Phase 2
Completed N=11
First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
Source: ClinicalTrials.gov NCT03665155 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Jul 2021
Primary outcomePrimary: Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants — 0.49 mSv/MBq
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Absorbed Radiation Dose Estimates for Normal Tissues for Phase I Participants |
0.49 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03665155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.