Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
About this trial
This is an interventional prevention trial for Monoclonal Gammopathy of Undetermined Significance
Eligibility Criteria
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 =< 30 g/L Bone marrow clonal plasma cells < 10% and low level of plasma cell infiltration in a trephine biopsy (if done) Smoldering myeloma as defined by at least 1 of the following criteria: Bone marrow clonal plasma cells >= 10% No related organ or tissue impairment (i.e., end organ damage) or symptoms Asymptomatic patients with =< 3 lytic lesions (without other organ damage) attributable to plasma cell dyscrasia allowed No condition associated with a secondary monoclonal gammopathy IgG, IgA, or light chain M-component >= 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 < 1.5 times upper limit of normal (ULN) Bilirubin =< 1.5 times ULN Creatinine =< 1.8 mg/dL No hypercalcemia No renal insufficiency No uncontrolled congestive heart failure No history of cerebrovascular or cardiovascular accident No history of gastrointestinal hemorrhage No active or suspected peptic ulcer disease Previously treated H. pylori infection allowed More than 12 months since limited chemotherapy More than 28 days since prior chronic or frequent use of glucocorticoids (> 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
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Arm I (celecoxib)
Arm II (placebo)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.