RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI) and fludeoxyglucose F 18 positron emission tomography (18FDG-PET) may help diagnose plasmacytoma.

PURPOSE: This clinical trial is studying MRI and 18FDG-PET to see how well they work in diagnosing patients with plasmacytoma.

Condition	Treatment or Intervention
extramedullary plasmacytoma isolated plasmacytoma of bone	Drug: fludeoxyglucose F 18  Procedure: computed tomography  Procedure: diagnostic test  Procedure: magnetic resonance imaging  Procedure: tomography, emission computed

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solitary plasmacytoma of 1 of the following types:
• Solitary bone plasmacytoma
• Extraosseus solitary plasmacytoma
• Bone marrow plasmacytosis < 10% within the past 4 weeks
• 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
• 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 provided radiotherapy was initiated within the past 84 days
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00109889

Study chairs or principal investigators

Andrzej J. Jakubowiak, MD,  Study Chair,  University of Michigan Comprehensive Cancer Center   
J. Sybil Biermann, MD,  University of Michigan Comprehensive Cancer Center   
Paul Okunieff, MD,  James P. Wilmot Cancer Center   

Study ID Numbers:  CDR0000426422; SWOG-S0340; NCT00109889
Record last reviewed:  May 2005
Last Updated:  May 11, 2005
Record first received:  May 3, 2005
ClinicalTrials.gov Identifier:  NCT00109889
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17