A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the treatment of Bone Metastases in subjects with Advanced Cancer (Excluding Breast and Prostate cancer) or Multiple Myeloma.

Double-blind study of denosumab compared with zoledronic acid in the treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma

Status

Active, not recruiting

Protocol ID

20050244

Purpose

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)

This is a Phase 3 clinical study.

Trial Criteria

Minimum Age: 18 years

Genders eligible for study: Both

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 PS 0, 1, or 2
• Adequate organ function


Exclusion Criteria:

• Diagnosis of breast or prostate cancer
• Current or prior IV bisphosphonate administration
• Current or prior oral bisphosphonates for bone mets, life expectancy of less than 6 months
• Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

Keywords

Bone metastases,lytic bone lesions,advanced cancer,multiple myeloma,lymphoma,solid tumors,skeletal related events,skeletal fractures,spinal cord compressions, radiation to bone,surgery to bone, bisphosphonates,denosumab