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A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma, Plasmacytoma

Thank you

Trial Information

A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

proportion of patients misclassified as solitary plasmacytoma

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Andrzej J. Jakubowiak, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000426422

NCT ID:

NCT00109889

Start Date:

April 2005

Completion Date:

February 2017

Related Keywords:

  • Multiple Myeloma
  • Plasmacytoma
  • extramedullary plasmacytoma
  • isolated plasmacytoma of bone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804