The goal of this study is to find markers that may help to predict why some patients who have monoclonal gammopathy of unknown significance (MGUS) or smoldering multiple myeloma (SMM) that have no signs or symptoms of disease (asymptomatic) develop multiple myeloma, while others do not. Studying markers such as age, level of proteins in blood, percent of abnormal blood cells in the bone marrow, genes in the abnormal blood cells, and bone abnormalities may help researchers to validate clinical and genomic predictors for future use in clinical practice.
PRIMARY OBJECTIVE: I. To determine the rate of progression to multiple myeloma after 3 years of follow up. SECONDARY OBJECTIVES: I. To describe baseline patient characteristics and clinical variables. II. To identify molecular and genetic correlates that may predict for progression to multiple myeloma (MM). OUTLINE: Patients undergo collection of blood samples every 6 months for 3 years. Patients may also undergo a biopsy, x-rays, positron emission tomography (PET)/computed tomography (CT) scans, and/or magnetic resonance imaging (MRI) scans to check the status of disease at the discretion of the treating physician. After completion of 3 years on study, patients are followed up every 6-12 months thereafter.
Study Type
OBSERVATIONAL
Enrollment
200
Undergo collection of blood samples
Correlative studies
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGRate of progression to multiple myeloma (MM)
Kaplan-Meier method will be used to estimate time to MM progression. Log-rank test will be used to evaluate the difference in rate of progression between/among patient groups.
Time frame: 3 years
Progression free survival
Will be estimated using the Kaplan-Meier method. Log-rank test will be used to evaluate the difference in rate of progression free survival between/among patient groups.
Time frame: 3 years
Overall survival
Will be estimated using the Kaplan-Meier method. Log-rank test will be used to evaluate the difference in rate of overall survival between/among patient groups.
Time frame: 3 years
Baseline patient characteristics and clinical variables
Summary statistics including mean, standard deviation, median, and range will be provided for continuous variables. Frequency counts and percentages will be used to summarize categorical variables.
Time frame: Baseline
Molecular and genetic profile analysis
Will study the correlation of molecular and genetic profiles with time to MM progression.
Time frame: 3 years
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