Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00099047
First received: December 8, 2004
Last updated: April 11, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Monoclonal Gammopathy of Undetermined Significance Multiple Myeloma Smoldering Multiple Myeloma |
Drug: celecoxib Drug: placebo Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Changes in M-protein levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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:
- Changes in serum IL-6 levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in serum IL-6 receptor levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in serum beta-2 microglobulin levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in CD4+/CD8+ ratio [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in IL-1 beta levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in COX-2 staining [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
- Changes in peripheral blood labeling index [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 36 |
| Study Start Date: | November 2004 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (celecoxib)
Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Drug: celecoxib
Given PO
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
|
Drug: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00099047 History of Changes |
| Other Study ID Numbers: | NCI-2009-00866, CCF-IRB-7029, CDR0000393514, UARK-18697, MAYO-206904, N01CN25140 |
| Study First Received: | December 8, 2004 |
| Last Updated: | April 11, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Additional relevant MeSH terms:
|
Monoclonal Gammopathy of Undetermined Significance Paraproteinemias Multiple Myeloma Neoplasms, Plasma Cell Hypergammaglobulinemia Blood Protein Disorders Hematologic Diseases Immunoproliferative Disorders Immune System Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013