Multiple Myeloma Clinical Trial
Official title:
Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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