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Clinical Trial · NCT03665155
First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
Overview
The purpose of this study is to test 89Zr-DFO-daratumumab, a new imaging agent, to demonstrate its safety and ability to take pictures of the myeloma.
Sponsor
Memorial Sloan Kettering Cancer Center
Phase
Phase 1/2
Contacts
Gary Ulaner, MD, PhD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03665155Eligibility
Inclusion
- ECOG performance status 0 to 2
- At least one tumor lesion on CT, MRI, or FDG PET/CT within 60 days of protocol enrollment
- Histologically/Immunohistochemistry confirmed CD38-positive multiple myeloma
- For Phase II patients only: plan for initiation of standard-of-care daratumumab/lenalidomide therapy.
Exclusion
- Pregnancy or lactation
- Life expectancy \< 3 months
- History of anaphylactic reaction to humanized or human antibodies or a Grade 3 or 4 administration reaction during a daratumumab administration.
- 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.
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