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
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Plasmacytoma
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • proportion of patients misclassified as solitary plasmacytoma [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: April 2005
Estimated Study Completion Date: February 2017
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MRI and PET
Magnetic resonance imaging and positron emission tomography
Procedure: magnetic resonance imaging
magnetic resonance imaging (MRI)
Other Name: MRI
Procedure: positron emission tomography
positron emission tomography (PET)
Other Name: PET

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109889

Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Kansas
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, Montana
St. Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Community Hospital
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59801
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
Investigators
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
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00109889     History of Changes
Other Study ID Numbers: CDR0000426422, U10CA032102, S0340
Study First Received: May 3, 2005
Last Updated: April 2, 2012
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
extramedullary plasmacytoma
isolated plasmacytoma of bone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014