A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Male or female ≥ 21 years of age
  • 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
  • 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:

  • Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
  • Life expectancy < 12 months
  • 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.

Additional Trial Information

Phase 2

Enrollment: 60 patients (estimated)

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Trial Locations

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California

Hoag Memorial Hospital Presbyterian

Newport Beach, CA

Open and Accepting

Florida

Sylvester Comprehensive Cancer Center University of Miami Health System

Miami, FL

Open and Accepting
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