First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody

Completed · Phase 1/Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT03665155

Run by

Memorial Sloan Kettering Cancer Center

People needed

11

Starts

2018-09-05

Expected to finish

2020-04-20

Last updated by the study team

2021-07-30

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21 years or greater
• Histologically/Immunohistochemistry confirmed CD38-positive multiple myeloma
• At least one tumor lesion on CT, MRI, or FDG PET/CT within 60 days of protocol enrollment
• ECOG performance status 0 to 2
• For Phase II patients only: plan for initiation of standard-of-care daratumumab/lenalidomide therapy.

You may not qualify if…

• Life expectancy < 3 months
• Pregnancy or lactation
• 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 or a Grade 3 or 4 administration reaction during a daratumumab administration.

Where it is running

• Memorial Slaon-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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