Multiple myeloma (MM) survival has been im­proved during the last decade owing to new treat­ments. Hence, it has become a matter of importance to precisely define the depth of MM response to ther­apy. 18F-FDG PET/CT (FDG-PET) has proved to be superior to X-rays for the initial staging of MM. It is now recommended by the Inter­na­tional Myeloma Work­ing Group (IMWG) during the initial work-up and for response evaluation, as it is superior to MRI in that setting. However, sensitivity of FDG-PET remains inferior to that of MRI for the initial staging of MM. Indeed, FDG-PET remains limited for the evaluation of skull lesions (due to brain physiological back­ground) or spine in­fil­tra­tive disease. Therefore, there is a need for a new diagnostic tool which could have equivalent sensitivity to that of MRI at diag­nosis, and could bring better base­line in­for­ma­tion than FDG PET for ther­apy evaluation. Ultimately, this tool would be a one-stop-shop exam for diag­nosis and patient follow-up during treat­ment. 18F-Choline, a tracer of phospholipids of cell membrane, has shown poten­tial as compared to 18F-FDG in a recent retro­spec­tive­ study, with about 70% more lesions detected in MM patients with sus­pected relapsing disease. Following that perspective, our main objective is to compare pro­spec­tive­ly, in a cohort of newly diag­nosed MM, the detection rate of MM lesions by 18F-Choline PET/CT (FCH-PET) vs. FDG-PET. Our sec­ond­ary objectives will be to compare the per­for­mance of both PET modalities as regard to MRI as well as the detection rate of extra-medullary lesions. Patients with MM will proceed to FCH-PET, FDG-PET and then Whole-Body MRI within 3 weeks.

Enrollment status: Not yet recruiting.
Estimated start date: May 1, 2019.

Countries with trial sites (# of sites): France (1).

Type of trial: Interventional.
Phase of trial: Phase 3.

Trial ID: NCT03891914, CHUBX 2017/32.

Additional trial in­for­ma­tion at clin­i­caltrials.gov: link.