Monoclonal Gammopathy of Undetermined SignificancePhase 2NCT00099047
Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
A Phase 2 study testing celecoxib and laboratory biomarker analysis in people with Monoclonal Gammopathy of Undetermined Significance and Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
- What is being tested?
- celecoxib and laboratory biomarker analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma
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.
Read the detailed description
PRIMARY OJBECTIVES:
- 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:
- 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.
- Conditions
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
- Being tested
- celecoxib, placebo, laboratory biomarker analysis
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called Celebrex
Given PO
placeboDrug
Given PO
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (celecoxib) | Experimental | Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. Receives: 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. Receives: Drug: placebo; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2004 (estimated)
- Study startNov 2004
- Primary completionJun 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matt Kalaycio, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099047
- Sponsor's protocol ID
- NCI-2009-00866
- Other IDs
- NCI-2009-00866, CDR0000393514, UARK-18697, MAYO-206904, CCF-IRB-7029, N01-CN-25140, N01CN25140
- Status last verified
- Dec 2016
- First submitted
- 8 Dec 2004
- Last updated
- 30 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic and Clinical Role of COX-2 Inhibitor (Celecoxib)in the Management of MGUS and Smoldering Myeloma
- ClinicalTrials.gov ID
- NCT00099047
- Acronym / sponsor ID
- NCI-2009-00866
- Conditions
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 9 Dec 2004 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (celecoxib) | Experimental | Drug: celecoxib, Other: laboratory biomarker analysisPatients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. |
| Arm II (placebo) | Placebo comparator | Drug: placebo, Other: laboratory biomarker analysisPatients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxibAlso: CelebrexGiven PO | Drug | Arm I (celecoxib) |
| placeboGiven PO | Drug | Arm II (placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (celecoxib), Arm II (placebo) |
Primary outcome
Changes in M-protein Levels
Time frame: Baseline and 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Kalaycio, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib and laboratory biomarker analysis in people with Monoclonal Gammopathy of Undetermined Significance and Multiple Myeloma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in M-protein Levels (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.