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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Changes in M-protein levels

Outcome 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.

Outcome Time Frame:

Baseline and 6 months

Safety Issue:

No

Principal Investigator

Rachid Baz

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00866

NCT ID:

NCT00099047

Start Date:

November 2004

Completion Date:

Related Keywords:

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

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195