<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/NCT01697839</url>
  </required_header>
  <id_info>
    <org_study_id>X05392</org_study_id>
    <nct_id>NCT01697839</nct_id>
  </id_info>
  <brief_title>Serum Vitamin D Levels and Peripheral Neuropathy Among Multiple Myeloma Patients</brief_title>
  <official_title>Correlation Between Serum Vitamin D Levels and the Incidence of Peripheral Neuropathy Among Multiple Myeloma Patients Who Have Previously Received Treatment With Bortezomib or Thalidomide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oncotherapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Millennium Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Oncotherapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study investigating the relationship between vitamin D and peripheral&#xD;
      neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or&#xD;
      thalidomide. The study consists of a screening period of up to 14 days, followed by a single&#xD;
      assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic&#xD;
      pain, and markers of depression. Patient charts will also be utilized to assess the frequency&#xD;
      of skeletal-related events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 10% of myeloma patients present at diagnosis with clinical neuropathy although&#xD;
      studies reveal as many as 1/3 may have abnormal electrophysiological examinations. Baseline&#xD;
      neuropathic abnormal findings are exacerbated by many myeloma treatments, especially&#xD;
      bortezomib, thalidomide, and to a lesser extent lenalidomide. Several studies suggest that&#xD;
      vitamin D supplementation may help reduce the symptoms of neuropathy.In this prospective&#xD;
      study, we will investigate the relationship between vitamin D and PN among MM patients&#xD;
      treated with either bortezomib or thalidomide. The study consists of a screening period of up&#xD;
      to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and&#xD;
      severity of PN, neuropathic pain, and markers of depression. Patient charts will also be&#xD;
      utilized to assess the frequency of skeletal-related events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum vitamin D levels</measure>
    <time_frame>Day 1</time_frame>
    <description>Correlation of serum vitamin D levels to the incidence and severity of anti-myeloma treatment-induced PN/ neuropathic pain among MM patients previously exposed to bortezomib and/or thalidomide</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skeletal related event</measure>
    <time_frame>Day 1</time_frame>
    <description>Correlation between vitamin D levels and skeletal-related events (pathologic fracture, spinal cord compression or collapse, or surgery or radiotherapy to bone) among MM patients</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Markers of depression</measure>
    <time_frame>Day 1</time_frame>
    <description>Correlation between vitamin D levels and markers of depression for MM patients</description>
  </other_outcome>
  <enrollment type="Actual">110</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Peripheral Neuropathy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, serum, white blood cells, red blood cells&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntary written informed consent before performance of any study-related procedure&#xD;
             not part of normal medical care, with the understanding that consent may be withdrawn&#xD;
             by the subject at any time without prejudice to future medical care.&#xD;
&#xD;
          -  Prior diagnosis of multiple myeloma based on standard criteria (Durie 1986)&#xD;
&#xD;
          -  Received consecutive, prior treatment for MM with a regimen consisting of at least 16&#xD;
             consecutive weeks of bortezomib or 16 consecutive weeks of thalidomide prior to the&#xD;
             Day of Assessment&#xD;
&#xD;
          -  The 16 weeks of consecutive treatment must have included at least one of the following&#xD;
             doses and schedules:&#xD;
&#xD;
               -  Bortezomib: ≥ 1.0 mg/m² dosed 3 or more times per each 4-week period&#xD;
&#xD;
               -  Thalidomide: ≥ 50 mg/day dosed daily&#xD;
&#xD;
          -  The qualifying regimen may include both bortezomib and thalidomide. However, the above&#xD;
             inclusion requirements need only be satisfied by either one of the agents.&#xD;
&#xD;
          -  Age ≥18 years at the time of signing the informed consent form&#xD;
&#xD;
          -  Able to adhere to the study visit schedule and other protocol requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal&#xD;
             protein (M-protein) and skin changes (POEMS) syndrome (Bardwick 1980)&#xD;
&#xD;
          -  Plasma cell leukemia&#xD;
&#xD;
          -  Primary amyloidosis&#xD;
&#xD;
          -  Vitamin D level assessment occurring within the 12 months preceding the Day of&#xD;
             Assessment&#xD;
&#xD;
          -  Vitamin D non-dietary oral supplementation &gt; 1200 IU per day for &gt; 30 total days&#xD;
             within the 12 month period preceding the Day of Assessment&#xD;
&#xD;
          -  Serious medical or psychiatric illness likely to interfere with participation in this&#xD;
             clinical study.&#xD;
&#xD;
          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that&#xD;
             would prevent the subject from signing the informed consent form&#xD;
&#xD;
          -  Any condition, including the presence of laboratory abnormalities, which places the&#xD;
             subject at unacceptable risk if he/she were to participate in the study or confounds&#xD;
             the ability to interpret data from the study.&#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>James R. Berenson, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oncotherapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaver Medical Group</name>
      <address>
        <city>Highland</city>
        <state>California</state>
        <zip>92346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James R. Berenson M.D., Inc.</name>
      <address>
        <city>West Hollywood</city>
        <state>California</state>
        <zip>90069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Hinsdale</city>
        <state>Illinois</state>
        <zip>60521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>March 2, 2018</last_update_submitted>
  <last_update_submitted_qc>March 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01697839
org study id: X05392
nct id: NCT01697839
lead sponsor: 
collaborator: 
has dmc: No
This is a prospective study investigating the relationship between vitamin D and peripheral
      neuropathy (PN) among multiple myeloma (MM) patients treated with either bortezomib or
      thalidomide. The study consists of a screening period of up to 14 days, followed by a single
      assessment visit to evaluate vitamin D levels, incidence and severity of PN, neuropathic
      pain, and markers of depression. Patient charts will also be utilized to assess the frequency
      of skeletal-related events.
Approximately 10% of myeloma patients present at diagnosis with clinical neuropathy although
      studies reveal as many as 1/3 may have abnormal electrophysiological examinations. Baseline
      neuropathic abnormal findings are exacerbated by many myeloma treatments, especially
      bortezomib, thalidomide, and to a lesser extent lenalidomide. Several studies suggest that
      vitamin D supplementation may help reduce the symptoms of neuropathy.In this prospective
      study, we will investigate the relationship between vitamin D and PN among MM patients
      treated with either bortezomib or thalidomide. The study consists of a screening period of up
      to 14 days, followed by a single assessment visit to evaluate vitamin D levels, incidence and
      severity of PN, neuropathic pain, and markers of depression. Patient charts will also be
      utilized to assess the frequency of skeletal-related events.
observational model: Case-Only
time perspective: Prospective
measure: Serum vitamin D levels
time frame: Day 1
description: Correlation of serum vitamin D levels to the incidence and severity of anti-myeloma treatment-induced PN/ neuropathic pain among MM patients previously exposed to bortezomib and/or thalidomide
measure: Skeletal related event
time frame: Day 1
description: Correlation between vitamin D levels and skeletal-related events (pathologic fracture, spinal cord compression or collapse, or surgery or radiotherapy to bone) among MM patients
measure: Markers of depression
time frame: Day 1
description: Correlation between vitamin D levels and markers of depression for MM patients
whole blood, serum, white blood cells, red blood cells
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James R. Berenson, M.D.
role: Principal Investigator
affiliation: Oncotherapeutics
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Peripheral Nervous System Diseases