<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/NCT04467281</url>
  </required_header>
  <id_info>
    <org_study_id>20-098</org_study_id>
    <nct_id>NCT04467281</nct_id>
  </id_info>
  <brief_title>A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma</brief_title>
  <official_title>A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with&#xD;
      PET/CT scans is a practical and effective way to view and monitor multiple myeloma in&#xD;
      participants before and during their treatment with daratumumab. We also want to see if&#xD;
      89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if&#xD;
      they can better locate any leftover disease following treatment compared to the standard&#xD;
      imaging methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    PI left institution and study is being transferred.&#xD;
  </why_stopped>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">February 26, 2021</completion_date>
  <primary_completion_date type="Actual">February 26, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This will be a phase II clinical trial.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of patient's with positive tumors</measure>
    <time_frame>1 year</time_frame>
    <description>Uptake of FDG PET/CT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy</measure>
    <time_frame>1 year</time_frame>
    <description>The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>89Zr-DFO-daratumumab PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre treatment evaluation: 1) Standard of Care (SoC) labs, imaging, blind bone marrow biopsy. 2) Baseline research 89 Zr DFO daratumumab PET/CT 3) Possible biopsy of 89 Zr DFO daratumumab avid lesion Treatment: Daratumumab containing combination therapy (up to 12 cycles, 4 weeks/cycle). SoC labs, imaging, and blind bone marrow biopsies until complete response (CR) is suspected or 12 cycles are completed.&#xD;
Post treatment evaluation:1) SoC labs, imaging, and blind bone marrow biopsy 2) SoC minimal residual disease (MRD) analysis by next generation sequencing 3) Follow up research 89 Zr DFO daratumumab PET/CT 4) Possible biopsy of 89 Zr DFO daratumumab avid lesion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>89Zr-DFO-daratumumab</intervention_name>
    <description>Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.</description>
    <arm_group_label>89Zr-DFO-daratumumab PET/CT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PET/CT</intervention_name>
    <description>Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.</description>
    <arm_group_label>89Zr-DFO-daratumumab PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 21 years&#xD;
&#xD;
          -  Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma&#xD;
&#xD;
          -  At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol&#xD;
             enrollment&#xD;
&#xD;
          -  ECOG performance status 0 to 2&#xD;
&#xD;
          -  Participant is capable of having an informed consent discussion (Legally Authorized&#xD;
             Representatives are not permitted to sign on a participant's behalf).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life expectancy &lt; 12 months&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners&#xD;
             may not be able to function with patients over 450 pounds.&#xD;
&#xD;
          -  History of anaphylactic reaction to humanized or human antibodies.&#xD;
&#xD;
          -  Previous treatment with daratumumab. Previous treatment with other myeloma therapies&#xD;
             will be allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marius Mayerhoefer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>June 30, 2022</last_update_submitted>
  <last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CD38-Targeted ImmunoPET</keyword>
  <keyword>20-098</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>Daratumumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </patient_data>
  <!-- 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/NCT04467281
org study id: 20-098
nct id: NCT04467281
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with
      PET/CT scans is a practical and effective way to view and monitor multiple myeloma in
      participants before and during their treatment with daratumumab. We also want to see if
      89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if
      they can better locate any leftover disease following treatment compared to the standard
      imaging methods.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This will be a phase II clinical trial.
primary purpose: Diagnostic
masking: None (Open Label)
measure: number of patient's with positive tumors
time frame: 1 year
description: Uptake of FDG PET/CT
measure: assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy
time frame: 1 year
description: The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response.
arm group label: 89Zr-DFO-daratumumab PET/CT
arm group type: Experimental
description: Pre treatment evaluation: 1) Standard of Care (SoC) labs, imaging, blind bone marrow biopsy. 2) Baseline research 89 Zr DFO daratumumab PET/CT 3) Possible biopsy of 89 Zr DFO daratumumab avid lesion Treatment: Daratumumab containing combination therapy (up to 12 cycles, 4 weeks/cycle). SoC labs, imaging, and blind bone marrow biopsies until complete response (CR) is suspected or 12 cycles are completed.
Post treatment evaluation:1) SoC labs, imaging, and blind bone marrow biopsy 2) SoC minimal residual disease (MRD) analysis by next generation sequencing 3) Follow up research 89 Zr DFO daratumumab PET/CT 4) Possible biopsy of 89 Zr DFO daratumumab avid lesion
intervention type: Drug
intervention name: 89Zr-DFO-daratumumab
description: Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.
arm group label: 89Zr-DFO-daratumumab PET/CT
intervention type: Diagnostic Test
intervention name: PET/CT
description: Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.
arm group label: 89Zr-DFO-daratumumab PET/CT
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Marius Mayerhoefer, MD, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Daratumumab
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.