Status:
COMPLETED
Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 certa...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00099047
Start Date
November 1 2004
End Date
November 1 2008
Last Update
December 30 2016
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195