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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Multiple Myeloma

Treatments: Device: PET/CT scans; Drug: 89Zr-daratumumab; Other: Blood draws

Study type: Interventional

Funder types: Other

Identifiers

NCT03665155

18-267

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

89Zr-daratumumab

Experimental group

Description:

Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality. Patients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients). After pharmacokinetics and radiation dosimetry are determined in phase I, additional patients will be enrolled in phase II.

Treatment:

Other: Blood draws

Device: PET/CT scans

Drug: 89Zr-daratumumab