A Pilot Study of Novel Imaging Modalities in Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), and Multiple Myeloma (MM)
- Multiple myeloma (MM) is a plasma cell neoplasm with a median survival of 3-4 years.
- Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM)
are premalignant plasma cell proliferative disorders characterized by elevated
monoclonal protein and bone marrow plasma cells. MGUS affects 3.2% of Caucasians over
the age of 50 and has a 1% annual risk of progression to MM.
Approximately 3000 cases of SMM are diagnosed annually with a 10% annual risk of progression
- Currently, it is not possible to predict which patients will progress to MM.
- Novel imaging modalities (FDG-PET, 18-NaF PET and DCE-MRI) may improve our ability to
predict patients who are at high risk of progression.
- To compare the results of imaging modalities (18-NaF PET/CT, 18-FDG PET/CT, and
DCE-MRI) in patients with MGUS, SMM, and MM.
- To correlate the imaging studies with established clinical markers of progression from
MGUS/SMM to MM, including serum M-protein, percentage of plasma cells in the bone
marrow, serum free light-chain abnormalities and immunoparesis, and ratio of
normal/abnormal plasma cells in the bone marrow by flow cytometry.
- A confirmed diagnosis of MGUS, SMM or MM (based on IMWG diagnostic criteria)
- Age greater than or equal to 18 years
- ECOG performance status in the range of 0-2
- This is a cross-sectional pilot study of patients with MGUS, SMM or MM.
- Following initial evaluation and confirmation of diagnosis, baseline studies including
skeletal survey will be done.
- Subsequently 18-NaF PET/CT, 18-FDG PET/CT and DCE-MRI imaging will be done in all the
- 10 MGUS, 11 SMM and 10 MM patients will be enrolled on this protocol.
- Patients may donate cellular products or tissues as appropriate for research purposes.
- Almost all MGUS and SMM patients will be followed clinically as part of 10-C-0096:
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and
Smoldering Myeloma (SMM).
Time Perspective: Prospective
Carl O Landgren, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|