Phase 2 Evaluation of 18F-Fluciclovine PETCT Imaging to Detect Multiple Myeloma in Adults

What this Trial Is About

Multiple myeloma MM is a type of blood cancer that currently has no cure and often returns after treatment, leading to a survival time of about 5 to 8 years after diagnosis. Researchers are studying whether a new imaging substance called 18F-fluciclovine can detect MM more effectively than the currently used 18F-FDG. This trial is a phase 2 study focused on adults with MM, including those newly diagnosed or with relapsedrefractory disease, aiming to improve early detection of returning disease. Participants will receive an injection of the radiotracer 18F-fluciclovine and undergo PETCT scans at three different times initially, after treatment for newly diagnosed participants or six months for relapsedrefractory participants, and at disease progression or after 5 years. Each visit includes two PETCT scansone with 18F-FDG and one with 18F-fluciclovineas well as an optional MRI scan and a bone marrow biopsy. The study compares the imaging results from both tracers to assess which better detects MM lesions. During the study, participants will attend three visits where tests and scans will be performed, possibly spread over 30 days per visit. Blood tests, imaging scans, and bone marrow samples will help researchers measure disease volume, minimal residual disease, and response to treatment. Safety of the new radiotracer is also monitored shortly after each dose. Participation may last up to 5 years, with follow-up visits scheduled to track disease progression and imaging results.

18F-Fluciclovine PET/CT in Multiple Myeloma