<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/NCT02237261</url>
  </required_header>
  <id_info>
    <org_study_id>BPV</org_study_id>
    <secondary_id>2013-005485-19</secondary_id>
    <nct_id>NCT02237261</nct_id>
  </id_info>
  <brief_title>Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma</brief_title>
  <acronym>BPV</acronym>
  <official_title>Bendamustine, Prednisone and Velcade® for First-line Treatment of Patients With Symptomatic Multiple Myeloma Not Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplantation (BPV).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Heidelberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Cancer Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Janssen-Cilag International NV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mundipharma Research GmbH &amp; Co KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>inVentiv Health Clinical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Heidelberg</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to improve efficacy of treatment for patients with newly&#xD;
      diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by&#xD;
      autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Objectives Primary&#xD;
&#xD;
           -Therapeutic efficacy of BPV regimen for multiple myeloma as evidenced by the overall&#xD;
           response defined as partial response (PR) or better&#xD;
&#xD;
           Secondary&#xD;
&#xD;
             -  to assess overall survival (OS) and progression-free survival (PFS)&#xD;
&#xD;
             -  to determine response duration&#xD;
&#xD;
             -  to investigate improvements of renal function&#xD;
&#xD;
             -  to evaluate safety and toxicity (with respect to adverse events of CTCAE grade ≧3&#xD;
                and SAEs)&#xD;
&#xD;
             -  to analyze the efficacy for genetically defined subgroups of myeloma patients based&#xD;
                on iFISH and gene-expression profiling&#xD;
&#xD;
        2. Investigational Medicinal Products Bortezomib Bendamustine both in combination with&#xD;
           Prednisone&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Overall Response Rate (ORR) of BPV</measure>
    <time_frame>2 years</time_frame>
    <description>ORR is defined as PR or better</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and percentage of patients achieving a complete response</measure>
    <time_frame>2 years</time_frame>
    <description>Number and percentage of patients achieving a complete response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>PFS defined as time from registration to progression or death whatever comes first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>2 years</time_frame>
    <description>OS defined as time from registration to time of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-to-progression (TTP)</measure>
    <time_frame>2 years</time_frame>
    <description>TTP defined as time from registration to disease progression. TTP is censored at time of deaths which are not caused by progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS)</measure>
    <time_frame>2 years</time_frame>
    <description>DFS defined as time from start of CR to relapse or death from any cause whichever comes first. Patients evaluable for DFS are patients in complete Response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>2 years</time_frame>
    <description>DOR defined as time from first observation of PR to the time of disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal response according to IMWG (CRrenal, PRrenal, MRrenal)</measure>
    <time_frame>2 years</time_frame>
    <description>percent of patients with recovery/improvement of renal function (for patients with impared renal finction at baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)</measure>
    <time_frame>2 years</time_frame>
    <description>toxicity during study therapy with AE of CTC grade ≧ 3, as well as neuropathy of CTC grade 2, measured by CTC-AE (v4.0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to objective Response (TOR)</measure>
    <time_frame>2 years</time_frame>
    <description>TOR defined as time from registration to achieving an objective response for patients achieving an objective Response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to treatment failure (TTF)</measure>
    <time_frame>2 years</time_frame>
    <description>TTF is defined as time from registration to treatment discontinuation for any reason, including disease progression, Treatment toxicity, patient preference or death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Bendamustine, Bortezomib, Prednisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction: Bortezomib: 1.3 mg/m2 subcutaneous for 7 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison: : 60 mg/m2 per os for 4 days Consolidation: Bortezomib: 1.3 mg/m2 subcutaneous for 4 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison 60 mg/m2 per os for 4 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine, Bortezomib, Prednisone</intervention_name>
    <description>Cycle 1 (d1-42) - Induction:&#xD;
Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4&#xD;
Cycle 2-9 (d1-28) - Consolidation:&#xD;
Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4</description>
    <arm_group_label>Bendamustine, Bortezomib, Prednisone</arm_group_label>
    <other_name>Velcade (Bortezomib)</other_name>
    <other_name>Levact (Bendamustine)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed multiple myeloma requiring systemic treatment (according to CRAB&#xD;
             criteria as specified in the appendix I) with following characteristics: Subject is&#xD;
             not a candidate for high-dose chemotherapy and stem cell transplantation due to age,&#xD;
             presence of comorbidities likely to have a negative impact on tolerability of HDT-SCT,&#xD;
             or subject preference&#xD;
&#xD;
          2. Measurable disease, defined as any quantifiable monoclonal protein value, defined by&#xD;
             at least one of the following three measurements (Durie et al., 2006):&#xD;
&#xD;
               -  Serum M-protein ≥ 10g/l&#xD;
&#xD;
               -  Urine light-chain (M-protein) of ≥ 200 mg/24 hours&#xD;
&#xD;
               -  Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal&#xD;
&#xD;
          3. Age&gt;18 years&#xD;
&#xD;
          4. WHO performance status 0-3 (WHO=3 is allowed only when related to MM and not to&#xD;
             co-morbid conditions) (see appendix III)&#xD;
&#xD;
          5. For women of childbearing potential: negative pregnancy test at inclusion&#xD;
&#xD;
          6. All patients must be willing and capable to use adequate contraception during the&#xD;
             complete therapy.&#xD;
&#xD;
          7. All patients must agree to abstain from donating blood while on study&#xD;
&#xD;
          8. Ability to understand character and individual consequences of the clinical trial&#xD;
&#xD;
          9. Written informed consent (must be available before enrolment in the trial)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects presenting any of the following criteria will not be included in the trial&#xD;
&#xD;
               1. Patient has known hypersensitivity to bortezomib, bendamustine and prednisone or&#xD;
                  to any of the constituent compounds (incl. boron and mannitol).&#xD;
&#xD;
               2. Systemic AL amyloidosis (except for patients with AL amyloidosis of the skin or&#xD;
                  the bone marrow)&#xD;
&#xD;
               3. Chemotherapy or radiotherapy during the past 5 years except patients with local&#xD;
                  radiotherapy in case of local myeloma progression. (Note: patients may have&#xD;
                  received a cumulative dose of up to 160 mg of dexamethasone or equivalent as&#xD;
                  emergency therapy within 3 weeks prior to study entry.)&#xD;
&#xD;
               4. Plasma cell leukemia which requires the presence of 20% of plasma cell in&#xD;
                  peripheral blood leukocytes and at least 2 plasma cells/nl.&#xD;
&#xD;
               5. Severe cardiac dysfunction (NYHA classification III-IV, see appendix III)&#xD;
&#xD;
               6. Significant hepatic dysfunction (serum bilirubin ≥ 2 mg/dl or ASAT and/or ALAT ≥&#xD;
                  2.5 times normal level), unless related to myeloma&#xD;
&#xD;
               7. Patients known to be HIV-positive&#xD;
&#xD;
               8. Patients with active, uncontrolled infections&#xD;
&#xD;
               9. Patients with peripheral neuropathy or neuropathic pain of CTC grade 2 or higher&#xD;
                  (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)&#xD;
                  Version 4.0, see appendix V)&#xD;
&#xD;
              10. Second malignancy during the past 5 years except:&#xD;
&#xD;
          -  Adequately treated basal cell or squamous cell skin cancer, or&#xD;
&#xD;
          -  Carcinoma in situ of the cervix, or&#xD;
&#xD;
          -  Prostate cancer &lt; Gleason score 6 with undetectable prostate-specific antigen (PSA)&#xD;
             over 12 months, or&#xD;
&#xD;
          -  Ductal breast carcinoma in situ with full surgical resection (i.e., negative margins),&#xD;
             or&#xD;
&#xD;
          -  Similar malignant condition as a.- d. with an expected5-year disease free survival&#xD;
             larger than 95% 11. Patients with acute diffuse infiltrative pulmonary and pericardial&#xD;
             disease 12. Autoimmune hemolytic anemia with positive Coombs test or immune&#xD;
             thrombocytopenia 13. Platelet count &lt; 50 x 109/l (transfusion support within 14 days&#xD;
             before the test is not allowed), unless related to myeloma 14. Hemoglobin &lt; 7.5g/dl,&#xD;
             unless related to myeloma 15. Absolute neutrophil count (ANC) &lt; 0.75 x 109/l (the use&#xD;
             of colony stimulating factors within 14 days before the test is not allowed), unless&#xD;
             related to myeloma 16. Pregnancy and lactation 17. Participation in other clinical&#xD;
             trials within one month prior to enrolment except for supportive care studies and&#xD;
             vaccination studies. (Note: this does not include long-term follow-up periods without&#xD;
             active drug treatment of previous studies during the last 6 months).&#xD;
&#xD;
        No subject will be allowed to enrol in this trial more than once.&#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>Wolfgang Knauf, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hematology/Oncology,Bethanien hospital, Im Pruefling 17-19, 60389 Frankfurt/M., Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mannheimer Onkologie Praxis</name>
      <address>
        <city>Mannheim</city>
        <state>Ba-Wü</state>
        <zip>68161</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hämatologisch-Onkologische gemeinschaftspraxis</name>
      <address>
        <city>Augsburg</city>
        <state>Bayern</state>
        <zip>86150</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dr. R. Schlag/Dr. B. Schöttker</name>
      <address>
        <city>Würzburg</city>
        <state>Bayern</state>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologische Schwerpunktpraxis</name>
      <address>
        <city>Heidelberg</city>
        <state>BW</state>
        <zip>69115</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Klinik V, Universitätsklinikum Heidelberg, Sektion Multiples Myelom</name>
      <address>
        <city>Heidelberg</city>
        <state>BW</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologische Schwerpunktpraxis Dr. G. Kojouharoff</name>
      <address>
        <city>Darmstadt</city>
        <state>Hessen</state>
        <zip>64295</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanienkrankenhaus</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agaplesion Markus Krankenhaus gGmbH, Medizinisches Versorgungszentrum</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60431</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologisches Ambulanzzentrum Hannover am Diakoniekrankenhaus Henriettenstift gGmbH</name>
      <address>
        <city>Hannover</city>
        <state>NRW</state>
        <zip>30171</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologische Gemeinschaftspraxis</name>
      <address>
        <city>Köln</city>
        <state>NRW</state>
        <zip>50677</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Idar-Oberstein GmbH, Innere Medizin I</name>
      <address>
        <city>Idar-Oberstein</city>
        <state>Rh-Pfalz</state>
        <zip>55743</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologische Schwerpunktpraxis Speyer</name>
      <address>
        <city>Speyer</city>
        <state>RP</state>
        <zip>67346</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtische Klinikum Dessau</name>
      <address>
        <city>Dessau</city>
        <state>Sachsen-Anhalt</state>
        <zip>06847</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Aschaffenburg, Med. Klinik II</name>
      <address>
        <city>Aschaffenburg</city>
        <zip>63739</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologische Praxis Oldenburg/Delmenhorst</name>
      <address>
        <city>Oldenburg</city>
        <zip>26121</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Knauf W, Dingeldein G, Schlag R, Welslau M, Moehler T, Terzer T, Walter S, Habermehl C, Kunz C, Goldschmidt H, Raab MS; BPV trial group. First-line therapy with bendamustine/prednisone/bortezomib-A GMMG trial for non-transplant eligible symptomatic multiple myeloma patients. Eur J Haematol. 2020 Aug;105(2):116-125. doi: 10.1111/ejh.13409. Epub 2020 May 26.</citation>
    <PMID>32155662</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>October 14, 2020</last_update_submitted>
  <last_update_submitted_qc>October 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Heidelberg</investigator_affiliation>
    <investigator_full_name>Dr. Marc Raab</investigator_full_name>
    <investigator_title>Marc S. Raab MD, Medical Hospital V (Hematology, Oncology, Rheumatology), Section multiple myeloma</investigator_title>
  </responsible_party>
  <keyword>Newly diagnosed symptomatic multiple myeloma</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>Prednisone</mesh_term>
    <mesh_term>Bortezomib</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/NCT02237261
org study id: BPV
secondary id: 2013-005485-19
nct id: NCT02237261
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to improve efficacy of treatment for patients with newly
      diagnosed multiple myeloma who are not eligible for high-dose chemotherapy followed by
      autologous stem cell transplantation by Bendamustin, Bortezomib (Velcade), and Prednisone.
1. Objectives Primary

           -Therapeutic efficacy of BPV regimen for multiple myeloma as evidenced by the overall
           response defined as partial response (PR) or better

           Secondary

             -  to assess overall survival (OS) and progression-free survival (PFS)

             -  to determine response duration

             -  to investigate improvements of renal function

             -  to evaluate safety and toxicity (with respect to adverse events of CTCAE grade ≧3
                and SAEs)

             -  to analyze the efficacy for genetically defined subgroups of myeloma patients based
                on iFISH and gene-expression profiling

        2. Investigational Medicinal Products Bortezomib Bendamustine both in combination with
           Prednisone
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR) of BPV
time frame: 2 years
description: ORR is defined as PR or better
measure: Number and percentage of patients achieving a complete response
time frame: 2 years
description: Number and percentage of patients achieving a complete response
measure: Progression-free survival (PFS)
time frame: 2 years
description: PFS defined as time from registration to progression or death whatever comes first
measure: Overall survival (OS)
time frame: 2 years
description: OS defined as time from registration to time of death from any cause.
measure: Time-to-progression (TTP)
time frame: 2 years
description: TTP defined as time from registration to disease progression. TTP is censored at time of deaths which are not caused by progression.
measure: Disease-free survival (DFS)
time frame: 2 years
description: DFS defined as time from start of CR to relapse or death from any cause whichever comes first. Patients evaluable for DFS are patients in complete Response.
measure: Duration of response (DOR)
time frame: 2 years
description: DOR defined as time from first observation of PR to the time of disease progression.
measure: Renal response according to IMWG (CRrenal, PRrenal, MRrenal)
time frame: 2 years
description: percent of patients with recovery/improvement of renal function (for patients with impared renal finction at baseline)
measure: Toxicity (with respect to adverse events of CTCAE grade ≧3 and SAEs)
time frame: 2 years
description: toxicity during study therapy with AE of CTC grade ≧ 3, as well as neuropathy of CTC grade 2, measured by CTC-AE (v4.0).
measure: Time to objective Response (TOR)
time frame: 2 years
description: TOR defined as time from registration to achieving an objective response for patients achieving an objective Response.
measure: Time to treatment failure (TTF)
time frame: 2 years
description: TTF is defined as time from registration to treatment discontinuation for any reason, including disease progression, Treatment toxicity, patient preference or death.
arm group label: Bendamustine, Bortezomib, Prednisone
arm group type: Experimental
description: Induction: Bortezomib: 1.3 mg/m2 subcutaneous for 7 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison: : 60 mg/m2 per os for 4 days Consolidation: Bortezomib: 1.3 mg/m2 subcutaneous for 4 days and Bendamustine: 90 mg/m2 intravenous for 2 days and in addition Prednison 60 mg/m2 per os for 4 days
intervention type: Drug
intervention name: Bendamustine, Bortezomib, Prednisone
description: Cycle 1 (d1-42) - Induction:
Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4
Cycle 2-9 (d1-28) - Consolidation:
Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4
arm group label: Bendamustine, Bortezomib, Prednisone
other name: Velcade (Bortezomib)
other name: Levact (Bendamustine)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wolfgang Knauf, MD
role: Study Chair
affiliation: Hematology/Oncology,Bethanien hospital, Im Pruefling 17-19, 60389 Frankfurt/M., Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
citation: Knauf W, Dingeldein G, Schlag R, Welslau M, Moehler T, Terzer T, Walter S, Habermehl C, Kunz C, Goldschmidt H, Raab MS; BPV trial group. First-line therapy with bendamustine/prednisone/bortezomib-A GMMG trial for non-transplant eligible symptomatic multiple myeloma patients. Eur J Haematol. 2020 Aug;105(2):116-125. doi: 10.1111/ejh.13409. Epub 2020 May 26.
PMID: 32155662
responsible party type: Principal Investigator
investigator affiliation: University Hospital Heidelberg
investigator full name: Dr. Marc Raab
investigator title: Marc S. Raab MD, Medical Hospital V (Hematology, Oncology, Rheumatology), Section multiple myeloma
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Prednisone
mesh term: Bortezomib
mesh term: Bendamustine Hydrochloride