Last updated on January 2019

Copper 64Cu-DOTA-Daratumumab Positron Emission Tomography in Diagnosing Patients With Relapsed Multiple Myeloma


Brief description of study

This pilot phase I clinical trial studies how well copper 64Cu-DOTA-daratumumab positron emission tomography works in diagnosing patients with multiple myeloma that has come back. Diagnostic procedures, such as copper 64Cu-DOTA-daratumumab positron emission tomography, may help evaluate the extent of multiple myeloma in patients prior to the initiation of treatment and ultimately monitor disease status/response during and post treatment.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess safety and tolerability of unlabeled daratumumab followed by 64Cu-DOTA-daratumumab positron emission tomography, at each dose level, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.

SECONDARY OBJECTIVES:

I. Generate initial estimates of the biodistribution of the 64Cu-DOTA-daratumumab and the preferred dose of cold antibody.

II. Determine the dose of pre-administered unlabeled daratumumab that optimizes image quality of 64Cu-anti-CD38 (daratumumab)-NHS-DOTA.

III. Evaluate the sensitivity of 64Cu-anti-CD38 (daratumumab)-NHS-DOTA in detecting lesions compared to 18F fludeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) scanning.

OUTLINE

Patients receive daratumumab intravenously (IV) over 10-45 minutes, and within 6 hours, patients receive copper 64Cu-DOTA-daratumumab IV on day 0. Patients undergo PET on days 1 and 2.

After completion of study, patients are followed up for 7 days and then at 2 weeks.

Clinical Study Identifier: NCT03311828

Contact Investigators or Research Sites near you

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Amrita Krishnan, MD

City of Hope Medical Center
Duarte, CA United States
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Recruitment Status: Open


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