Clinical trial NCT00099047: Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Official title: Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Monoclonal Gammopathy of Undetermined Significance
Multiple Myeloma
Smoldering Multiple Myeloma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-12-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be effective in preventing multiple myeloma.

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.

SECONDARY OBJECTIVES:

I. Determine the effects of this drug on secondary biomarkers as surrogate endpoints in these patients.

OUTLINE:

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and type of monoclonal gammopathy (monoclonal gammopathy of undetermined significance vs smoldering myeloma). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive celecoxib orally (PO) twice daily (BID) for 6 months in the absence of unacceptable toxicity or progression to malignancy.

ARM II: Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

After completion of study treatment, patients are followed at 1, 6, and 12 months.

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

Primary outcomes:
measure: Changes in M-protein Levels
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Matt Kalaycio, MD
role: PRINCIPAL_INVESTIGATOR
References: