A Diagnostic Study of CD38-Targeted ImmunoPET of Myeloma

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.