{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"11"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"description":"The frequency of subjects experiencing a specific adverse event will be tabulated overall and by each treatment course. In the by-subject analysis, a subject having the same event more than once will be counted only once. Adverse events will be summarized by worst NCI CTCAE grade. Laboratory data will be graded according to NCI CTCAE severity grade","groups":[{"description":"All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28, pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28-day cycle. Patients randomized to auto-SCT will proceed within 28 days after completion of the 4th cycle of ClaPD to receive melphalan 140mg/m2 or 200mg/m2 (as per institutional guidelines) followed by hematopoietic cell infusion.\n\nPomalidomide\n\nstem cell\n\nClarithromycin","id":"OG000","title":"Clarithromycin + Pomalidomide + Dexamethasone + Stem Cell"},{"description":"All patients will receive 4 cycles of clarithromycin 500mg twice daily on days 1-28 pomalidomide 4 mg daily on days 1 through 21 and dexamethasone orally at a dose of 40 mg daily on days 1, 8, 15, and 22 of each 28 day cycle. Patients assigned to ClaPD alone will receive 5 additional cycles of ClaPD.\n\nPomalidomide\n\nDexamethasone\n\nClarithromycin","id":"OG001","title":"Clarithromycin + Pomalidomide + Dexamethasone Alone"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"3 years","title":"Number of Participants With Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}