Study Stopped
PI Left before primary outcome was established
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM)
2 other identifiers
observational
225
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedStudy Start
First participant enrolled
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2021
CompletedMarch 8, 2021
March 1, 2021
4.1 years
April 22, 2010
March 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Characterize the natural history and prognosis of MGUS and SMM
determination of subtypes of MM based on GEP, and determination of prognostic indicators
6 months
Integrate protein markers with molecular profiles and clinical outcomes.
comparison of molecular profiles and rate of disease progression per MM subtype
6 months
Study Arms (1)
patients with MGUS or SMM
patients with either Monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SMM)
Eligibility Criteria
Patients with MGUS or SMM will enroll on the study for the purpose of expert monitoring of their disease (MGUS or SMM), improved risk-stratification, and for the purpose of donating tissue and cellular products for research.@@@
You may qualify if:
- Diagnosis of MGUS and SMM will be made in accordance with the clinical diagnostic criteria set forth by the International Myeloma Working Group (Table 1).
- The diagnoses will be confirmed by either serum/urine protein electrophoresis, immunofixation and light-chain assays; or immunohistochemistry analyses of the bone marrow biopsy, or a combination of these tests.
- 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.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Kristinsson SY, Landgren O, Dickman PW, Derolf AR, Bjorkholm M. Patterns of survival in multiple myeloma: a population-based study of patients diagnosed in Sweden from 1973 to 2003. J Clin Oncol. 2007 May 20;25(15):1993-9. doi: 10.1200/JCO.2006.09.0100. Epub 2007 Apr 9.
PMID: 17420512BACKGROUNDKumar SK, Rajkumar SV, Dispenzieri A, Lacy MQ, Hayman SR, Buadi FK, Zeldenrust SR, Dingli D, Russell SJ, Lust JA, Greipp PR, Kyle RA, Gertz MA. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008 Mar 1;111(5):2516-20. doi: 10.1182/blood-2007-10-116129. Epub 2007 Nov 1.
PMID: 17975015BACKGROUNDLandgren O, Kyle RA, Pfeiffer RM, Katzmann JA, Caporaso NE, Hayes RB, Dispenzieri A, Kumar S, Clark RJ, Baris D, Hoover R, Rajkumar SV. Monoclonal gammopathy of undetermined significance (MGUS) consistently precedes multiple myeloma: a prospective study. Blood. 2009 May 28;113(22):5412-7. doi: 10.1182/blood-2008-12-194241. Epub 2009 Jan 29.
PMID: 19179464BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Roschewski, M.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 23, 2010
Study Start
April 22, 2010
Primary Completion
May 16, 2014
Study Completion
February 25, 2021
Last Updated
March 8, 2021
Record last verified: 2021-03