Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00099047|
Recruitment Status : Completed
First Posted : December 9, 2004
Results First Posted : June 9, 2015
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Smoldering Multiple Myeloma||Drug: celecoxib Drug: placebo Other: laboratory biomarker analysis||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma|
|Study Start Date :||November 2004|
|Primary Completion Date :||June 2008|
|Study Completion Date :||November 2008|
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
- Changes in M-protein Levels [ Time Frame: Baseline and 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099047
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Matt Kalaycio, MD||The Cleveland Clinic|