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

NCT00099047 | Completed Phase 2 Results DMC

• 7 other identifiers: NCI-2009-00866CDR0000393514UARK-18697MAYO-206904CCF-IRB-7029N01-CN-25140N01CN25140
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm I (celecoxib)

EXPERIMENTAL

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

Drug: celecoxib; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

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

Drug: placebo; Other: laboratory biomarker analysis

Interventions

celecoxib DRUG

Given PO

Also known as: Celebrex

Arm I (celecoxib)

placebo DRUG

Given PO

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (celecoxib); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

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

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

No overall limitations or caveats for this trial.

Results Point of Contact

• Title: Matt Kalaycio, MD
• Organization: Cleveland Clinic

kalaycm@ccf.org

216-444-3705

Study Officials

• Matt Kalaycio, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: November 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 30, 2016
• Results First Posted: June 9, 2015

Record last verified: 2016-12

Locations

US (1)