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

Primary Purpose

Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
placebo
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Monoclonal Gammopathy of Undetermined Significance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (celecoxib)

Arm II (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2004
Last Updated
December 28, 2016
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00099047
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (celecoxib)
Arm Type
Experimental
Arm Description
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Arm Title
Arm II (placebo)
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Changes in M-protein Levels
Description
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.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Kalaycio, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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