<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/NCT01701076</url>
  </required_header>
  <id_info>
    <org_study_id>CTU10.041/BRd</org_study_id>
    <secondary_id>2010-022253-42</secondary_id>
    <nct_id>NCT01701076</nct_id>
  </id_info>
  <brief_title>Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma</brief_title>
  <acronym>BRd</acronym>
  <official_title>An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cantonal Hospital of St. Gallen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mundipharma Research GmbH &amp; Co KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mundipharma Medical Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Cantonal Hospital of St. Gallen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Almost all patients with multiple myeloma who survive initial treatment will eventually&#xD;
      relapse and require further therapy.&#xD;
&#xD;
      Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large&#xD;
      randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months&#xD;
      for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior&#xD;
      therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone until&#xD;
      disease progression is therefore considered a standard therapy for second line treatment in&#xD;
      multiple myeloma patients. However, only a relatively low rate of high quality response (CR,&#xD;
      complete response and VGPR, very good partial response) is achieved. High quality responses&#xD;
      are associated with with improved progression-free survival and overall survival [4].&#xD;
&#xD;
      Trial: The aim of this trial is to improve high quality response rates for patients with&#xD;
      relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved&#xD;
      by the addition a third anti-myeloma drug (bendamustine) to the established backbone of&#xD;
      lenalidomide/ dexamethasone.&#xD;
&#xD;
      Treatment regimen:&#xD;
&#xD;
        -  Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide&#xD;
           25mg/d 1-21, dexamethasone 40mg / 20mg (for patients &gt; 75years) d 1, 8, 15, 22.&#xD;
&#xD;
        -  Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg /&#xD;
           20mg (for patients &gt; 75 years) d 1, 8, 15, 22.&#xD;
&#xD;
      Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is&#xD;
      mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe&#xD;
      neutropenia.&#xD;
&#xD;
      The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this&#xD;
      aim is achieved, the treatment of bendamustine in combination with the established&#xD;
      lenalidomide/ dexamethasone regimen will be considered promising.&#xD;
&#xD;
      Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessments for efficacy / response evaluation:&#xD;
&#xD;
        -  M-protein quantitation in serum and 24 h urine collection samples by serum- and urine&#xD;
           protein electrophoresis&#xD;
&#xD;
        -  Quantitation of immunoglobulin levels by nephelometry&#xD;
&#xD;
        -  Serum and urine immunofixation&#xD;
&#xD;
        -  Free light chain concentrations and ratio in the serum&#xD;
&#xD;
        -  Plasma cell percentage in the bone marrow by conventional cytology and biopsy with&#xD;
           immunohistochemistry&#xD;
&#xD;
        -  Radiologic assessments of the skeleton&#xD;
&#xD;
      Response criteria: Response will be assessed according to IMWG criteria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy (combined CR-/VGPR-rate) achieved during the induction treatment phase or within four weeks after the last administration of six induction cycles of the BRd regimen</measure>
    <time_frame>Every 4 weeks up to 7 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rates (sCR, CR, VGPR, PR, MR)</measure>
    <time_frame>Every 4 weeks up to 7 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best response (sCR, CR, VGPR, PR, MR)</measure>
    <time_frame>Every 4 weeks up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP)</measure>
    <time_frame>Every 4 weeks up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Every 8 weeks up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>Every 4 weeks until 30 days after completion of study treatment</time_frame>
    <description>Type, frequency, severity, and relationship of adverse events to study therapy&#xD;
According to NCI CTCAE v4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Bendamustine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients are treated with bendamustine in combination with lenalidomide and dexamethasone for a maximum of 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Induction treatment phase (cycle 1-6):&#xD;
Bendamustine 75 mg/m2 i.v day 1 and 2&#xD;
Lenalidomide 25 mg p.o. day 1-21&#xD;
Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22&#xD;
Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia&#xD;
Maintenance treatment phase (cycles 7-18):&#xD;
Lenalidomide 25 mg p.o. day 1-21&#xD;
Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22</description>
    <arm_group_label>Bendamustine</arm_group_label>
    <other_name>Lenalidomide</other_name>
    <other_name>Dexamethasone</other_name>
    <other_name>Pegfilgrastim</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Patients with first relapsed or refractory multiple myeloma (including patients with&#xD;
             relapse after high dose chemotherapy followed by autologous stem cell transplantation)&#xD;
             who have received no more than one prior line of anti-myeloma treatment&#xD;
&#xD;
          -  Treatment with a lenalidomide/ dexamethasone-based 2nd-line regimen is indicated and&#xD;
             intended&#xD;
&#xD;
          -  Measurable disease as defined by at least one of the following 3 measurements&#xD;
&#xD;
               -  serum monoclonal protein level ≥ 1 g/dl (≥ 10 g/l) or&#xD;
&#xD;
               -  urine M-protein level ≥ 200 mg/24hours or&#xD;
&#xD;
               -  serum FLC assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) provided serum FLC&#xD;
                  ratio is abnormal&#xD;
&#xD;
          -  ECOG performance status 0, 1, or 2&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  All previous cancer therapy (except corticosteroid therapy), including radiation,&#xD;
             cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to&#xD;
             treatment in this study.&#xD;
&#xD;
          -  No prior treatment with a bendamustine-containing regimen allowed&#xD;
&#xD;
          -  Prior treatment with lenalidomide is allowed if the treatment is completed &gt; 12 month&#xD;
             prior to study entry and the patient responded to prior lenalidomide treatment&#xD;
&#xD;
          -  Adequate hematological values:&#xD;
&#xD;
               -  absolute neutrophil count ≥ 1.5 x 109/L&#xD;
&#xD;
               -  platelets ≥ 100 x 109/L&#xD;
&#xD;
               -  hemoglobin &gt; 80 g/L, unless considered to be caused by the underlying hematologic&#xD;
                  malignancy, based on the investigator's clinical judgement&#xD;
&#xD;
          -  Adequate hepatic function:&#xD;
&#xD;
               -  total bilirubin &lt; 1.2 mg/dL&#xD;
&#xD;
               -  AST (SGOT) ≤ 2.5 x ULN&#xD;
&#xD;
          -  Adequate renal function:&#xD;
&#xD;
             o calculated creatinine clearance &gt; 50 ml/min, according to the formula of&#xD;
             Cockcroft-Gault&#xD;
&#xD;
          -  Disease free of prior malignancies for &gt; 5 years unless the patient&#xD;
&#xD;
               -  has been treated with a curative intent and is considered to be in complete&#xD;
                  remission for ≥2 years prior to study enrolment&#xD;
&#xD;
               -  or has a curatively-treated&#xD;
&#xD;
                    -  basal cell/ squamous cell carcinoma of the skin,&#xD;
&#xD;
                    -  carcinoma &quot;in situ&quot;of the cervix,&#xD;
&#xD;
                    -  ductal breast carcinoma in situ with complete surgical resection (i.e.&#xD;
                       negative margins),&#xD;
&#xD;
                    -  medullary or papillary thyroid tumor&#xD;
&#xD;
                    -  or low grade, early stage localized prostate cancer treated surgically with&#xD;
                       curative intent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast feeding females&#xD;
&#xD;
          -  Any prior use of bendamustine&#xD;
&#xD;
          -  Patients who are unable or unwillingly to undergo antithrombotic therapy&#xD;
&#xD;
          -  Any serious underlying medical condition (at the judgment of the investigator) which&#xD;
             impairs the ability of the patient to participate in the trial (e.g. active autoimmune&#xD;
             disease, uncontrolled diabetes, ongoing or active infection, symptomatic congestive&#xD;
             heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric disorder)&#xD;
&#xD;
          -  Any condition, including the presence of laboratory abnormalities, which places the&#xD;
             subject at unacceptable risk if he/she would participate in the study or any condition&#xD;
             significantly confounding the ability to interpret data from the study, based on the&#xD;
             local investigator's judgement&#xD;
&#xD;
          -  Severe cardiovascular disease, including myocardial infarction within 6 months before&#xD;
             study entry, New York Heart Association Class III or IV heart failure, uncontrolled&#xD;
             angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3)&#xD;
&#xD;
          -  Use of any other experimental drug or therapy/ treatment in a clinical trial within 30&#xD;
             days prior to trial entry&#xD;
&#xD;
          -  Known hypersensitivity to study drug(s) or hypersensitivity to any other component of&#xD;
             the study drugs&#xD;
&#xD;
          -  Any concurrent antineoplastic therapy with chemotherapeutic agents or biologic agents&#xD;
             or radiation therapy&#xD;
&#xD;
          -  Any major surgical procedure within 30 days prior to study therapy&#xD;
&#xD;
          -  Known chronic hepatitis B or C, known HIV infection&#xD;
&#xD;
          -  Jaundice or any other severe damage of the liver parenchyma&#xD;
&#xD;
          -  Any contraindication for the treatment with bendamustine, lenalidomide, dexamethasone&#xD;
             and / or pegfilgrastim in accordance with the appropriate SmPCs&#xD;
&#xD;
          -  Any other concomitant drugs contraindicated for use with the study drugs according to&#xD;
             the national health authorities&#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>Ulrich Mey, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Kantonsspital Graubünden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen</name>
      <address>
        <city>St. Gallen</city>
        <zip>9000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.</citation>
    <PMID>18032763</PMID>
  </reference>
  <reference>
    <citation>Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.</citation>
    <PMID>18032762</PMID>
  </reference>
  <reference>
    <citation>Dimopoulos MA, Chen C, Spencer A, Niesvizky R, Attal M, Stadtmauer EA, Petrucci MT, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Leukemia. 2009 Nov;23(11):2147-52. doi: 10.1038/leu.2009.147. Epub 2009 Jul 23.</citation>
    <PMID>19626046</PMID>
  </reference>
  <reference>
    <citation>Harousseau JL, Attal M, Avet-Loiseau H. The role of complete response in multiple myeloma. Blood. 2009 Oct 8;114(15):3139-46. doi: 10.1182/blood-2009-03-201053. Epub 2009 Jul 28.</citation>
    <PMID>19638622</PMID>
  </reference>
  <reference>
    <citation>Lentzsch S, O'Sullivan A, Kennedy RC, Abbas M, Dai L, Pregja SL, Burt S, Boyiadzis M, Roodman GD, Mapara MY, Agha M, Waas J, Shuai Y, Normolle D, Zonder JA. Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study. Blood. 2012 May 17;119(20):4608-13. doi: 10.1182/blood-2011-12-395715. Epub 2012 Mar 26.</citation>
    <PMID>22451423</PMID>
  </reference>
  <reference>
    <citation>Pönisch W, Heyn S, Wagner I, et al. Combined Bendamustine, Prednisolone and Lenalidomide (RBP) In Refractory or Relapsed Multiple Myeloma. First Results of a Phase I Clinical Trial. Blood, Nov 2010; 116: 1971</citation>
  </reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>August 23, 2016</last_update_submitted>
  <last_update_submitted_qc>August 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Graubünden</investigator_affiliation>
    <investigator_full_name>PD Dr. Ulrich Mey</investigator_full_name>
    <investigator_title>PD Dr.med.</investigator_title>
  </responsible_party>
  <keyword>Relapsed / refractory multiple myeloma</keyword>
  <keyword>2nd line treatment</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>Dexamethasone</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</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/NCT01701076
org study id: CTU10.041/BRd
secondary id: 2010-022253-42
nct id: NCT01701076
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Almost all patients with multiple myeloma who survive initial treatment will eventually
      relapse and require further therapy.

      Background: Treatment with lenalidomide and dexamethasone has proven efficacy in two large
      randomized trials (MM-009 and MM-010) leading to a time to progression (TTP) of 17.1 months
      for patients with only one prior therapy and a TTP of 10.6 months for 2 and more prior
      therapies, respectively [1-3]. Continuous treatment with lenalidomide and dexamethasone until
      disease progression is therefore considered a standard therapy for second line treatment in
      multiple myeloma patients. However, only a relatively low rate of high quality response (CR,
      complete response and VGPR, very good partial response) is achieved. High quality responses
      are associated with with improved progression-free survival and overall survival [4].

      Trial: The aim of this trial is to improve high quality response rates for patients with
      relapsed or refractory multiple myeloma in the 2nd line treatment. This aim shall be achieved
      by the addition a third anti-myeloma drug (bendamustine) to the established backbone of
      lenalidomide/ dexamethasone.

      Treatment regimen:

        -  Induction Treatment Phase: Cycles 1-6 Bendamustine 75mg/m2/d day 1 and 2, lenalidomide
           25mg/d 1-21, dexamethasone 40mg / 20mg (for patients > 75years) d 1, 8, 15, 22.

        -  Maintenance Treatment Phase: Cycles 7-18 lenalidomide 25mg/d 1-21, dexamethasone 40mg /
           20mg (for patients > 75 years) d 1, 8, 15, 22.

      Due to hematoxicity of bendamustine and lenalidomide, administration of pegfilgrastim is
      mandatory in the induction treatment phase (BRd-regimen)for all patients experiencing severe
      neutropenia.

      The aim of this study is to achieve high quality response rates (CR, VGPR) of ≥ 40%. If this
      aim is achieved, the treatment of bendamustine in combination with the established
      lenalidomide/ dexamethasone regimen will be considered promising.

      Besides efficacy, the safety of this three-drug regimen is evaluated in this trial.
Assessments for efficacy / response evaluation:

        -  M-protein quantitation in serum and 24 h urine collection samples by serum- and urine
           protein electrophoresis

        -  Quantitation of immunoglobulin levels by nephelometry

        -  Serum and urine immunofixation

        -  Free light chain concentrations and ratio in the serum

        -  Plasma cell percentage in the bone marrow by conventional cytology and biopsy with
           immunohistochemistry

        -  Radiologic assessments of the skeleton

      Response criteria: Response will be assessed according to IMWG criteria
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy (combined CR-/VGPR-rate) achieved during the induction treatment phase or within four weeks after the last administration of six induction cycles of the BRd regimen
time frame: Every 4 weeks up to 7 months
measure: Objective response rates (sCR, CR, VGPR, PR, MR)
time frame: Every 4 weeks up to 7 months
measure: Best response (sCR, CR, VGPR, PR, MR)
time frame: Every 4 weeks up to 36 months
measure: Time to progression (TTP)
time frame: Every 4 weeks up to 36 months
measure: Overall survival (OS)
time frame: Every 8 weeks up to 36 months
measure: Safety and tolerability
time frame: Every 4 weeks until 30 days after completion of study treatment
description: Type, frequency, severity, and relationship of adverse events to study therapy
According to NCI CTCAE v4.0
arm group label: Bendamustine
arm group type: Experimental
description: All patients are treated with bendamustine in combination with lenalidomide and dexamethasone for a maximum of 6 cycles.
intervention type: Drug
intervention name: Bendamustine
description: Induction treatment phase (cycle 1-6):
Bendamustine 75 mg/m2 i.v day 1 and 2
Lenalidomide 25 mg p.o. day 1-21
Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22
Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia
Maintenance treatment phase (cycles 7-18):
Lenalidomide 25 mg p.o. day 1-21
Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22
arm group label: Bendamustine
other name: Lenalidomide
other name: Dexamethasone
other name: Pegfilgrastim
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrich Mey, MD
role: Study Chair
affiliation: Kantonsspital Graubünden
facility: 
country: Switzerland
citation: Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.
PMID: 18032763
citation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.
PMID: 18032762
citation: Dimopoulos MA, Chen C, Spencer A, Niesvizky R, Attal M, Stadtmauer EA, Petrucci MT, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Long-term follow-up on overall survival from the MM-009 and MM-010 phase III trials of lenalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Leukemia. 2009 Nov;23(11):2147-52. doi: 10.1038/leu.2009.147. Epub 2009 Jul 23.
PMID: 19626046
citation: Harousseau JL, Attal M, Avet-Loiseau H. The role of complete response in multiple myeloma. Blood. 2009 Oct 8;114(15):3139-46. doi: 10.1182/blood-2009-03-201053. Epub 2009 Jul 28.
PMID: 19638622
citation: Lentzsch S, O'Sullivan A, Kennedy RC, Abbas M, Dai L, Pregja SL, Burt S, Boyiadzis M, Roodman GD, Mapara MY, Agha M, Waas J, Shuai Y, Normolle D, Zonder JA. Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase 1/2 open-label, dose escalation study. Blood. 2012 May 17;119(20):4608-13. doi: 10.1182/blood-2011-12-395715. Epub 2012 Mar 26.
PMID: 22451423
citation: Pönisch W, Heyn S, Wagner I, et al. Combined Bendamustine, Prednisolone and Lenalidomide (RBP) In Refractory or Relapsed Multiple Myeloma. First Results of a Phase I Clinical Trial. Blood, Nov 2010; 116: 1971
responsible party type: Principal Investigator
investigator affiliation: Kantonsspital Graubünden
investigator full name: PD Dr. Ulrich Mey
investigator title: PD Dr.med.
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Lenalidomide
mesh term: Bendamustine Hydrochloride