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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099047
• Other study ID #: NCI-2009-00866
• Secondary ID: NCI-2009-00866CD
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2004
• Last updated: December 28, 2016
• Start date: November 2004
• Est. completion date: November 2008

Study information

• Verified date: December 2016
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Smoldering Multiple Myeloma

Intervention

Drug:
• celecoxib
Given PO
• placebo
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in M-protein Levels	For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.	Baseline and 6 months	No