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Study Complete
Sponsor ID
20050134

Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab

Sponsor ID
20050134
Clinicaltrials.gov ID
NCT00259740
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
96
Additional Study Details

Protocol Summary

Primary Outcome Measures

Complete Response or Partial Response Based on M-Protein Assessments Only

Timeframe: Up to 18 months

Secondary Outcome Measures

Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only

Timeframe: Up to 18 months

Complete Response Based on M-Protein Assessments Only

Timeframe: Up to 18 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Multiple Myeloma
    • Sex
    All
    Trial Dates
    Nov 2005 - Aug 2007
    Inclusion and Exclusion 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.