Status:
COMPLETED
Imaging in MGUS, SMM and MM
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Multiple Myeloma
Smoldering Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 progressi...
Detailed Description
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 premali...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 17 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2011
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01237054
Start Date
October 17 2010
End Date
August 9 2011
Last Update
August 14 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892