search
Back to results

A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma

Primary Purpose

Multiple Myeloma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
89Zr-DFO-daratumumab
PET/CT
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring CD38-Targeted ImmunoPET, 20-098

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 21 years
  • Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
  • At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment
  • ECOG performance status 0 to 2
  • Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf).

Exclusion Criteria:

  • Life expectancy < 12 months
  • Pregnancy or lactation
  • Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds.
  • History of anaphylactic reaction to humanized or human antibodies.
  • Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    89Zr-DFO-daratumumab PET/CT

    Arm 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

    Outcomes

    Primary Outcome Measures

    number of patient's with positive tumors
    Uptake of FDG PET/CT

    Secondary Outcome Measures

    assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy
    The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response.

    Full Information

    First Posted
    July 2, 2020
    Last Updated
    June 30, 2022
    Sponsor
    Memorial Sloan Kettering Cancer Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04467281
    Brief Title
    A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma
    Official Title
    A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI left institution and study is being transferred.
    Study Start Date
    June 30, 2020 (Actual)
    Primary Completion Date
    February 26, 2021 (Actual)
    Study Completion Date
    February 26, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Memorial Sloan Kettering Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma
    Keywords
    CD38-Targeted ImmunoPET, 20-098

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    This will be a phase II clinical trial.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    89Zr-DFO-daratumumab PET/CT
    Arm Type
    Experimental
    Arm 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(s)
    89Zr-DFO-daratumumab
    Intervention 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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    PET/CT
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    number of patient's with positive tumors
    Description
    Uptake of FDG PET/CT
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 21 years Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment ECOG performance status 0 to 2 Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf). Exclusion Criteria: Life expectancy < 12 months Pregnancy or lactation Patients who cannot undergo PET/CT scanning because of weight limits. PET/CT scanners may not be able to function with patients over 450 pounds. History of anaphylactic reaction to humanized or human antibodies. Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marius Mayerhoefer, MD, PhD
    Organizational Affiliation
    Memorial Sloan Kettering Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan 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.
    Links:
    URL
    http://www.mskcc.org/mskcc/html/44.cfm
    Description
    Memorial Sloan Kettering Cancer Center

    Learn more about this trial

    A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma

    We'll reach out to this number within 24 hrs