A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

Sponsor
Hoag Memorial Hospital Presbyterian (Other)
Overall Status
Recruiting
CT.gov ID
NCT04814615
Collaborator
(none)
60
1
1
48.2
1.2

Study Details

Study Description

Brief Summary

Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma in a PET scanner. A phase I study of 89Zr-DFO-daratumumab demonstrated safety and successful visualization of myeloma with 89Zr-DFO-daratumumab. This will be a phase II study of 89Zr-DFO-daratumumab to evaluate potential clinical applications of this novel imaging agent.

Condition or Disease Intervention/Treatment Phase
  • Drug: 89Zr-daratumumab PET/CT
Phase 2

Detailed Description

This will be a phase II clinical trial to assess the potential clinical value of 89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for daratumumab containing combination therapy will be enrolled. Prior to therapy, current standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be performed. Patients will then undergo standard of care therapy for myeloma as defined by a medical oncologist and SoC response assessments as defined by the International Myeloma Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of care minimal residual disease (MRD) assessment will be performed. This design will determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring and localizing disease prior to therapy, if immunoPET can predict response to therapy, and how immunoPET compares with current methods of detecting MRD after therapy.

The therapy in this trial is standard of care. The research component is the addition of a novel immunoPET imaging test before and after standard of care therapy, to determine if the novel imaging test adds value over current measures of myeloma disease burden.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
Individual dose of 89Zr-DFO-daratumumab will be requested from Memorial Sloan Kettering Cancer Center and received at the Hoag Family Cancer Institute radiopharmacy for each individual 89Zr-DFO-daratumumab administration.Individual dose of 89Zr-DFO-daratumumab will be requested from Memorial Sloan Kettering Cancer Center and received at the Hoag Family Cancer Institute radiopharmacy for each individual 89Zr-DFO-daratumumab administration.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
Actual Study Start Date :
Mar 8, 2021
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Mar 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: CD38-positive multiple myeloma

Patients with CD38 positive multiple myeloma with be enrolled. Patients will undergo pretreatment evaluation with standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Patients will then undergo a course of standard of care therapy as defined by a medical oncologist. Following therapy, patients will repeat standard of care diagnostic tests, as well as experimental 89Zr-daratumumab PET/CT. Data analysis will be performed to evaluate 89Zr-daratumumab against standard of care diagnostic tests for the detection and localization of active disease before and after therapy.

Drug: 89Zr-daratumumab PET/CT
CD38-targeting imaging
Other Names:
  • CD38-targeted imaging
  • Outcome Measures

    Primary Outcome Measures

    1. 89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging [up to 3 years]

      89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma prior to therapy

    2. 89Zr-daratumumab PET/CT for post-treatment multiple myeloma imaging [up to 3 years]

      89Zr-daratumumab PET/CT will be compared against standard of care laboratory and imaging measurements of multiple myeloma following therapy

    3. Prediction of response to therapy [up to 3 years]

      Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male or female ≥ 21 years of age

    2. Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma

    3. At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment

    4. ECOG performance status 0 to 2

    5. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

    Exclusion Criteria:
    1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

    2. Life expectancy < 12 months

    3. 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.

    4. History of anaphylactic reaction to humanized or human antibodies.

    5. Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hoag Memorial Hospital Presbyterian Irvine California United States 92614

    Sponsors and Collaborators

    • Hoag Memorial Hospital Presbyterian

    Investigators

    • Study Director: Deborah Fridman, PsyD, RN, Hoag Memorial Hospital Presbyterian

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Ulaner, Director Molecular Imaging and Therapy, Hoag Memorial Hospital Presbyterian
    ClinicalTrials.gov Identifier:
    NCT04814615
    Other Study ID Numbers:
    • 177-20-CA
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gary Ulaner, Director Molecular Imaging and Therapy, Hoag Memorial Hospital Presbyterian
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022