CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
celecoxib +2 moredrug
Likely dose
Celecoxib oral dose not specified in trial recordAI-extracted
Key inclusion· 6
  • ✓M-protein ≥30 g/L
  • ✓New or preexisting diagnosis of MGUS or smoldering myeloma for at least 2 months
  • ✓MGUS: M-protein ≤30 g/L, bone marrow clonal plasma cells <10%
  • ✓Smoldering myeloma: bone marrow clonal plasma cells ≥10% OR M-protein ≥1.0 g/dL with stable disease for ≥2 consecutive lab readings ≥4 weeks apart
Key exclusion· 7
  • ✕Hypersensitivity to NSAIDs, aspirin, or sulfonamides
  • ✕Uncontrolled diabetes or history of diabetic retinopathy
  • ✕History of gastrointestinal hemorrhage, active peptic ulcer disease, or cardiovascular/cerebrovascular accident
  • ✕Uncontrolled congestive heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00099047
NCT00099047Phase 2Completed
CompareCT.gov

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

National Cancer Institute (NCI)·interventional·Posted Dec 9, 2004·Updated Dec 30, 2016

In Brief

A Phase 2 clinical trial evaluating celecoxib, placebo, and 1 other intervention for Monoclonal Gammopathy of Undetermined Significance and 2 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMonoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 9, 2004
Enrollment StartNov 1, 2004
Primary CompletionJun 1, 2008
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 21.6 years ago

Interventions

celecoxibdrug

Given PO

placebodrug

Given PO

laboratory biomarker analysisother

Correlative studies