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A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04814615
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : June 7, 2023
Sponsor:
Information provided by (Responsible Party):
Gary Ulaner, Hoag Memorial Hospital Presbyterian

Study Description
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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
Multiple Myeloma 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : March 8, 2021
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : March 15, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Daratumumab

Arms and Interventions
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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 Name: CD38-targeted imaging


Outcome Measures
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Primary Outcome Measures :
  1. 89Zr-daratumumab PET/CT for pre-treatment multiple myeloma imaging [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: up to 3 years ]
    Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814615


Contacts
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Contact: Gary Ulaner, MD, PhD 9495570252 gary.ulaner@hoag.org
Contact: Beth Thomsen 9495570285 beth.thomsen@hoag.org

Locations
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United States, California
Hoag Memorial Hospital Presbyterian Recruiting
Irvine, California, United States, 92614
Contact: Beth Thomsen       clinicaltrials@hoag.org   
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Investigators
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Study Director: Deborah Fridman, PsyD, RN Hoag Memorial Hospital Presbyterian
More Information
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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: March 24, 2021    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Ulaner, Hoag Memorial Hospital Presbyterian:
Multiple Myeloma
89Zr-daratumumab
Dartumumab
PET/CT
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Daratumumab
Antineoplastic Agents