NCT00109889

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

26 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

May 3, 2005

Last Update Submit

April 21, 2017

Conditions

Multiple MyelomaPlasmacytoma

Keywords

extramedullary plasmacytomaisolated plasmacytoma of bone

Outcome Measures

Primary Outcomes (1)

  • proportion of patients misclassified as solitary plasmacytoma

    2 months

Study Arms (1)

MRI and PET

OTHER

Magnetic resonance imaging and positron emission tomography

Procedure: magnetic resonance imagingProcedure: positron emission tomography

Interventions

magnetic resonance imagingPROCEDURE

magnetic resonance imaging (MRI)

Also known as: MRI
MRI and PET
positron emission tomographyPROCEDURE

positron emission tomography (PET)

Also known as: PET
MRI and PET

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (26)

Mobile Infirmary Medical Center

Mobile, Alabama, 36652-2144, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Multiple MyelomaPlasmacytoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Andrzej J. Jakubowiak, MD, PhD

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

  • Janet S. Biermann, MD

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

  • Paul Okunieff, MD

    James P. Wilmot Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

April 1, 2005

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

US(26)