S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
Status and phase
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Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed solitary plasmacytoma of 1 of the following types:
- Solitary bone plasmacytoma
- Extraosseus solitary plasmacytoma
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Bone marrow plasmacytosis < 10% within the past 4 weeks
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Low serum and/or urine M-protein meeting ≥ 1 of the following criteria:
- Serum IgG < 3.5 g/dL
- Serum IgA < 2.0 g/dL
- Urine M-protein (kappa or lambda) < 1.0 g/24 hours
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No lytic lesions on skeletal survey other than a single lesion associated with solitary plasmacytoma within the past 4 weeks
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 10 g/dL* AND/OR
- No hemoglobin 2 g/dL < lower limit of normal* (LLN) NOTE: *Patients with a history of hemoglobin < 10 g/dL AND/OR < 2 g/dL < LLN that has corrected or improved after epoetin alfa but requires continued treatment with epoetin alfa are not eligible
Hepatic
- Not specified
Renal
- Calcium ≤ 10.5 mg/dL OR
- Calcium normal
- Creatinine ≤ 2 mg/dL
Other
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, or stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No prior high-dose steroids except to relieve neurological compromise
Radiotherapy
- Prior localized radiotherapy for myeloma allowed
- Concurrent radiotherapy allowed
Surgery
- Prior surgery for myeloma allowed
Other
- No other prior therapy for myeloma
- Concurrent enrollment in protocol SWOG-S0309 (Myeloma Specimen Repository) allowed
Trial design
Primary purpose
Allocation
Interventional model
Masking
2 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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