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A Pilot Study of Novel Imaging Modalities in Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), and Multiple Myeloma (MM)


N/A
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma, Smoldering Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance

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Trial Information

A Pilot Study of Novel Imaging Modalities in Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), and Multiple Myeloma (MM)


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).

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Carl O Landgren, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

110020

NCT ID:

NCT01237054

Start Date:

October 2010

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Smoldering Multiple Myeloma
  • Monoclonal Gammopathy of Undetermined Significance
  • 18-FDG PET/CT
  • Abnormal Plasma Cells
  • Serum Free Light-Chain Abnormality
  • Serum M-Protein
  • DCE-MRI
  • Multiple Myeloma
  • Smoldering Multiple Myeloma
  • SMM
  • MM
  • Monoclonal Gammopathy of Undetermined Significance
  • Paraproteinemias
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892