Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma|
- Changes in M-protein Levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2004|
|Study Completion Date:||November 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: Arm I (celecoxib)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Other Name: CelebrexOther: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Given POOther: laboratory biomarker analysis
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 these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00099047
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Matt Kalaycio, MD||The Cleveland Clinic|