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

Memorial Sloan Kettering Cancer Center11 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

89Zr-daratumumabDRUG

2 mCi of 89Zr-daratumumab will be administered on day 0.

PET/CT scansDEVICE

PET/CT images will be obtained on post-administration days 1, 2-4, 5-6, and/or 7-8 following administration of 89Zr-DFO-daratumumab to determine the optimal time point for imaging.

Blood drawsOTHER

Blood and serum samples will be weighed and counted in a scintillation well counter calibrated for 89Zr. Immediately before or after each PET/CT imaging session,

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (1)

Memorial Slaon-Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants

Standardized uptake value (SUV) in various organs will be estimated from VOI analysis of clinical images and converted to activity-time curves. The areas under the activity-time curves will be derived by integration, converted to residence times, and used as input to the OLINDA/EXM dosimetry program to obtain absorbed dose estimates for normal tissues for all Phase I participants, regardless of study dose. Each participant underwent four PET/CT scans over the next 8 days, as well as blood chemistry and whole-body counts, to determine safety, tracer biodistribution, pharmacokinetics, and radiation dosimetry. Because 89Zr has a half-life of 78 hours, only a single administration of tracer was needed to obtain all four PET/CT scans for all Phase I participants. Results were combined because all received the same dose of tracer.

Time frame: up to 19 months

Data from ClinicalTrials.gov

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