Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Smoldering Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (celecoxib)

Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.

Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm II (placebo)

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Given PO

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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celecoxib

Given PO

Intervention Type DRUG

placebo

Given PO

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Celebrex

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matt Kalaycio, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States