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NCT04467281 Clinical Trial

A Study of PET/CT Scans With the Radioactive Tracer 89Zr-DFO-Daratumumab in People With Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04467281
Other study ID # 20-098
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date June 30, 2020
Est. completion date February 26, 2021

Study information
Verified date June 2022
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 see if using the radioactive tracer 89Zr-DFO-daratumumab with PET/CT scans is a practical and effective way to view and monitor multiple myeloma in participants before and during their treatment with daratumumab. We also want to see if 89Zr-DFO-daratumumab PET/CT scans can predict a participant's response to therapy, and if they can better locate any leftover disease following treatment compared to the standard imaging methods.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 26, 2021
Est. primary completion date February 26, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Age = 21 years - Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma - At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol enrollment - ECOG performance status 0 to 2 - Participant is capable of having an informed consent discussion (Legally Authorized Representatives are not permitted to sign on a participant's behalf). Exclusion Criteria: - Life expectancy < 12 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. - Previous treatment with daratumumab. Previous treatment with other myeloma therapies will be allowed.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 89Zr-DFO-daratumumab
Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.
Diagnostic Test:
• PET/CT
Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Outcome
Type Measure Description Time frame Safety issue
Primary number of patient's with positive tumors Uptake of FDG PET/CT 1 year
Secondary assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response. 1 year
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