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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03665155
Other study ID # 18-267
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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