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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab

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.