Status:
COMPLETED
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Lead Sponsor:
Amgen
Conditions:
Relapsed or Plateau-Phase Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
Detailed Description
Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00259740
Start Date
November 1 2005
End Date
December 1 2011
Last Update
March 15 2017
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