Multiple Myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults with documented evidence of multiple myeloma (per local assessment); - Radiographic evidence of at least 1 bone lesion; - Plan to receive or is receiving primary frontline anti-myeloma therapies; - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; - Adequate organ function; - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 560 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 960
Exclusion criteria
Exclusion criteria: - Nonsecretory multiple myeloma (unless baseline serum free light chain level is elevated); - Plasma cell leukemia; - Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome; - More than 30 days of previous treatment (before screening) with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 60 mg/day for 4 days]). - Planned radiation therapy or surgery to bone (does not include procedures; performed before randomization) - Prior administration of denosumab; - More than 1 previous dose of IV bisphosphonate administration; - Use of oral bisphosphonates with a cumulative exposure of more than 1 year; - Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event (SRE) in subjects with multiple myeloma;Secondary Objective: - To determine if denosumab is superior to zoledronic acid with respect to the first on-study SRE; - To determine if denosumab is superior to zoledronic acid with respect to the first and subsequent on-study SRE (multiple event analysis); - To assess the treatment effects of denosumab and zoledronic acid on overall survival - To assess the safety and tolerability of denosumab compared with zoledronic acid.;Primary end point(s): Time to the first on-study SRE (non-inferiority) SRE is an aggregate endpoint that includes pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. ;Timepoint(s) of evaluation of this end point: Primary analysis cut-off date is event-driven (i.e. when approximately 676 subjects have experienced at least one on-study SRE) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to the first on-study SRE (superiority); - Time to the first-and-subsequent on-study SRE (superiority, using multiple event analysis); Additional Secondary Endpoints: - Overall survival (OS); Safety Endpoints: - Subject incidence of treatment emergent adverse events; - Changes in laboratory values; - Incidence of anti-denosumab antibody (binding and neutralizing) formation.;Timepoint(s) of evaluation of this end point: Primary analysis cut-off date is event-driven (i.e. when approximately 676 subjects have experienced at least one on-study SRE) | — |
Countries
Australia, Austria, Bulgaria, Canada, Czech Republic, European Union, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Republic of, Lithuania, Malaysia, New Zealand, Portugal, Russian Federation, Singapore, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info – Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed