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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665155
• Other study ID #: 18-267
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 5, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: April 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Device:
• PET/CT scans
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.

Other:
• Blood draws
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,

Locations

Country	Name	City	State
United States	Memorial Slaon-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 19 months

External Links

•   Memorial Sloan Kettering Cancer Center