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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04467281

Enrollment

Registered

2020-07-13

Start date

2020-06-30

Completion date

2021-02-26

Last updated

2022-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

CD38-Targeted ImmunoPET, 20-098

Brief 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.

Interventions

DRUG89Zr-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_TESTPET/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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

This will be a phase II clinical trial.

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
number of patient's with positive tumors	1 year	Uptake of FDG PET/CT

Secondary

Measure	Time frame	Description
assess if tumor uptake of 89Zr-DFO-daratumumab predicts response to daratumumab/lenalidomide therapy	1 year	The response will be defined using IMWG criteria as complete or partial response; stable disease and progressive disease will be considered as non-response.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026