Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma

Inclusion 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