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

• Status: Completed
• Trial end date: 2020-04-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Antibodies; Antibodies, Monoclonal; Daratumumab; Immunoglobulins

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.