Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
Bone Metastases
About this trial
This is an interventional supportive care trial for Bone Metastases focused on measuring 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
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
zoledronic acid
denosumab
denosumab placebo with active zoledronic acid
active denosumab with zoledronic acid placebo