Background:
Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.
Objective:
To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.
Eligibility:
Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).
Design:
Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body.
All participants will have 3 study visits. During each visit they will have:
Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine.
An optional magnetic resonance imaging scan.
A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.
These tests may be spread over 30 days for each visit.
NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.
All participants will have a third study visit after 5 years or when their disease progresses.
Anemia: Hemoglobin <=10 g/dL, or
Renal Failure: serum creatinine >= 2.0 mg/dL, or
Hypercalcemia: Ca >= 10.5 mg/dL, or
Lytic bone lesions on X-ray, CT, or PET/CT, or
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.
Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.