresponding treatment arm until relapse&#xD;
      occurs; non responders at Evaluation of response at the end of 4 months according to IWG 2006&#xD;
      and IWG 2000 criteria.&#xD;
&#xD;
      in arm A will be considered in failure of treatment and the introduction of Epoetin beta is&#xD;
      at the discretion of the physician.&#xD;
&#xD;
      The patients will be followed every 3 months for 12 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 2</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>Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant</measure>
    <time_frame>After 4 months of treatment</time_frame>
    <description>Primary outcome is a complete or partial response defined by the IWG 2006 criteria observed after 4 months of treatment. Comparison in the rate of response between the two groups will be performed with Chi-square test or if necessary Fisher exact test.&#xD;
Same analyzes will be performed with the IWG 2000 response definition .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>will be to assess the safety of Lenalidomide and of its combination with Epoetin beta</measure>
    <time_frame>After 2 months of treatment</time_frame>
    <description>Safety of Lenalidomide and of its combination with Epoetin beta: adverse events (type, frequency, severity) and relationship of adverse events to study drug&#xD;
% of major HI-E and minor HI-E after 4 courses according to IWG 2000 criteria&#xD;
Erythroid response duration&#xD;
Time to response&#xD;
Time to progression according to IPSS&#xD;
RBC transfusion independence&#xD;
Prognostic factors of response&#xD;
Survival&#xD;
Quality of life</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.&#xD;
Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.&#xD;
Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.&#xD;
The patients will be followed every 3 months for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w).&#xD;
Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.&#xD;
Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.&#xD;
The patients will be followed every 3 months for 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Lenalidomide:10 mg per day during 21 days</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epoetin beta</intervention_name>
    <description>Epoetin beta: 60,000 Units/week.</description>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>NEORECORMON</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        MDS defined as&#xD;
&#xD;
          -  Low or int-1 IPSS score&#xD;
&#xD;
          -  Documented absence of chromosome 5 abnormality (del(5q) or -5 karyotype)&#xD;
&#xD;
          -  De novo MDS, excluding therapy-related MDS AND&#xD;
&#xD;
          -  Transfusion dependance (requirement of at least 4 units of RBC transfusions every 8&#xD;
             weeks )&#xD;
&#xD;
          -  Resistance or loss of response to a previous treatment with Epoetin alpha/beta (at&#xD;
             least 60,000 Units/w) or Darbepoetin (at least 250 µg/w), for at least 12 weeks&#xD;
&#xD;
          -  Ineligibility for allogeneic stem cell transplantation or intensive chemotherapy&#xD;
             during the next 12 months&#xD;
&#xD;
          -  ECOG performance status ≤ 2&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Life expectancy ≥ 3 months&#xD;
&#xD;
          -  Adequate liver function (transaminases serum levels ≤ 3N)&#xD;
&#xD;
          -  Adequate renal function (calculate creatinine clearance &gt; 50 ml/min)&#xD;
&#xD;
          -  Female subjects of chilbearing potential* must :&#xD;
&#xD;
        Agree to use effective contraception without interruption throughout the study and for at&#xD;
        least 4 weeks after the end of treatment&#xD;
&#xD;
        • Men must: Agree to not conceive during the treatment and to use effective contraception&#xD;
        during the treatment period (including periods of dose reduction or temporary suspension)&#xD;
        and during one week after end of treatment if their partner is of childbearing potential.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active serious infection not controlled by oral or intravenous antibiotics&#xD;
&#xD;
          -  Platelets less than 50 G/L&#xD;
&#xD;
          -  Prior history of deep vein thrombosis or pulmonary embolism&#xD;
&#xD;
          -  Previous treatment by Thalidomide&#xD;
&#xD;
          -  Treatment with any investigational antileukemic agent or chemotherapy at least 6 weeks&#xD;
             prior to study entry and lack of full recovery from side effects due to prior therapy&#xD;
             independent of when that therapy were given&#xD;
&#xD;
          -  Rapidely progressive disease with copromised organ function judged to be&#xD;
             life-threatening by the Investigator&#xD;
&#xD;
          -  Pregnant or lactating female&#xD;
&#xD;
          -  Known human immunodeficiency virus (HIV) infection&#xD;
&#xD;
          -  Known active hepatitis B and/or C virus infection&#xD;
&#xD;
          -  Hypersensitivity or intolerance to Lenalidomide or any of the excipients&#xD;
&#xD;
          -  Hypersensitivity to Epoetin beta or any of the excipients&#xD;
&#xD;
          -  Uncontrolled arterial hypertension&#xD;
&#xD;
          -  Any history of malignancy (other than myelodysplastic syndrome) unless the patient has&#xD;
             remained disease free for more than 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andréa TOMA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Francophone des Myelodysplasies</affiliation>
  </overall_official>
  <overall_official>
    <last_name>François Dreyfus, MD</last_name>
    <role>Study Director</role>
    <affiliation>Groupe Francophone des Myelodysplasies</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hematology Dpt, Service d'Hématologie Clinique</name>
      <address>
        <city>CHU Albert Michallon</city>
        <state>Grenoble</state>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU de Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <state>Ile de France</state>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU Cochin</name>
      <address>
        <city>Paris</city>
        <state>Ile de France</state>
        <zip>75679</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>43033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CH d'Avignon-305 rue Follereau-</name>
      <address>
        <city>Avignon</city>
        <zip>84000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de la Cote Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64 100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>centre de Blois</name>
      <address>
        <city>Blois</city>
        <zip>41016</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU Haut-Lévèque</name>
      <address>
        <city>Bordeaux</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Boulogne Sur Mer</name>
      <address>
        <city>Boulogne Sur Mer</city>
        <zip>62321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>hôpital Morvan</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clémenceau</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Carcassonne</name>
      <address>
        <city>Carcassonne</city>
        <zip>11890</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CH René Dubos</name>
      <address>
        <city>Cergy-pontoise</city>
        <zip>95303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63058</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Compiègne</name>
      <address>
        <city>Compiègne</city>
        <zip>60321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Hôpital Sud Francilien</name>
      <address>
        <city>Corbeil-essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>hopital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <zip>21034</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Hôpital Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt,CH Le mans</name>
      <address>
        <city>Le mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint-Vincent de Paul</name>
      <address>
        <city>Lille</city>
        <zip>59160</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Lyon</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Mantes-la-jolie</name>
      <address>
        <city>Mantes-la-jolie</city>
        <zip>78201</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU Brabois</name>
      <address>
        <city>Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU de nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU Archet</name>
      <address>
        <city>Nice</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU Caremeau</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHR La Source orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>centre René Huguenin</name>
      <address>
        <city>Paris Saint Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Hôpital la pitié-Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Hopital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75475</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Hôpital Maréchal Joffre</name>
      <address>
        <city>Perpignan</city>
        <zip>66046</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Bernard</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, Centre Hospitalier de la région d'Annecy</name>
      <address>
        <city>Pringy cedex</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Saint Quentin</name>
      <address>
        <city>Sint Quentin</city>
        <zip>02321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CHU PURPAN</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Dpt, CH CHU Bretoneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>centre hopitalier princesse Grace</name>
      <address>
        <city>Monaco</city>
        <zip>98012</zip>
        <country>Monaco</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Monaco</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>November 7, 2016</last_update_submitted>
  <last_update_submitted_qc>November 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myelodysplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT01718379
org study id: GFM-Len-Epo-08
nct id: NCT01718379
lead sponsor: 
collaborator: 
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has dmc: No
The goal of the present study is to assess, through a randomized phase II trial, the efficacy
      and safety of Lenalidomide with or without Epoetin beta in transfusion-dependent,
      ESA-resistant, IPSS low and intermediate-1 risk MDS patients without chromosome 5
      abnormality.

      Patients will receive either Lenalidomide alone or Lenalidomide and Epoetin beta for 4
      months. Responders will be eligible for maintenance treatment with cycles identical to the
      first cycles, until relapse occurs or until unacceptable toxicity.
This is a multi-center, open-label, randomized, Phase II study.

      Patients will be treated either with arm A or B

        -  Arm A: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.

        -  Arm B: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with
           weekly subcutaneous injections of Epoetin beta (60,000 Units/w).

      Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.

      Maintenance: responders will continue to follow the corresponding treatment arm until relapse
      occurs; non responders at Evaluation of response at the end of 4 months according to IWG 2006
      and IWG 2000 criteria.

      in arm A will be considered in failure of treatment and the introduction of Epoetin beta is
      at the discretion of the physician.

      The patients will be followed every 3 months for 12 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparing the efficacy of Lenalidomide alone to Lenalidomide with Epoetin beta in transfusion-dependent ESA-resistant
time frame: After 4 months of treatment
description: Primary outcome is a complete or partial response defined by the IWG 2006 criteria observed after 4 months of treatment. Comparison in the rate of response between the two groups will be performed with Chi-square test or if necessary Fisher exact test.
Same analyzes will be performed with the IWG 2000 response definition .
measure: will be to assess the safety of Lenalidomide and of its combination with Epoetin beta
time frame: After 2 months of treatment
description: Safety of Lenalidomide and of its combination with Epoetin beta: adverse events (type, frequency, severity) and relationship of adverse events to study drug
% of major HI-E and minor HI-E after 4 courses according to IWG 2000 criteria
Erythroid response duration
Time to response
Time to progression according to IPSS
RBC transfusion independence
Prognostic factors of response
Survival
Quality of life
arm group label: Arm A
arm group type: Experimental
description: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses.
Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.
Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.
The patients will be followed every 3 months for 12 months
arm group label: Arm B
arm group type: Experimental
description: Lenalidomide 10 mg/day for 21 days every 28 days for 4 courses combined with weekly subcutaneous injections of Epoetin beta (60,000 Units/w).
Evaluation of response at the end of 4 months according to IWG 2006 and IWG 2000 criteria.
Maintenance: responders will continue to follow the corresponding treatment arm until relapse occurs; non responders at cycle 4 in arm A will be considered in failure of treatment and the introduction of Epoetin beta is at the discretion of the physician.
The patients will be followed every 3 months for 12 months
intervention type: Drug
intervention name: Lenalidomide
description: Lenalidomide:10 mg per day during 21 days
arm group label: Arm A
other name: Revlimid
intervention type: Drug
intervention name: Epoetin beta
description: Epoetin beta: 60,000 Units/week.
arm group label: Arm B
other name: NEORECORMON
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andréa TOMA, MD
role: Principal Investigator
affiliation: Groupe Francophone des Myelodysplasies
last name: François Dreyfus, MD
role: Study Director
affiliation: Groupe Francophone des Myelodysplasies
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country: France
country: Monaco
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome
mesh term: Lenalidomide
sharing ipd: No