S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

This study has been terminated.
(poor accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00109889
First received: May 3, 2005
Last updated: April 2, 2012
Last verified: April 2012

May 3, 2005
April 2, 2012
April 2005
April 2007   (final data collection date for primary outcome measure)
proportion of patients misclassified as solitary plasmacytoma [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00109889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
  • Multiple Myeloma
  • Plasmacytoma
  • Procedure: magnetic resonance imaging
    magnetic resonance imaging (MRI)
    Other Name: MRI
  • Procedure: positron emission tomography
    positron emission tomography (PET)
    Other Name: PET
MRI and PET
Magnetic resonance imaging and positron emission tomography
Interventions:
  • Procedure: magnetic resonance imaging
  • Procedure: positron emission tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
February 2017
April 2007   (final data collection date for primary outcome measure)

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
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00109889
CDR0000426422, U10CA032102, S0340
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Andrzej J. Jakubowiak, MD, PhD University of Michigan Cancer Center
Study Chair: Janet S. Biermann, MD University of Michigan Cancer Center
Study Chair: Paul Okunieff, MD James P. Wilmot Cancer Center
Southwest Oncology Group
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP