Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma

Phase 2

Completed

Conditions: Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma

Interventions: Drug: placebo
Drug: celecoxib
Other: laboratory biomarker analysis

Brief Summary: This randomized phase II trial studies how well celecoxib works in preventing multiple myeloma in patients with monoclonal gammopathy or smoldering myeloma. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing multiple myeloma.

Detailed Description: PRIMARY OJBECTIVES:

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.

SECONDARY OBJECTIVES:

I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients.

OUTLINE:

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm II (placebo)	laboratory biomarker analysis	Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm I (celecoxib)	laboratory biomarker analysis	Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm II (placebo)	placebo	Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm I (celecoxib)	celecoxib	Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

Primary Outcome Measures

Name	Time	Method
Changes in M-protein Levels	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.

Secondary Outcome Measures