{"denoms":[{"counts":[{"groupId":"BG000","value":"7"}],"units":"Participants"}],"groups":[{"description":"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.\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":"BG000","title":"LDE225 Plus Bortezomib"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"52","upperLimit":"84","value":"79"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Gender","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}],"title":"Caucasian"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"title":"Black or African AMerican"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}],"title":"Unknown"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}