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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04814615.
This will be a phase II clinical trial to assess the potential clinical value of
89Zr-DFO-daratumumab immunoPET. 60 patients with multiple myeloma (MM) and a plan for
daratumumab containing combination therapy will be enrolled. Prior to therapy, current
standard of care (SoC), as well as a research 89Zr-DFO-daratumumab PET/CT, tests will be
performed. Patients will then undergo standard of care therapy for myeloma as defined by
a medical oncologist and SoC response assessments as defined by the International Myeloma
Working Group (IMWG). Upon suspected complete response (CR) or completion of 12 cycles of
therapy, a repeat research 89Zr-DFO-daratumumab PET/CT will be repeated and standard of
care minimal residual disease (MRD) assessment will be performed. This design will
determine how 89Zr-DFO-daratumumab immunoPET compares with current methods of measuring
and localizing disease prior to therapy, if immunoPET can predict response to therapy,
and how immunoPET compares with current methods of detecting MRD after therapy.
The therapy in this trial is standard of care. The research component is the addition of
a novel immunoPET imaging test before and after standard of care therapy, to determine if
the novel imaging test adds value over current measures of myeloma disease burden.
Lead OrganizationHoag Memorial Hospital Presbyterian
