{"classes":[{"categories":[{"measurements":[{"comment":"Confidence interval could not be calculated due to a low number of events.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"100"},{"groupId":"OG001","lowerLimit":"14.7","upperLimit":"100","value":"41.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"Symptomatic myeloma PFS is defined as time from randomization to the first instance of criteria for multiple myeloma (MM). MM is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following:\n\n* Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium \\>0.25 mmol/L (\\>1 mg/dL) higher than the upper limit of normal or \\>2.75 mmol/L (\\>11 mg/dL); Renal insufficiency: creatinine clearance \\<40 mL per min or serum creatinine \\>177 μmol/L (\\>2 mg/dL); Anaemia: haemoglobin value of \\>20 g/L below the lower limit of normal, or a haemoglobin value \\<100 g/L; Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT\n* Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60%; Involved:uninvolved serum free light chain ratio ≥100 ; \\>1 focal lesions on MRI studies","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive 4 mg ixazomib by mouth on days 1, 8 and 15. Patients also receive 15 mg lenalidomide by mouth on days 1-21, 12 mg dexamethasone by mouth on days 1, 8, 15, and 22 and zoledronic acid (dose based on creatinine clearance on day 1) IV infusion on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.","id":"OG000","title":"Ixazomib + Lenalidomide + Dexamethasone + Zoledronic Acid"},{"description":"Patients receive zoledronic acid (dose based on creatinine clearance on day 1) IV on day 1. Patients receive treatment every 28 days for a maximum of 6 cycles.","id":"OG001","title":"Zoledronic Acid"}],"paramType":"NUMBER","populationDescription":"All eligible patients who began protocol treatment","reportingStatus":"POSTED","timeFrame":"18 months","title":"Symptomatic Myeloma Progression Free-survival (PFS) Rate","type":"PRIMARY","unitOfMeasure":"percentage of participants"}