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

Criteria:

• M-protein >= 30 g/L
• No clinical evidence of chronic infectious or inflammatory disease
• No present evidence of active malignancy (nonmelanoma skin cancer or cervical intraepithelial neoplasia allowed)
• No hypersensitivity (e.g., asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
• No hypersensitivity to sulfonamides
• No uncontrolled diabetes
• No history of diabetic retinopathy
• No condition that would preclude study participation
• No condition that would preclude the use of NSAIDs
• New or preexisting diagnosis of 1 of the following for at least 2 months:
• Monoclonal gammopathy of undetermined significance as defined by the following criteria:
• M-protein = = 10%
• No related organ or tissue impairment (i.e., end organ damage) or symptoms
• Asymptomatic patients with = = 1.0 g/dL for at least 2 consecutive lab readings taken at least 4 weeks apart
• No anemia
• No hepatic insufficiency
• AST or ALT 5 mg of prednisone or equivalent per day)
• More than 28 days since prior chronic or frequent use of non-steroidal anti-inflammatory drugs (NSAIDs) (> 100 mg of aspirin per day)
• More than 28 days since prior bisphosphonate therapy
• More than 28 days since prior investigational agents
• Concurrent low-dose aspirin ( =< 100 mg/day) allowed
• No evidence of other B-cell proliferative disorders (e.g., multiple myeloma, Waldenstrom's macroglobulinemia, primary amyloidosis, or lymphoproliferative disease)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• AND/OR
• ECOG 0-1 or Zubrod 0-1