{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}],"title":"Progressive Disease"},{"measurements":[{"groupId":"OG000","value":"3"}],"title":"Stable Disease"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"}],"units":"Participants"}],"description":"Number of patients with confirmed Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Progressive Disease (PD) or Stable Disease (SD) according to International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=5% or less plasma cells in bone marrow, disappearance of soft tissue plasmacytoma, negative immunofixation on serum and urine. VGPR=Serum and urine M-protein detectable by immunofixation but not by electrophoresis, disappearance of any soft tissue plasmacytomas that were present at baseline. PR= at least 50% reduction from baseline in serum M-protein and at least 90% reduction from baseline in 24hr urinary M-protein. PD=Increase of 25% or more from nadir in serum or urine proteins. SD= not meeting criteria for CR, VGPR, PR or PD.","groups":[{"description":"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.\n\nBortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.\n\nExpansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.\n\nMaintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity.","id":"OG000","title":"LDE225 Plus Bortezomib"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Of 7 enrolled patients, 1 was deemed ineligible and was excluded from efficacy analyses. At a median follow-up of 6 weeks, 3 patients in Cohort 1 had progressive disease and 3 had stable disease. Study was terminated after reviewing data from this first lead-in cohort.","reportingStatus":"POSTED","timeFrame":"Every 3 weeks up to 48 weeks","title":"Overall Response","type":"SECONDARY","unitOfMeasure":"Participants"}