Multiple MyelomaPhase 2NCT00109889
S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
A Phase 2 study testing magnetic resonance imaging and positron emission tomography in people with Multiple Myeloma and Plasmacytoma, run by SWOG Cancer Research Network at 26 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Multiple Myeloma, Plasmacytoma
- What is being tested?
- magnetic resonance imaging and positron emission tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 26 sitesUnited States
- Study dates
- Apr 2005to Apr 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
St. Vincent Healthcare
Billings, Montana, 59101
Billings Clinic Cancer Center
Billings, Montana, 59107-5100
Deaconess Billings Clinic - Downtown
Billings, Montana, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
St. James Community Hospital
Butte, Montana, 59701
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Wayne Radiation Oncology
Goldsboro, North Carolina, 27534
Big Sky Oncology
Great Falls, Montana, 59405
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405
St. Peter's Hospital
Helena, Montana, 59601
Glacier Oncology, PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology
Kalispell, Montana, 59901
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Community Medical Center
Missoula, Montana, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807
Mobile Infirmary Medical Center
Mobile, Alabama, 36652-2144
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, 67401
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801
Wilson Medical Center
Wilson, North Carolina, 27893-3428
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma, Plasmacytoma
- Being tested
- magnetic resonance imaging, positron emission tomography
- Keywords
- extramedullary plasmacytoma, isolated plasmacytoma of bone
- Medical subject headings
- Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
Also called MRI
magnetic resonance imaging (MRI)
positron emission tomographyProcedure or surgery
Also called PET
positron emission tomography (PET)
| Study group | Role | What they receive |
|---|---|---|
| MRI and PET | Other | Magnetic resonance imaging and positron emission tomography Receives: Procedure: magnetic resonance imaging; Procedure: positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients misclassified as solitary plasmacytoma
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrzej J. Jakubowiak, MD, PhD, Study chair, University of Michigan Rogel Cancer CenterJanet S. Biermann, MD, Study chair, University of Michigan Rogel Cancer CenterPaul Okunieff, MD, Study chair, James P. Wilmot Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109889
- Sponsor's protocol ID
- CDR0000426422
- Other IDs
- U10CA032102, S0340
- Status last verified
- Apr 2017
- First submitted
- 3 May 2005
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00109889
- Acronym / sponsor ID
- CDR0000426422
- Conditions
- Multiple Myeloma, Plasmacytoma
- Keywords
- extramedullary plasmacytoma, isolated plasmacytoma of bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 4 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI and PET | Other | Procedure: magnetic resonance imaging, Procedure: positron emission tomographyMagnetic resonance imaging and positron emission tomography |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetic resonance imagingAlso: MRImagnetic resonance imaging (MRI) | Procedure or surgery | MRI and PET |
| positron emission tomographyAlso: PETpositron emission tomography (PET) | Procedure or surgery | MRI and PET |
Primary outcome
proportion of patients misclassified as solitary plasmacytoma
Time frame: 2 months
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej J. Jakubowiak, MD, PhD study chair
University of Michigan Rogel Cancer Center
Janet S. Biermann, MD study chair
University of Michigan Rogel Cancer Center
Paul Okunieff, MD study chair
James P. Wilmot Cancer Center
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing magnetic resonance imaging and positron emission tomography in people with Multiple Myeloma and Plasmacytoma, run by SWOG Cancer Research Network at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients misclassified as solitary plasmacytoma (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.