<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/NCT01686386</url>
  </required_header>
  <id_info>
    <org_study_id>RV-MM-GIMEMA/GISL430</org_study_id>
    <secondary_id>2010-018336-40</secondary_id>
    <nct_id>NCT01686386</nct_id>
  </id_info>
  <brief_title>Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, for the Treatment of Patients With Relapsed Myeloma</brief_title>
  <official_title>A Phase I/II Study of Bendamustine, Lenalidomide and Low-dose Dexamethasone, (BdL) for the Treatment of Patients With Relapsed Myeloma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gruppo Italiano Studio Linfomi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gruppo Italiano Studio Linfomi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open Label, Phase I/II, multicenter study. In the first phase it defines the&#xD;
      maximum tolerated dose (MTD) of Bendamustine (B) given in combination with Lenalidomide (L)&#xD;
      and low-dose Dexamethasone (d) and in the second phase it evaluates the antitumour activity&#xD;
      of Bendamustine, Lenalidomide and Low-dose Dexamethasone (BdL) given in combination, in&#xD;
      relapsed multiple myeloma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple myeloma is a B-cell malignancy resulting from the monoclonal proliferation of plasma&#xD;
      cells within the bone marrow. According to the American Cancer Society, 14,600 new cases of&#xD;
      multiple myeloma will be diagnosed in 2002, and these will account for approximately 1% of&#xD;
      all new cancer cases. Multiple myeloma will contribute to 2% of all cancer deaths this year;&#xD;
      an estimated 10,800 deaths will occur overall. The disease is more prevalent in men and is&#xD;
      twice as common in African-Americans as in Caucasians. Multiple myeloma is commonly thought&#xD;
      of as a disease of older patients; the median age at diagnosis is 68 years, and the incidence&#xD;
      increases more than 4%/year in those older than 85 years. The median survival with standard&#xD;
      treatment is only 3 years.&#xD;
&#xD;
      Therapeutic options for patients with multiple myeloma (MM) are rapidly changing. The&#xD;
      emergence of two highly active novel agents, bortezomib and lenalidomide, have dramatically&#xD;
      changed the landscape of treatment options and have improved outcomes for many patients.&#xD;
      Combinations of conventional agents with novel agents have also demonstrated significant&#xD;
      efficacy for patients with newly diagnosed and relapsed myeloma. Among the conventional&#xD;
      agents that are being explored is the bifunctional alkylator agent bendamustine, which has&#xD;
      demonstrated single-agent activity and activity with novel agents.&#xD;
&#xD;
      Lenalidomide is a new immunomodulating agent effective in multiple myeloma, especially when&#xD;
      associated with dexamethasone or melphalan and prednisone. The role of lenalidomide in the&#xD;
      treatment of relapsed/refractory patients with MM has been established and current research&#xD;
      is focused on the combination of lenalidomide with chemotherapy to further improve results.&#xD;
&#xD;
      Bendamustine is a bi-functional alkylating agent with a purine- like benzimidazole ring that&#xD;
      has been administered successfully to patients with MM. In vitro studies showed that&#xD;
      bendamustine possesses a unique profile of activity, which was clearly divergent from other&#xD;
      common nitrogen mustard drugs. Bendamustine and prednisone in newly diagnosed MM patients&#xD;
      results in superior complete response rate, prolonged time to treatment failure and improved&#xD;
      quality of life compared to treatment with melphalan and prednisone. The role of&#xD;
      bendamustine, thalidomide and prednisolone (BPT) in patients with relapsed or refractory&#xD;
      diseases stage II/III has been investigated by the East German Study group of Hematology and&#xD;
      Oncology (OSHO). The response rate was higher than 80%.&#xD;
&#xD;
      Despite the impressive efficacy of the lenalidomide/dexamethasone in relapsed MM, treated&#xD;
      patients will eventually relapse (median Time to Progression (TTP) is expected to be nearly a&#xD;
      year according the results of the two phase III randomized studies). Combination with an&#xD;
      effective novel agent as bendamustine could further increase both the response rate and the&#xD;
      TTP of lenalidomide/dexamethasone and induce durable responses in relapsed or refractory MM&#xD;
      patients. The identification of an appropriate lenalidomide dose to be adopted in combination&#xD;
      with bendamustine and dexamethasone and the generation of exploratory data on the efficacy of&#xD;
      this novel combination appears to be important in terms of future development of even more&#xD;
      effective treatments of MM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2010</start_date>
  <completion_date type="Anticipated">October 2013</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>Phase 1/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>Phase I:Determination of Maximum Tolerated Dose</measure>
    <time_frame>up to 28 days during first cycle</time_frame>
    <description>In the first phase of the study, the dose of Bendamustine and Lenalidomide given with will be gradually escalated to reach the Maximum Tolerated Dose. The Maximum Tolerated Dose of Bendamustine and Lenalidomide will be evaluated during the first course (cycle 1) of Bendamustine Dexamethasone Lenalidomide (BdL) administered</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase I:Determination of occurrence rate of AE/SAEs</measure>
    <time_frame>up to 28 day (during the first cycle 1of BdL administered)</time_frame>
    <description>To assess the Safety and Toxicity of the Bendamustine,Dexamethasone and Lenalidomide (BdL) regimen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase II: Overall Response Rate (ORR)</measure>
    <time_frame>An avarage of 6 months (after 6 cycles of therapy)</time_frame>
    <description>To assess the antitumour activity of the BdL regimen, in term of Complete response, Partial response and Stable disease, according to the best schedule identified during Phase I.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase I: Assessment of the preliminary antineoplastic properties of the BdL</measure>
    <time_frame>after an avarage of 6 months</time_frame>
    <description>To explore the preliminary antitumor activity of drug combination in patients with relapsed MM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II: AE/SAEs</measure>
    <time_frame>Every 28 days (during all cycles)</time_frame>
    <description>To define the safety profile of the treatment assessing the occurrence rate and the severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II:Determination of the response rates</measure>
    <time_frame>Assessed after 6 months</time_frame>
    <description>To assess Partial Response and Complete Response rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase II:Time to Event parameters</measure>
    <time_frame>avarage 6 months</time_frame>
    <description>To evaluate the efficacy of the BdL regimen in patients with relapsed MM, in terms of Progression-Free Survival, Time to Progression, Time to Response, Duration of Response ,Overall Survival(PFS, TTP, TTR, DR, OS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Dose escalation benda lena dexa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I: Participants will be treated in groups (cohorts) of three to six subjects per cohort, according to a modified Fibonacci design. The dose of Bendamustine and Lenalidomide (from 0 to 5) will be increased from one cohort to the next. Regardless of the treatment cohort, participants will receive treatment in cycles lasting 28 days. In the first phase of the study, the dose of B and L given with will be gradually escalated to reach the MTD.&#xD;
Phase II: Dexamethasone will be given in combination with the MTD of Bendamustine and Lenalidomide in cycles lasting 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Phase I: dose escalation of Bendamustine Phase II: Dexamethasone will be given in combination with the MTD of Bendamustine and Lenalidomide in cycles lasting 28 days.</description>
    <arm_group_label>Dose escalation benda lena dexa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Phase I: dose escalation of Lenalidomide Phase II: Dexamethasone will be given in combination with the Maximum Tolerated Dose (MTD) of Bendamustine and Lenalidomide in cycles lasting 28 days.</description>
    <arm_group_label>Dose escalation benda lena dexa</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Phase I and Phase II Dexamethasone fixed dose 40 mg/die</description>
    <arm_group_label>Dose escalation benda lena dexa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntary written informed consent&#xD;
&#xD;
          -  Men and women age ≥ 18 years&#xD;
&#xD;
          -  Female subjects are either post-menopausal or surgically sterilized or willing to use&#xD;
             2 simultaneous methods of contraception&#xD;
&#xD;
          -  Male patients must agree to use a latex condom during sexual contact with females of&#xD;
             childbearing potential throughout the study and for at least 28 days following&#xD;
             discontinuation of lenalidomide;&#xD;
&#xD;
          -  Confirmed diagnosis of Multiple Myeloma with measurable disease .Patients with&#xD;
             evidence of relapsed disease after more than 1 and equal but not more than 3 prior&#xD;
             lines of therapy.&#xD;
&#xD;
          -  ECOG Performance Status 0 - 2&#xD;
&#xD;
          -  Required baseline haematology and chemistry parameters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Myocardial infarction within 6 months prior to enrollment or has NYHA class III or IV&#xD;
             heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or&#xD;
             electrocardiographic evidence of acute ischemia or active conduction system&#xD;
             abnormalities.&#xD;
&#xD;
          -  Female subjects either pregnant or breast-feeding (negative serum β-human chorionic&#xD;
             gonadotropin (β-hCG) pregnancy test result)&#xD;
&#xD;
          -  Patients have received other investigational drugs with 14 days before enrollment.&#xD;
&#xD;
          -  Serious medical or psychiatric illness likely to interfere with participation in this&#xD;
             clinical study.&#xD;
&#xD;
          -  Any of the following laboratory abnormalities:&#xD;
&#xD;
        Absolute neutrophil count (ANC) &lt;1,000 /μl (1x109 /L) Untransfused platelet count &lt;&#xD;
        50,0000cell/μl (50x109 /L) Serum SGOT/AST or SGPT/ALT &gt; 2.0 upper limit of normal (ULN)&#xD;
        Total bilirubin &gt; 2.0 mg/dL Renal insufficiently (serum creatinine level &gt; 2.5 mg/dl or&#xD;
        Creatinine clearance &lt; 30 mL/min calculated by Cockcroft-Gault estimation)&#xD;
&#xD;
          -  Patients with active infections are ineligible.&#xD;
&#xD;
          -  Patients who are HIV positive are ineligible.&#xD;
&#xD;
          -  Patients with active leptomeningeal involvement are ineligible.&#xD;
&#xD;
          -  Patients with a history of previous CSF tumor involvement without symptoms or signs&#xD;
             are eligible provided the CSF is now free of disease on lumbar puncture, and MRI of&#xD;
             the brain shows no tumor involvement.&#xD;
&#xD;
          -  History of other malignancies within 3 years prior to study entry except for&#xD;
             adequately treated carcinoma in situ of the cervix or basal or squamous cell skin&#xD;
             cancer or breast, low grade, early stage localized prostate cancer treated surgically&#xD;
             with curative intent (TNM stage of T1a or T1b),&#xD;
&#xD;
          -  Patients with uncontrolled insulin-dependent diabetes mellitus or uncompensated major&#xD;
             thyroid or adrenal dysfunction are ineligible.&#xD;
&#xD;
          -  Patients with an ECOG performance status of &gt; 2 are ineligible.&#xD;
&#xD;
          -  Malabsorption syndrome or uncontrolled gastrointestinal toxicities&#xD;
&#xD;
          -  Clinically significant pleural effusion in the previous 12 months or current ascitis&#xD;
&#xD;
          -  Clinically-significant coagulation or platelet function disorder&#xD;
&#xD;
          -  Intolerance to bendamustine and/or lenalidomide&#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>Fortunato Morabito, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Unità Operativa Complessa di Ematologia- Stabilimento Ospedaliero Annunziata - Azienda Ospedaliera di Cosenza</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fortunato Morabito, MD</last_name>
    <phone>+390984681329</phone>
    <email>fortunato_morabito@tin.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fortunato Morabito, MD</last_name>
    <phone>+390984681539</phone>
    <email>fortunato_morabito@tin.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>U. O. C. Ematologia - Azienda Ospedaliera Cosenza</name>
      <address>
        <city>Cosenza</city>
        <zip>87100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fortunato Morabito, MD</last_name>
      <phone>+390984681329</phone>
      <email>fortunato_morabito@tin.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20. Erratum In: Leukemia. 2006 Dec;20(12):2220. Leukemia. 2007 May;21(5):1134.</citation>
    <PMID>16855634</PMID>
  </reference>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>April 4, 2013</last_update_submitted>
  <last_update_submitted_qc>April 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsed</keyword>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Lenalidomide</keyword>
  <keyword>Bendamustine</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/NCT01686386
org study id: RV-MM-GIMEMA/GISL430
secondary id: 2010-018336-40
nct id: NCT01686386
lead sponsor: 
has dmc: No
This is an open Label, Phase I/II, multicenter study. In the first phase it defines the
      maximum tolerated dose (MTD) of Bendamustine (B) given in combination with Lenalidomide (L)
      and low-dose Dexamethasone (d) and in the second phase it evaluates the antitumour activity
      of Bendamustine, Lenalidomide and Low-dose Dexamethasone (BdL) given in combination, in
      relapsed multiple myeloma patients.
Multiple myeloma is a B-cell malignancy resulting from the monoclonal proliferation of plasma
      cells within the bone marrow. According to the American Cancer Society, 14,600 new cases of
      multiple myeloma will be diagnosed in 2002, and these will account for approximately 1% of
      all new cancer cases. Multiple myeloma will contribute to 2% of all cancer deaths this year;
      an estimated 10,800 deaths will occur overall. The disease is more prevalent in men and is
      twice as common in African-Americans as in Caucasians. Multiple myeloma is commonly thought
      of as a disease of older patients; the median age at diagnosis is 68 years, and the incidence
      increases more than 4%/year in those older than 85 years. The median survival with standard
      treatment is only 3 years.

      Therapeutic options for patients with multiple myeloma (MM) are rapidly changing. The
      emergence of two highly active novel agents, bortezomib and lenalidomide, have dramatically
      changed the landscape of treatment options and have improved outcomes for many patients.
      Combinations of conventional agents with novel agents have also demonstrated significant
      efficacy for patients with newly diagnosed and relapsed myeloma. Among the conventional
      agents that are being explored is the bifunctional alkylator agent bendamustine, which has
      demonstrated single-agent activity and activity with novel agents.

      Lenalidomide is a new immunomodulating agent effective in multiple myeloma, especially when
      associated with dexamethasone or melphalan and prednisone. The role of lenalidomide in the
      treatment of relapsed/refractory patients with MM has been established and current research
      is focused on the combination of lenalidomide with chemotherapy to further improve results.

      Bendamustine is a bi-functional alkylating agent with a purine- like benzimidazole ring that
      has been administered successfully to patients with MM. In vitro studies showed that
      bendamustine possesses a unique profile of activity, which was clearly divergent from other
      common nitrogen mustard drugs. Bendamustine and prednisone in newly diagnosed MM patients
      results in superior complete response rate, prolonged time to treatment failure and improved
      quality of life compared to treatment with melphalan and prednisone. The role of
      bendamustine, thalidomide and prednisolone (BPT) in patients with relapsed or refractory
      diseases stage II/III has been investigated by the East German Study group of Hematology and
      Oncology (OSHO). The response rate was higher than 80%.

      Despite the impressive efficacy of the lenalidomide/dexamethasone in relapsed MM, treated
      patients will eventually relapse (median Time to Progression (TTP) is expected to be nearly a
      year according the results of the two phase III randomized studies). Combination with an
      effective novel agent as bendamustine could further increase both the response rate and the
      TTP of lenalidomide/dexamethasone and induce durable responses in relapsed or refractory MM
      patients. The identification of an appropriate lenalidomide dose to be adopted in combination
      with bendamustine and dexamethasone and the generation of exploratory data on the efficacy of
      this novel combination appears to be important in terms of future development of even more
      effective treatments of MM.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase I:Determination of Maximum Tolerated Dose
time frame: up to 28 days during first cycle
description: In the first phase of the study, the dose of Bendamustine and Lenalidomide given with will be gradually escalated to reach the Maximum Tolerated Dose. The Maximum Tolerated Dose of Bendamustine and Lenalidomide will be evaluated during the first course (cycle 1) of Bendamustine Dexamethasone Lenalidomide (BdL) administered
measure: Phase I:Determination of occurrence rate of AE/SAEs
time frame: up to 28 day (during the first cycle 1of BdL administered)
description: To assess the Safety and Toxicity of the Bendamustine,Dexamethasone and Lenalidomide (BdL) regimen
measure: Phase II: Overall Response Rate (ORR)
time frame: An avarage of 6 months (after 6 cycles of therapy)
description: To assess the antitumour activity of the BdL regimen, in term of Complete response, Partial response and Stable disease, according to the best schedule identified during Phase I.
measure: Phase I: Assessment of the preliminary antineoplastic properties of the BdL
time frame: after an avarage of 6 months
description: To explore the preliminary antitumor activity of drug combination in patients with relapsed MM
measure: Phase II: AE/SAEs
time frame: Every 28 days (during all cycles)
description: To define the safety profile of the treatment assessing the occurrence rate and the severity
measure: Phase II:Determination of the response rates
time frame: Assessed after 6 months
description: To assess Partial Response and Complete Response rates
measure: Phase II:Time to Event parameters
time frame: avarage 6 months
description: To evaluate the efficacy of the BdL regimen in patients with relapsed MM, in terms of Progression-Free Survival, Time to Progression, Time to Response, Duration of Response ,Overall Survival(PFS, TTP, TTR, DR, OS)
arm group label: Dose escalation benda lena dexa
arm group type: Experimental
description: Phase I: Participants will be treated in groups (cohorts) of three to six subjects per cohort, according to a modified Fibonacci design. The dose of Bendamustine and Lenalidomide (from 0 to 5) will be increased from one cohort to the next. Regardless of the treatment cohort, participants will receive treatment in cycles lasting 28 days. In the first phase of the study, the dose of B and L given with will be gradually escalated to reach the MTD.
Phase II: Dexamethasone will be given in combination with the MTD of Bendamustine and Lenalidomide in cycles lasting 28 days.
intervention type: Drug
intervention name: Bendamustine
description: Phase I: dose escalation of Bendamustine Phase II: Dexamethasone will be given in combination with the MTD of Bendamustine and Lenalidomide in cycles lasting 28 days.
arm group label: Dose escalation benda lena dexa
intervention type: Drug
intervention name: Lenalidomide
description: Phase I: dose escalation of Lenalidomide Phase II: Dexamethasone will be given in combination with the Maximum Tolerated Dose (MTD) of Bendamustine and Lenalidomide in cycles lasting 28 days.
arm group label: Dose escalation benda lena dexa
intervention type: Drug
intervention name: Dexamethasone
description: Phase I and Phase II Dexamethasone fixed dose 40 mg/die
arm group label: Dose escalation benda lena dexa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fortunato Morabito, MD
role: Study Chair
affiliation: Unità Operativa Complessa di Ematologia- Stabilimento Ospedaliero Annunziata - Azienda Ospedaliera di Cosenza
last name: Fortunato Morabito, MD
phone: +390984681329
email: fortunato_morabito@tin.it
last name: Fortunato Morabito, MD
phone: +390984681539
email: fortunato_morabito@tin.it
facility: 
status: Recruiting
contact: 
country: Italy
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PMID: 16855634
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Lenalidomide
mesh term: Bendamustine Hydrochloride