Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma

• Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2

• Adequate organ function

Exclusion Criteria:

• Diagnosis of breast or prostate cancer

• Current or prior intravenous bisphosphonate administration

• Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months

• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw