NCT03311828

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

A Pilot/Feasibility Trial of 64Cu-DOTA-Daratumumab Positron Emission Tomography in Patients With Newly Diagnosed or Relapsed Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Recurrent Plasma Cell Myeloma
• Plasma Cell Myeloma
• Secondary Amyloidosis

Interventions

Type	Name	Description
BIOLOGICAL	Daratumumab	Given IV
DRUG	Imaging Agent	Given Copper 64Cu-DOTA-daratumumab IV
PROCEDURE	Positron Emission Tomography	Undergo PET
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2018-02-21
• Primary completion: 2020-01-22
• Completion: 2023-06-05
• First posted: 2017-10-17
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study