<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/NCT03001804</url>
  </required_header>
  <id_info>
    <org_study_id>CC-5013-MM-037</org_study_id>
    <nct_id>NCT03001804</nct_id>
  </id_info>
  <brief_title>Use Lenalidomide (Revlimid®) in Combination With Dexamethasone in Clinical Practice for the Treatment of Newly Diagnosed Multiple Myeloma (MM) Transplant Ineligible Patients</brief_title>
  <official_title>Use of Lenalidomide (Revlimid®) in Combination With Dexamethasone in Untreated Non-transplantable Multiple Myeloma in Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this non-interventional study is to collect primarily the percentage of patients&#xD;
      who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15&#xD;
      and 22 of the repetitive 28-day cycles, 20 mg in &gt;75 year old patients) in the registered&#xD;
      indication under practice conditions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple myeloma is still a persistent and life-threatening blood cancer that is&#xD;
      characterised by tumour proliferation and suppression of the immune system. It is a rare but&#xD;
      incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age,&#xD;
      and the majority of newly diagnosed patients may not be eligible for more aggressive&#xD;
      treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015&#xD;
      REVLIMID® (lenalidomide) was approved in combination with dexamethasone for the treatment of&#xD;
      adult patients with previously untreated multiple myeloma who are not eligible for&#xD;
      transplant. Furthermore, in May 2019 REVLIMID® was approved in combination with bortezomib&#xD;
      and dexamethasone for the treatment of adult patients with previously untreated multiple&#xD;
      myeloma who are not eligible for transplant.&#xD;
&#xD;
      Looking in more detail at the combination of lenalidomide and dexamethasone, the role and&#xD;
      especially the most adequate and effective dosage of dexamethasone in long term use with&#xD;
      lenalidomide is not clearly defined or well characterised It is therefore of great relevance&#xD;
      to gain insights into the clinical practice and the routine of dexamethasone management and&#xD;
      dosing in long term use with Revlimid.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Actual">December 16, 2022</completion_date>
  <primary_completion_date type="Actual">December 16, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients receiving dexamethasone after 6 months of treatment</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Deep Venous Thrombosis (VTE) prophylaxis</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Number of patients that receive VTE prophylaxis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Over all response rate (ORR)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Number of patients that achieve a response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events (AEs)</measure>
    <time_frame>up to 2 years</time_frame>
    <description>Number of patients with an adverse events</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">29</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <description>Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr &lt; 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (&gt;75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <description>Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr &lt; 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr &lt; 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (&gt;75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for therapy of untreated multiple myeloma, where stem cell&#xD;
        transplantation cannot be performed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed Informed Consent&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Newly diagnosed Multiple Myeloma&#xD;
&#xD;
          -  Not suitable for stem cell transplantation&#xD;
&#xD;
          -  Appropriate methods of contraception according to the Risk Minimization Program (RMP)&#xD;
&#xD;
          -  Adequate thrombosis prophylaxis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and lactating females&#xD;
&#xD;
          -  No other formal exclusion criteria according to most recent European Summary of&#xD;
             Product Characteristics (SmPC)&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Landeskrankenhaus Kirchdorf</name>
      <address>
        <city>Kirchdorf</city>
        <zip>4560</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Klagenfurt am Wörthersee</name>
      <address>
        <city>Klagenfurt</city>
        <zip>9020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordensklinikum Linz GmbH Elisabethinen</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Schwestern Ried Innere Medizin 1</name>
      <address>
        <city>Ried</city>
        <zip>4910</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Steyr - Innere Medizin</name>
      <address>
        <city>Steyr</city>
        <zip>4400</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Abteilung für Hämatologie und Hämostaseologie</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Josef Krankenhaus</name>
      <address>
        <city>Vienna</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie</name>
      <address>
        <city>Vienna</city>
        <zip>1160</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salzkammergut-Klinikum Vöcklabruck Abteilung Innere Medizin</name>
      <address>
        <city>Vöcklabruck</city>
        <zip>4840</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH, Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH Wiener Neustadt, Innere Medizin</name>
      <address>
        <city>Wr. Neustadt</city>
        <zip>2700</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Revlimid</keyword>
  <keyword>Lenalidomide</keyword>
  <keyword>Non-transplantable</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>
  <!-- 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/NCT03001804
org study id: CC-5013-MM-037
nct id: NCT03001804
lead sponsor: 
has dmc: No
The aim of this non-interventional study is to collect primarily the percentage of patients
      who receive the full dose of dexamethasone (20 or 40 mg orally once daily on days 1, 8, 15
      and 22 of the repetitive 28-day cycles, 20 mg in >75 year old patients) in the registered
      indication under practice conditions.
Multiple myeloma is still a persistent and life-threatening blood cancer that is
      characterised by tumour proliferation and suppression of the immune system. It is a rare but
      incurable disease. On average, multiple myeloma is diagnosed in people 65-74 years of age,
      and the majority of newly diagnosed patients may not be eligible for more aggressive
      treatment options such as high-dose chemotherapy with stem cell transplant. In February 2015
      REVLIMID® (lenalidomide) was approved in combination with dexamethasone for the treatment of
      adult patients with previously untreated multiple myeloma who are not eligible for
      transplant. Furthermore, in May 2019 REVLIMID® was approved in combination with bortezomib
      and dexamethasone for the treatment of adult patients with previously untreated multiple
      myeloma who are not eligible for transplant.

      Looking in more detail at the combination of lenalidomide and dexamethasone, the role and
      especially the most adequate and effective dosage of dexamethasone in long term use with
      lenalidomide is not clearly defined or well characterised It is therefore of great relevance
      to gain insights into the clinical practice and the routine of dexamethasone management and
      dosing in long term use with Revlimid.
observational model: Cohort
time perspective: Prospective
measure: Number of patients receiving dexamethasone after 6 months of treatment
time frame: up to 2 years
description: Number of patients receiving 20mg or 40mg dexamethasone on day 1, 8, 15, 22 of a 28 day cycle after 6 months of treatment
measure: Number of patients with Deep Venous Thrombosis (VTE) prophylaxis
time frame: up to 2 years
description: Number of patients that receive VTE prophylaxis
measure: Over all response rate (ORR)
time frame: up to 2 years
description: Number of patients that achieve a response
measure: Adverse Events (AEs)
time frame: up to 2 years
description: Number of patients with an adverse events
arm group label: Cohort A
description: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
arm group label: Cohort B
description: Initial treatment (up to 8 cycles): Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsule by mouth (PO) on day 1 through 14 of a 21 day cycle, Bortezomib 1.3mg/m2 s.c. on day 1, 4, 8, and 11 of a 21 day cycle, and Dexamethasone 20mg PO on days 1,2,4,5,8,9,11,12 of a 21 day cycle; Successive Treatment: Lenalidomide 25mg or 10mg (reduced renal function 30 ≤ ClCr < 50mg/min) capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell