Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Condition: Monoclonal Gammopathy of Undetermined Significance; Multiple Myeloma; Smoldering Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance
Intervention: celecoxib; placebo; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Correlative studies
Intervention MeSH terms: Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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