Multiple Myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Amgen Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults with newly diagnosed multiple myeloma; - Radiographic evidence of at least 1 bone lesion; - Plan to receive 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; - Previous treatment 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 40 mg/day for 4 days]). Anti-myeloma therapy (excluding bisphosphonates) may be started before randomization if the subject has signed informed consent and screening blood samples have been collected for central analysis. - Planned radiation therapy or surgery to bone (does not include procedures; performed before randomization) - Prior administration of denosumab; - Prior or current IV bisphosphonate administration; - Use of oral bisphosphonates within the past 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 progression-free survival and 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 800 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: - Progression-free survival (PFS); - 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 800 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, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info ? Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed