A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

June 23, 2023 updated by: Gary Ulaner, Hoag Memorial Hospital Presbyterian

A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92614
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
        • Principal Investigator:
          • C. Ola Landgren, MD, PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 3 years
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
up to 3 years
Prediction of response to therapy
Time Frame: up to 3 years
Determine if tumor uptake of 89Zr-daratumumab predicts response to therapy
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoag Memorial Hospital Presbyterian

Investigators

  • Study Director: Leila Andreas, MS, HOAG Memorial Hospital Presbyterian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2021

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 24, 2021

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 177-20-CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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