Phase 2
Completed N=96
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Source: ClinicalTrials.gov NCT00259740 ↗Enrolled (actual)
96
Serious AEs
21.1%
Results posted
Jan 2011
Primary outcomePrimary: Complete Response or Partial Response Based on M-Protein Assessments Only — 0; 0 Participants
Summary
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response or Partial Response Based on M-Protein Assessments Only |
0; 0 | — |
| SECONDARY Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only |
0; 0 | — |
| SECONDARY Complete Response Based on M-Protein Assessments Only |
0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00259740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.