<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/NCT02204553</url>
  </required_header>
  <id_info>
    <org_study_id>CLBH589DUS94X</org_study_id>
    <nct_id>NCT02204553</nct_id>
  </id_info>
  <brief_title>Expanded Treatment Prot of Panobinostat in Combo w/ Bortez and Dex in Pts w/ Relapsed and/or Refractory Multiple Myeloma</brief_title>
  <official_title>An Expanded Treatment Protocol of Panobinostat (LBH589) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma Who Have Had at Least One Prior Line of Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <brief_summary>
    <textblock>
      This will be a multi-center, open label, expanded treatment protocol of panobinostat,&#xD;
      bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.&#xD;
      Panobinostat will be administered at a starting dose of 20mg orally three times a week (every&#xD;
      other day) for two weeks on and one week off, with dose adjustments permitted based on&#xD;
      observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously,&#xD;
      twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients&#xD;
      who have achieved stable disease or better by modified EBMT 1998 criteria may continue&#xD;
      combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up&#xD;
      to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable&#xD;
      disease or better may continue on therapy at the discretion of their investigator until&#xD;
      September 2015 or until drug is commercially available, whichever comes first. Patients who&#xD;
      have not achieved at least stable disease by 8 cycles must discontinue from study treatment.&#xD;
      Dexamethasone will be administered on the day of and the day immediately following bortezomib&#xD;
      treatment. Patients will not receive any study treatment during the third week of each cycle.&#xD;
      Cycles will be defined as 21 days of treatment. Investigators may not add any other&#xD;
      anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study&#xD;
      treatment. Patients will remain on study until disease progression, unacceptable toxicity, or&#xD;
      end of the study&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <condition>Multiple Myeloma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Panobinostat</intervention_name>
    <description>Treating patients with relapsed and/or refractory Multiple Myeloma</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This study is intended for patients with relapsed and/or refractory multiple myeloma,&#xD;
             who have received at least one prior line of therapy. Patients must require&#xD;
             retreatment as per IMWG definitions (Kyle et al 2003). Approximately 50-100 patients&#xD;
             are expected to be enrolled into this trial.&#xD;
&#xD;
          -  Patient has a previous diagnosis of multiple myeloma, based on IMWG 2003 definitions&#xD;
             all three of the following criteria had been met:&#xD;
&#xD;
          -  Monoclonal immunoglobulin (M component) on electrophoresis, and on immunofixation on&#xD;
             serum or on total 24 hour urine (or demonstration of M protein in cytoplasm of plasma&#xD;
             cell for non secretory myeloma).&#xD;
&#xD;
          -  Bone marrow (clonal) plasma cells ≥ 10% or biopsy proven plasmacytoma&#xD;
&#xD;
          -  Related organ or tissue impairment (CRAB symptoms: anemia, hypercalcemia, lytic bone&#xD;
             lesions, renal insufficiency, hyperviscosity, amyloidosis or recurrent infections)&#xD;
&#xD;
          -  Patients who have received allogeneic stem cell transplant and do not have active&#xD;
             graft vs host disease requiring immunosuppressive therapy are eligible.&#xD;
&#xD;
          -  Patient with multiple myeloma (per IMWG 2003 definition) that is relapsed and/or&#xD;
             refractory to at least one prior line of therapy and requires retreatment&#xD;
&#xD;
          -  Relapsed-and-refractory to a therapy, provided that the patient meets any of the&#xD;
             following conditions:&#xD;
&#xD;
          -  Relapsed, defined by disease that recurred in a patient that responded under a prior&#xD;
             therapy, by reaching a MR or better, and had not progressed under this therapy nor up&#xD;
             to 60 days of last dose of this therapy. Patients who previously responded to&#xD;
             treatment with BTZ are eligible.&#xD;
&#xD;
          -  Patient has relapsed to at least one prior line and patient was refractory to at least&#xD;
             one prior line by either not reaching a MR, or progressed while under this therapy, or&#xD;
             within 60 days of its last dose. Patients previously refractory to BTZ are also&#xD;
             eligible.&#xD;
&#xD;
          -  Patients with primary refractory disease are eligible.&#xD;
&#xD;
          -  Patients who have previously received high dose therapy/autologous stem cell&#xD;
             transplant are eligible&#xD;
&#xD;
          -  Patients who have received allogeneic stem cell transplant and do not have active&#xD;
             graft vs host disease requiring immunosuppressive therapy are eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has shown intolerance to bortezomib, dexamethasone or panobinostat or has any&#xD;
             contraindications to any of these therapies. following available prescribing&#xD;
             information&#xD;
&#xD;
          -  Allogeneic stem cell transplant recipient presenting with graft versus host disease&#xD;
             either active or requiring immunosuppression&#xD;
&#xD;
          -  Patient has grade ≥ 2 peripheral neuropathy or grade 1 peripheral neuropathy with pain&#xD;
             on clinical examination within 14 days of treatment&#xD;
&#xD;
          -  Patient taking any anti-cancer therapy concomitantly&#xD;
&#xD;
          -  Patient has second primary malignancy &lt; 3 years of first dose of study treatment&#xD;
             (except for treated basal or squamous cell carcinoma, or in situ cancer of the cervix)&#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>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ironwood Cancer and Research Centers Ironwood Cancer</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group Dept of Highlands Oncology Grp</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates Cancer Center</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Hematology/Oncology Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Center Stanford Cancer Institute (2)</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington U Medical Center Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer Institute Univ. Cancer Institute</name>
      <address>
        <city>Boyton Beach</city>
        <state>Florida</state>
        <zip>33426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Cancer Institute Memorial Cancer Inst.</name>
      <address>
        <city>Hollywod</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakes Research SC</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University School of Medicine/Winship Cancer Institute Winship Cancer Institute (2)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stormont-Vail Cancer Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Clinic Hematology Oncology Clinic</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital of Baltimore Sinai Hospital, Baltimore</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bronson Battle Creek Cancer Care Center</name>
      <address>
        <city>Battle Creek</city>
        <state>Michigan</state>
        <zip>49017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center Cancer Institute</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216-9941</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Medical Center Research Med. Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology West, PC Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology of Central New Jersey</name>
      <address>
        <city>Little Silver</city>
        <state>New Jersey</state>
        <zip>07739</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Coleman, MD M. Coleman, MD (2)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Centers of the Carolinas GHS Cancer Institute</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellmont Medical Associates</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology Texas Oncology - Arlington</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology TX Oncology Baylor</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Utah Cancer Associates SC</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84403-3105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates Virginia Oncology Assoc. (2)</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Valley Hematology and Oncology</name>
      <address>
        <city>Appleton</city>
        <state>Wisconsin</state>
        <zip>54915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>January 4, 2016</last_update_submitted>
  <last_update_submitted_qc>January 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Panobinostat</keyword>
  <keyword>LBH589</keyword>
  <keyword>Expanded Access</keyword>
  <keyword>EAP, ETP</keyword>
  <keyword>Expanded Treatment</keyword>
  <keyword>Bortezomib</keyword>
  <keyword>HDAC</keyword>
  <keyword>histone deacetylace inhibitor</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>Panobinostat</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/NCT02204553
org study id: CLBH589DUS94X
nct id: NCT02204553
lead sponsor: 
This will be a multi-center, open label, expanded treatment protocol of panobinostat,
      bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma.
      Panobinostat will be administered at a starting dose of 20mg orally three times a week (every
      other day) for two weeks on and one week off, with dose adjustments permitted based on
      observed toxicity. Bortezomib will be administered either intravenously or sub-cutaneously,
      twice a week on days 1 and 4, two weeks on 1 week off. After 8 cycles of treatment, patients
      who have achieved stable disease or better by modified EBMT 1998 criteria may continue
      combination therapy with bortezomib dosing changed to days 1 and 8 of a 21 day cycle for up
      to 48 weeks of therapy. At the end of the treatment period, (48 weeks) patients with stable
      disease or better may continue on therapy at the discretion of their investigator until
      September 2015 or until drug is commercially available, whichever comes first. Patients who
      have not achieved at least stable disease by 8 cycles must discontinue from study treatment.
      Dexamethasone will be administered on the day of and the day immediately following bortezomib
      treatment. Patients will not receive any study treatment during the third week of each cycle.
      Cycles will be defined as 21 days of treatment. Investigators may not add any other
      anti-myeloma agents (with the exception of bisphosphonates) while patients remain on study
      treatment. Patients will remain on study until disease progression, unacceptable toxicity, or
      end of the study
intervention type: Drug
intervention name: Panobinostat
description: Treating patients with relapsed and/or refractory Multiple Myeloma
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Panobinostat