S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00109889
• Other study ID #: CDR0000426422
• Secondary ID: U10CA032102S0340
• Status: Terminated
• Phase: Phase 2
• First received: May 3, 2005
• Last updated: April 21, 2017
• Start date: April 2005
• Est. completion date: April 2007

Study information

• Verified date: April 2017
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Plasmacytoma

Intervention

Procedure:
• magnetic resonance imaging
magnetic resonance imaging (MRI)
• positron emission tomography
positron emission tomography (PET)

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Billings Clinic Cancer Center	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Deaconess Billings Clinic - Downtown	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare	Billings	Montana
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	St. James Community Hospital	Butte	Montana
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	Big Sky Oncology	Great Falls	Montana
United States	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Wilson Medical Center	Wilson	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients misclassified as solitary plasmacytoma		2 months