{"eventGroups":[{"description":"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)\n\n•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:\n\nCohort 1: add CFZ 20 mg/m\\^2 intravenous (IV) on days +1, +2\n\nCohort 2 : add CFZ 20 mg/m\\^2 IV on days: +1, +2, +8, +9\n\nCohort 3: add CFZ 20 mg/m\\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\\^2 IV given on days 42-43 then CFZ 56 mg/m\\^2 IV given on days 49-50, 56-57, then on days 70.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Cohort 1- CFZ 20 mg/m^2 (Day 1,2)"},{"description":"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)\n\n•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:\n\nCohort 1: add CFZ 20 mg/m\\^2 intravenous (IV) on days +1, +2\n\nCohort 2 : add CFZ 20 mg/m\\^2 IV on days: +1, +2, +8, +9\n\nCohort 3: add CFZ 20 mg/m\\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\\^2 IV given on days 42-43 then CFZ 56 mg/m\\^2 IV given on days 49-50, 56-57, then on days 70.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)"},{"description":"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)\n\n•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:\n\nCohort 1: add CFZ 20 mg/m\\^2 intravenous (IV) on days +1, +2\n\nCohort 2 : add CFZ 20 mg/m\\^2 IV on days: +1, +2, +8, +9\n\nCohort 3: add CFZ 20 mg/m\\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\\^2 IV given on days 42-43 then CFZ 56 mg/m\\^2 IV given on days 49-50, 56-57, then on days 70.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"White blood cell decreased"}]}