Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma
I. Determine the efficacy of celecoxib vs placebo in reducing serum levels of M-component in
patients with monoclonal gammopathy of undetermined significance or smoldering myeloma.
I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in
This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are
stratified according to participating center and type of monoclonal gammopathy (monoclonal
gammopathy of undetermined significance vs smoldering myeloma). Patients are randomized to 1
of 2 treatment arms.
ARM I: Patients receive celecoxib orally (PO) twice daily (BID) for 6 months in the absence
of unacceptable toxicity or progression to malignancy.
ARM II: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity
or progression to malignancy.
After completion of study treatment, patients are followed at 1, 6, and 12 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Changes in M-protein levels
For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.
Baseline and 6 months
The Cleveland Clinic
United States: Food and Drug Administration
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