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NCT00099047 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2016-12-30

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Changes in M-protein Levels

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
    intervention Names
    1. Drug: celecoxib
    2. Other: laboratory biomarker analysis
    label
    Arm I (celecoxib)
    type
    EXPERIMENTAL
  2. description
    Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
    intervention Names
    1. Drug: placebo
    2. Other: laboratory biomarker analysis
    label
    Arm II (placebo)
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I (celecoxib)
    description
    Given PO
    name
    celecoxib
    other Names
    1. Celebrex
    type
    DRUG
  2. arm Group Labels
    1. Arm II (placebo)
    description
    Given PO
    name
    placebo
    type
    DRUG
  3. arm Group Labels
    1. Arm I (celecoxib)
    2. Arm II (placebo)
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
PREVENTION
Enrollment
count
23
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Changes in M-protein Levels
    time Frame
    Baseline and 6 months
Full 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-57daadad763a2161d73a
      requested nct id
      NCT00099047
      primary nct id
      NCT00099047
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      c5266c680d526c217b7ce3ebd157e4c90548359af31be32ba14fdf7e6390007f
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-57daadad763a2161d73a
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00099047
      occurrences
      1. context exact
        NCT00099047
        end
        11
        exact text
        NCT00099047
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/900/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      0e4c7b307d08357488798f40bc97e5b1c9cafef50319ad6701ed023462ac55dd

    Preserved source evidence · Not medical advice