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

Amgen1,779 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

1,779

Conditions

Bone Metastases

Interventions

DenosumabBIOLOGICAL

120 milligrams by subcutaneous injection every 4 weeks

Zoledronic AcidDRUG

4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Time to the First On-Study Skeletal-Related Event (Non-Inferiority)

Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.

Time frame: up to 33 months

Secondary Outcomes

Time to First On-Study Skeletal-Related Event (Superiority)

Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.

Time frame: up to 33 months

Time to the First-and-Subsequent On-Study Skeletal-Related Event

Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.

Time frame: up to 33 months

Data from ClinicalTrials.gov

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