Clinical trial · Interventional
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
NCT00259740CI-TRIAL-00026466completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Plateau-Phase Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DENOSUMAB | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Denosumab
- interventionNames
- Drug: DENOSUMAB
Primary outcomes (1)
- measure
- Complete Response or Partial Response Based on M-Protein Assessments Only
- timeFrame
- Up to 18 months
- description
- Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
Secondary outcomes (2)
- measure
- Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
- timeFrame
- Up to 18 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age ≥ 18 years * clinical diagnosis of relapsed or plateau-phase multiple myeloma * measurable disease (\>0.5 g/dL) as determined by special blood tests * ECOG 0 or 1 Exclusion Criteria: * newly diagnosed myeloma * non-secretory myeloma * plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome * prior allogeneic stem cell transplant * administration of oral or IV bisphosphonates within 2 weeks of enrollment to study Other criteria also apply.
References
Publications (1)
- BACKGROUNDVij R, Horvath N, Spencer A, Taylor K, Vadhan-Raj S, Vescio R, Smith J, Qian Y, Yeh H, Jun S. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009 Oct;84(10):650-6. doi: 10.1002/ajh.21509. PMID 19714603