Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)
Stopped early
Conditions studied: Smoldering Myeloma, Monoclonal Gammopathy of Undetermined Significance
In brief
Background: \- Multiple myeloma is a type of cancer that affects white blood cells and has a poor long-term survival rate. Two other types of cancer, monoclonal gammopathy of undetermined significance (MGUS) and smoldering myeloma (SMM), may eventually progress and develop into multiple myeloma. Researchers are interested in collecting samples from individuals who have been diagnosed with MGUS and SMM to study possible risk factors for developing multiple myeloma. Objectives: \- To study risk factors that may cause MGUS and SMM to progress to multiple myeloma. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with either MGUS or SMM but do not have multiple myeloma. Design: * Participants will be examined by study researchers at the initial visit, at 6 months following enrollment, and every 12 months for a maximum of 5 years. * The following tests may be performed: (1) blood and urine tests, (2) bone marrow aspiration and biopsy, (3) imaging studies, and (4) a skeletal survey (a series of skeletal X-rays of the skull, spine, pelvis, ribs, shoulders, upper arm, and thigh bones). * Treatment will not be provided as part of this protocol. - Participants will remain on the study for 5 years, or until their MGUS or SMM progresses to multiple myeloma requiring treatment.
Key facts
- Study ID
- NCT01109407
- Run by
- National Cancer Institute (NCI)
- People needed
- 225
- Starts
- 2010-04-22
- Expected to finish
- 2021-02-25
- Last updated by the study team
- 2021-03-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- A diagnosis of MM as defined as any patient with detectable M-protein in blood and/or urine, monoclonal plasma cells in the bone marrow, and evidence of end-organ damage (based on the International Myeloma Working Group s diagnostic CRAB criteria:
- hypercalcemia [serum calcium at least 1 mg/dL above the upper limit of normal], renal failure [creatinine greater than 1.95 mg/dL), anemia (hemoglobin less than 10 g/dL], or bone lesions [lytic lesions or osteoporosis with compression fractures]).
- Patients who have received previous therapy for MM.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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