{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Time to progression (TTP) is measured from Day 1 of study drug administration to disease progression using International Myeloma Working Group (IMWG) Uniform Response Criteria.","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"}],"populationDescription":"This outcome measure was to be assessed during the expansion phase of the study. The study closed early and did not proceed to this phase of the study. There is no data to report for this outcome measure.","reportingStatus":"POSTED","timeFrame":"every 3 weeks up to 48 weeks, then every 3 months thereafter up to 3 years from initiation of study treatment.","title":"Time to Disease Progression","type":"PRIMARY"}