Imaging in MGUS, SMM and MM

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01237054
First received: November 6, 2010
Last updated: June 14, 2014
Last verified: April 2014

November 6, 2010
June 14, 2014
October 2010
August 2011   (final data collection date for primary outcome measure)
  • Compare the results of three imaging techniques in individuals withMGUS, SMM, and MM. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • To correlate the imaging studies with established clinical markers ofprogression 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... [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01237054 on ClinicalTrials.gov Archive Site
1.1.2.1 To explore results from the imaging studies in relation to molecular profiles (including gene expression profiling and other biologic and molecular markers) of MM and its precursor states. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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Imaging in MGUS, SMM and MM
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 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 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 diagnostic criteria)
  • Age greater than or equal to 18 years
  • ECOG 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).

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Multiple Myeloma
  • Smoldering Multiple Myeloma
  • Monoclonal Gammopathy of Undetermined Significance
  • Drug: 18-NaF PET
    The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection.
  • Other: DCE-MRI
    An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).
  • Drug: 18-FDG PET/CT
    The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. The injection site will be evaluated pre- and post administration for any reaction (e.g. bleeding, hematoma, redness, or infection). Whole body (vertex to toes) static PET/CT imaging will be performed beginning at 1-hour, and again at 2-hours post injection.
Experimental: A
Participants will have three imaging studies on separate days: a standard 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 magnetic resonance imaging (DCE-MRI).
Interventions:
  • Drug: 18-NaF PET
  • Other: DCE-MRI
  • Drug: 18-FDG PET/CT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
August 2011
August 2011   (final data collection date for primary outcome measure)
  • 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 performance status of 0-2.
  • The patient must be competent to sign an informed consent form.
  • Creatinine less than 2.5 ULN or eGFR 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01237054
110020, 11-C-0020
Not Provided
Not Provided
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Peter L Choyke, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP