Conditions: Cancer Hematologic Malignancies Multiple Myeloma Oncology Bone Metastases Multiple Myeloma Bone Lesions
Keywords: zoledronic acid hematologic malignancies SRE skeletal-related event blood cancer lytic bone lesions bone metastases myeloma fractures spinal cord compression radiation to bone surgery to bone bisphosphonates Neoplasms, Plasma Cell Paraproteinemias Neoplasms Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Blood Protein Disorders Hematologic Diseases multiple myeloma denosumab Neoplastic Processes Bone Diseases Diphosphonates Bone Density Conservation Agents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1718
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

Detailed description:

Arms:
arm 1: Zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaniously (SC) once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years) arm 2: Denosumab 120 mg subcutaniously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years)

Interventions: intervention 1: Denosumab intervention 2: Zoledronic acid intervention 3: Placebo to Denosumab intervention 4: Placebo to zoledronic acid intervention 5: Denosumab (for the open-label treatment phase)
Intervention descriptions: intervention 1: Administered by subcutaneous injection once every 4 weeks. intervention 2: Administered by intravenous infusion over 15 minutes once every 4 weeks intervention 3: Administered by subcutaneous injection once every 4 weeks. intervention 4: Administered by intravenous infusion over 15 minutes once every 4 weeks intervention 5: Administered by subcutaneous injection once every 4 weeks.

Protocol document: