Imaging in MGUS, SMM and MM
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2010 |
| End Date: | August 2011 |
A Pilot Study of Novel Imaging Modalities in Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), and Multiple Myeloma (MM)
Background:
- Recent studies have shown that the premalignant conditions monoclonal gammopathy of
undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of
progressing to multiple myeloma (MM). There are currently no known effective treatments to
prevent MGUS or SMM from developing into MM, and there are no known tests for determining
whether an individual with MGUS or SMM will develop MM. Researchers are investigating new
and improved imaging techniques that may be able to better detect the progression of MGUS or
SMM into MM.
Objectives:
- To compare the results of three imaging techniques in individuals with MGUS, SMM, and
MM.
- To correlate the information from the imaging studies with established clinical markers
of progression from MGUS/SMM to MM.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with monoclonal gammopathy of
undetermined significance, smoldering multiple myeloma, or multiple myeloma.
Design:
- Participants will be screened with a physical examination and medical history, and will
provide baseline blood, urine, and bone marrow samples before beginning the imaging
studies.
- Participants will have three imaging studies on separate days: a standard
18-fludeoxyglucose positron emission tomography/computed tomography scan (18-FDG
PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT),
and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
- Participants will be closely monitored during each scan, and will provide additional
blood samples before and after the scans.
- Participants may provide additional blood, urine, tissue, and bone marrow samples for
optional research studies.
- Recent studies have shown that the premalignant conditions monoclonal gammopathy of
undetermined significance (MGUS) and smoldering multiple myeloma (SMM) have a high risk of
progressing to multiple myeloma (MM). There are currently no known effective treatments to
prevent MGUS or SMM from developing into MM, and there are no known tests for determining
whether an individual with MGUS or SMM will develop MM. Researchers are investigating new
and improved imaging techniques that may be able to better detect the progression of MGUS or
SMM into MM.
Objectives:
- To compare the results of three imaging techniques in individuals with MGUS, SMM, and
MM.
- To correlate the information from the imaging studies with established clinical markers
of progression from MGUS/SMM to MM.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with monoclonal gammopathy of
undetermined significance, smoldering multiple myeloma, or multiple myeloma.
Design:
- Participants will be screened with a physical examination and medical history, and will
provide baseline blood, urine, and bone marrow samples before beginning the imaging
studies.
- Participants will have three imaging studies on separate days: a standard
18-fludeoxyglucose positron emission tomography/computed tomography scan (18-FDG
PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT),
and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI).
- Participants will be closely monitored during each scan, and will provide additional
blood samples before and after the scans.
- Participants may provide additional blood, urine, tissue, and bone marrow samples for
optional research studies.
Background:
- Multiple myeloma (MM) is a plasma cell neoplasm with a median survival of 3-4 years.
- Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM)
are premalignant plasma cell proliferative disorders characterized by elevated
monoclonal protein and bone marrow plasma cells. MGUS affects 3.2% of Caucasians over
the age of 50 and has a 1% annual risk of progression to MM.
Approximately 3000 cases of SMM are diagnosed annually with a 10% annual risk of progression
to MM.
- Currently, it is not possible to predict which patients will progress to MM.
- Novel imaging modalities (FDG-PET, 18-NaF PET and DCE-MRI) may improve our ability to
predict patients who are at high risk of progression.
Objectives:
- To compare the results of imaging modalities (18-NaF PET/CT, 18-FDG PET/CT, and
DCE-MRI) in patients with MGUS, SMM, and MM.
- To correlate the imaging studies with established clinical markers of progression from
MGUS/SMM to MM, including serum M-protein, percentage of plasma cells in the bone
marrow, serum free light-chain abnormalities and immunoparesis, and ratio of
normal/abnormal plasma cells in the bone marrow by flow cytometry.
Eligibility:
- A confirmed diagnosis of MGUS, SMM or MM (based on IMWG (International Myeloma Working
Group) diagnostic criteria)
- Age greater than or equal to 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status in the range of 0-2
Design:
- This is a cross-sectional pilot study of patients with MGUS, SMM or MM.
- Following initial evaluation and confirmation of diagnosis, baseline studies including
skeletal survey will be done.
- Subsequently 18-NaF PET/CT, 18-FDG PET/CT and DCE-MRI imaging will be done in all the
patients.
- 10 MGUS, 11 SMM and 10 MM patients will be enrolled on this protocol.
- Patients may donate cellular products or tissues as appropriate for research purposes.
- Almost all MGUS and SMM patients will be followed clinically as part of 10-C-0096:
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and
Smoldering Myeloma (SMM).
- Multiple myeloma (MM) is a plasma cell neoplasm with a median survival of 3-4 years.
- Monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM)
are premalignant plasma cell proliferative disorders characterized by elevated
monoclonal protein and bone marrow plasma cells. MGUS affects 3.2% of Caucasians over
the age of 50 and has a 1% annual risk of progression to MM.
Approximately 3000 cases of SMM are diagnosed annually with a 10% annual risk of progression
to MM.
- Currently, it is not possible to predict which patients will progress to MM.
- Novel imaging modalities (FDG-PET, 18-NaF PET and DCE-MRI) may improve our ability to
predict patients who are at high risk of progression.
Objectives:
- To compare the results of imaging modalities (18-NaF PET/CT, 18-FDG PET/CT, and
DCE-MRI) in patients with MGUS, SMM, and MM.
- To correlate the imaging studies with established clinical markers of progression from
MGUS/SMM to MM, including serum M-protein, percentage of plasma cells in the bone
marrow, serum free light-chain abnormalities and immunoparesis, and ratio of
normal/abnormal plasma cells in the bone marrow by flow cytometry.
Eligibility:
- A confirmed diagnosis of MGUS, SMM or MM (based on IMWG (International Myeloma Working
Group) diagnostic criteria)
- Age greater than or equal to 18 years
- ECOG (Eastern Cooperative Oncology Group) performance status in the range of 0-2
Design:
- This is a cross-sectional pilot study of patients with MGUS, SMM or MM.
- Following initial evaluation and confirmation of diagnosis, baseline studies including
skeletal survey will be done.
- Subsequently 18-NaF PET/CT, 18-FDG PET/CT and DCE-MRI imaging will be done in all the
patients.
- 10 MGUS, 11 SMM and 10 MM patients will be enrolled on this protocol.
- Patients may donate cellular products or tissues as appropriate for research purposes.
- Almost all MGUS and SMM patients will be followed clinically as part of 10-C-0096:
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and
Smoldering Myeloma (SMM).
- INCLUSION CRITERIA:
- Diagnosis of MGUS, SMM and MM will be made in accordance with the clinical diagnostic
criteria set forth by the International Myeloma Working Group.2. The diagnoses will
be confirmed by laboratory tests, serum/urine protein electrophoresis, immunofixation
and light-chain assays, a skeletal survey, or immunohistochemistry analyses of the
bone marrow biopsy, or a combination of these.
- Age greater than or equal to 18 years.
- ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
- The patient must be competent to sign an informed consent form.
- Creatinine less than 2.5 ULN or eGFR (estimated glomerular filtration rate) greater
than 30
EXCLUSION CRITERIA:
- A medical history of other malignancy (apart from basal cell carcinoma of the skin or
in situ cervical carcinoma; also, for MM patients this does not include MM) except if
the patient has been free of symptoms and without active therapy during at least the
previous 5 years.
- Female subject is pregnant or breast-feeding.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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