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S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

Primary Purpose

Multiple Myeloma, Plasmacytoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance imaging
positron emission tomography
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma focused on measuring extramedullary plasmacytoma, isolated plasmacytoma of bone

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mobile Infirmary Medical Center
  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Tammy Walker Cancer Center at Salina Regional Health Center
  • University of Michigan Comprehensive Cancer Center
  • CCOP - Montana Cancer Consortium
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare
  • Billings Clinic Cancer Center
  • Deaconess Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • St. James Community Hospital
  • Big Sky Oncology
  • Sletten Regional Cancer Institute at Benefis Healthcare
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Community Medical Center
  • Guardian Oncology and Center for Wellness
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Wayne Memorial Hospital, Incorporated
  • Wayne Radiation Oncology
  • Wilson Medical Center
  • Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MRI and PET

Arm Description

Magnetic resonance imaging and positron emission tomography

Outcomes

Primary Outcome Measures

proportion of patients misclassified as solitary plasmacytoma

Secondary Outcome Measures

Full Information

First Posted
May 3, 2005
Last Updated
April 21, 2017
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00109889
Brief Title
S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
poor accrual
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Plasmacytoma
Keywords
extramedullary plasmacytoma, isolated plasmacytoma of bone

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI and PET
Arm Type
Other
Arm Description
Magnetic resonance imaging and positron emission tomography
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
magnetic resonance imaging (MRI)
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
PET
Intervention Description
positron emission tomography (PET)
Primary Outcome Measure Information:
Title
proportion of patients misclassified as solitary plasmacytoma
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej J. Jakubowiak, MD, PhD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Janet S. Biermann, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Paul Okunieff, MD
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Tammy Walker Cancer Center at Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-5100
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Community Hospital
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Regional Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Radiation Oncology
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wilson Medical Center
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893-3428
Country
United States
Facility Name
Welch Cancer Center at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

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S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma

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