TriangleNCT00099047 · STUDY IN CONTEXT
Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT00099047
- trial label
- Celecoxib in Preventing Multiple Myeloma in Patients With Monoclonal Gammopathy or Smoldering Myeloma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 1
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT00099047
- outcome key
- om-0000
- source section id
- NCT00099047-om-0000
- source outcome index
- 0
- endpoint
- Changes in M-protein Levels
- endpoint definition
- 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.
- time origin
- Baseline and 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT00099047
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Celecoxib)
- regimen
- Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00099047-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT00099047
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Placebo)
- regimen
- Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00099047-om-0000#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT00099047
- harm key
- EG000
- source section id
- NCT00099047-ae
- event group key
- EG000
- event group label
- Arm I (Celecoxib)
- serious affected
- 0
- serious at risk
- 11
- other affected
- 6
- other at risk
- 11
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-monoclonal-gammopathy-of-undetermined-significance
- nct id
- NCT00099047
- harm key
- EG001
- source section id
- NCT00099047-ae
- event group key
- EG001
- event group label
- Arm II (Placebo)
- serious affected
- 0
- serious at risk
- 12
- other affected
- 8
- other at risk
- 12
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice