At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 96 enrolled
Drug / intervention
DENOSUMABdrug
Likely dose
Denosumab 120 mg subcutaneously on days 1, 8, 15, and 29, then every 28 days (60 mg × 2 injections per dose)AI-extracted
Key inclusion· 4
- ✓Age 18 years or older
- ✓Clinical diagnosis of relapsed or plateau-phase multiple myeloma
- ✓Measurable disease (>0.5 g/dL)
- ✓ECOG performance status 0 or 1
Key exclusion· 4
- ✕Newly diagnosed myeloma
- ✕Non-secretory myeloma
- ✕Plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome
- ✕Prior allogeneic stem cell transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating DENOSUMAB for Relapsed or Plateau-Phase Multiple Myeloma. Completed, enrolled 96 participants.
Detailed Summary
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedDec 2005
Primary CompletionAug 2007
Study CompletionDec 2011
TodayJul 2026
First PostedDec 1, 2005
Enrollment StartNov 1, 2005
Primary CompletionAug 1, 2007
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.6 years ago
Interventions
DENOSUMABdrug
120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.