A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma

• Status: Withdrawn
• Trial end date: 2021-02-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if using the radioactive tracer 89Zr-DFO-daratumumab with PET/CT scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. We also want to see if 89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if they can better locate any leftover disease following treatment compared to the standard imaging methods.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Daratumumab

Criteria

Inclusion Criteria:

• Age ≥ 21 years

• 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

• Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf).

Exclusion Criteria:

• Life expectancy < 12 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.

• Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.