A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma: Phase 2 Trial of Clinical Applications
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.
• Male or female ≥ 21 years of age
• 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
• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study