Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
Evaluation of myeloma disease burden is currently suboptimal. This limits treatment planning
and evaluation of residual disease following treatment. 89Zr-DFO-daratumumab is a novel
immunoPET tracer, designed to detect CD38 on myeloma cells and allow visualization of myeloma
in a PET scanner. A phase I study of 89Zr-DFO-daratumumab demonstrated safety and successful
visualization of myeloma with 89Zr-DFO-daratumumab. This will be a phase II study of
89Zr-DFO-daratumumab to evaluate potential clinical applications of this novel imaging agent.
Phase
Phase 2
Funding Agency/Sponsor
Externally Peer-Reviewed
Disease
Myeloma
Enrollment Eligibility
Inclusion Criteria:
1. Male or female ≥ 21 years of age
2. Histologically/immunohistochemistry-confirmed CD38-positive multiple myeloma
3. At least one tumor lesion on CT, MRI, or FDG PET/CT within 90 days of protocol
enrollment
4. ECOG performance status 0 to 2
5. Written informed consent obtained from subject or subject's legal representative and
ability for subject to comply with the requirements of the study
Exclusion Criteria:
1. Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study.
2. Life expectancy < 12 months
3. 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.
4. History of anaphylactic reaction to humanized or human antibodies.