Imaging in MGUS, SMM and MM

• Status: Completed
• Trial end date: 2011-08-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorodeoxyglucose F18

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 (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.