Multiple Myeloma Clinical Trial
Official title:
A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and
fludeoxyglucose F 18 positron emission tomography (^18FDG-PET) may help diagnose solitary
plasmacytoma.
PURPOSE: This clinical trial is studying MRI and ^18FDG-PET to see how well they work in
diagnosing patients with solitary plasmacytoma.
OBJECTIVES:
- Determine the proportion of patients who are misclassified as true solitary
plasmacytoma by MRI and whole-body fludeoxyglucose F 18 positron emission tomography as
a supplement to imaging with skeletal survey.
- Determine the feasibility of accruing patients to this study.
- Determine, preliminarily, biological correlates and prognostic groups that may relate
to progression to symptomatic disease in patients undergoing these imaging procedures.
- Correlate germline genetic polymorphisms with overall clinical course in patients
undergoing these imaging procedures.
OUTLINE: This is a multicenter study.
Within 28 days after study entry, patients undergo gadolinium MRI of the head, spine, and
pelvis (and other sites, if indicated). Patients then receive fludeoxyglucose F 18 IV
followed 90 minutes later by whole-body positron emission tomography (^18FDG-PET) OR
whole-body CT scan/PET. Patients with a confirmed diagnosis of solitary plasmacytoma undergo
MRI and ^18FDG-PET as above at 1 year and then annually for 10 years in the absence of
disease progression (i.e., change of status to solitary plasmacytoma with active myeloma or
biopsy confirmed stage IB or higher multiple myeloma).
After completion of study procedures, patients are followed every 6 months for 10 years.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study.
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