First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/19/2019 |
| Start Date: | September 5, 2018 |
| End Date: | September 2021 |
| Contact: | Gary Ulaner, MD, PhD |
| Email: | ulanerg@mskcc.org |
| Phone: | 646-888-4554 |
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.
demonstrate its safety and ability to take pictures of the myeloma.
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.
We found this trial at
1
site
205 East 64th Street
New York, New York 10065
New York, New York 10065
Principal Investigator: Gary Ulaner, MD, Ph.D.
Phone: 212-639-3776
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