Phase 2
N=96
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Relapsed or Plateau-Phase Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00259740 ↗Enrolled (actual)
96
Serious AEs
21.1%
Results posted
Jan 2011
Primary outcome: Primary: Complete Response or Partial Response Based on M-Protein Assessments Only — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DENOSUMAB (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Aug 2007
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 | — |
Summary
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
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.