{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"1"},{"groupId":"OG014","value":"1"},{"groupId":"OG015","value":"0"},{"groupId":"OG022","value":"0"},{"groupId":"OG023","value":"1"},{"groupId":"OG024","value":"0"},{"groupId":"OG025","value":"1"},{"groupId":"OG026","value":"0"},{"groupId":"OG027","value":"1"},{"groupId":"OG028","value":"1"},{"groupId":"OG029","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"6"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"3"},{"groupId":"OG008","value":"3"},{"groupId":"OG009","value":"3"},{"groupId":"OG010","value":"3"},{"groupId":"OG011","value":"3"},{"groupId":"OG012","value":"3"},{"groupId":"OG013","value":"6"},{"groupId":"OG014","value":"6"},{"groupId":"OG015","value":"3"},{"groupId":"OG016","value":"0"},{"groupId":"OG017","value":"0"},{"groupId":"OG018","value":"0"},{"groupId":"OG019","value":"0"},{"groupId":"OG020","value":"0"},{"groupId":"OG021","value":"0"},{"groupId":"OG022","value":"3"},{"groupId":"OG023","value":"6"},{"groupId":"OG024","value":"3"},{"groupId":"OG025","value":"6"},{"groupId":"OG026","value":"3"},{"groupId":"OG027","value":"6"},{"groupId":"OG028","value":"3"},{"groupId":"OG029","value":"6"},{"groupId":"OG030","value":"0"},{"groupId":"OG031","value":"0"},{"groupId":"OG032","value":"0"},{"groupId":"OG033","value":"0"},{"groupId":"OG034","value":"0"},{"groupId":"OG035","value":"0"},{"groupId":"OG036","value":"0"}],"units":"Participants"}],"description":"The dose-limiting toxicity (DLT) population includes subjects who missed no more than 4 doses of CC-220, 2 doses of DEX, 1 dose of IV DARA (Cohort E), 1 dose of BTZ (Cohort F), or 1 dose of CFZ (Cohort G1 or G2) during Cycle 1 for reasons other than DLT. This population will be used for analyzing the primary endpoint regarding the determination of the MTD.\n\nHematologic DLTs:\n\nGrade 4 neutropenia (ANC \\<500/μL for \\>5 days) Grade 3 neutropenia (ANC \\<1,000/μL) with fever ≥38.5°C Grade 4 thrombocytopenia (platelet count \\<25,000/μL) or Grade 3 thrombocytopenia with bleeding or need for platelet transfusion Any other grade 4 hematologic toxicity, except anemia, not resolving to pretreatment baseline within 72 hours.\n\nNon-hematologic DLT:\n\nAny non-hematological toxicity ≥ Grade 3, except alopecia and nausea controlled by medical management.","groups":[{"description":"CC220 0.30mg","id":"OG000","title":"Cohort A: Treatment 1"},{"description":"CC220 0.45mg","id":"OG001","title":"Cohort A: Treatment 2"},{"description":"CC220 0.60mg","id":"OG002","title":"Cohort A: Treatment 3"},{"description":"CC220 0.75mg","id":"OG003","title":"Cohort A: Treatment 4"},{"description":"CC220 0.90mg","id":"OG004","title":"Cohort A: Treatment 5"},{"description":"CC220 1.0mg","id":"OG005","title":"Cohort A: Treatment 6"},{"description":"CC220 0.30mg + DEX","id":"OG006","title":"Cohort B: Treatment 1"},{"description":"CC220 0.45mg + DEX","id":"OG007","title":"Cohort B: Treatment 2"},{"description":"CC220 0.60mg + DEX","id":"OG008","title":"Cohort B: Treatment 3"},{"description":"CC220 0.75mg + DEX","id":"OG009","title":"Cohort B: Treatment 4"},{"description":"CC220 0.90mg + DEX","id":"OG010","title":"Cohort B: Treatment 5"},{"description":"CC220 1.0mg + DEX","id":"OG011","title":"Cohort B: Treatment 6"},{"description":"CC220 1.1mg + DEX","id":"OG012","title":"Cohort B: Treatment 7"},{"description":"CC220 1.2mg + DEX","id":"OG013","title":"Cohort B: Treatment 8"},{"description":"CC220 1.3.mg + DEX","id":"OG014","title":"Cohort B: Treatment 9"},{"description":"CC220 1.6mg + DEX","id":"OG015","title":"Cohort B: Treatment 10"},{"description":"CC220 + DEX","id":"OG016","title":"Cohort D: Treatment 1"},{"description":"CC220 1.0mg + DARA + DEX","id":"OG017","title":"Cohort E: Treatment 1"},{"description":"CC220 1.1mg + DARA + DEX","id":"OG018","title":"Cohort E: Treatment 2"},{"description":"CC220 1.2mg + DARA + DEX","id":"OG019","title":"Cohort E: Treatment 3"},{"description":"CC220 1.3mg + DARA + DEX","id":"OG020","title":"Cohort E: Treatment 4"},{"description":"CC220 1.6mg + DARA + DEX","id":"OG021","title":"Cohort E: Treatment 5"},{"description":"CC220 1.0mg + BORT + DEX","id":"OG022","title":"Cohort F: Treatment 1"},{"description":"CC220 1.1mg + BORT + DEX","id":"OG023","title":"Cohort F: Treatment 2"},{"description":"CC220 1.3mg + BORT + DEX","id":"OG024","title":"Cohort F: Treatment 3"},{"description":"CC220 1.6mg + BORT + DEX","id":"OG025","title":"Cohort F: Treatment 4"},{"description":"CC220 1.1mg + CFZ + DEX","id":"OG026","title":"Cohort G: Treatment 1"},{"description":"CC220 1.3mg + CFZ + DEX","id":"OG027","title":"Cohort G: Treatment 2"},{"description":"CC220 1.6mg + CFZ + DEX","id":"OG028","title":"Cohort G: Treatment 3"},{"description":"CC220 + DEX","id":"OG029","title":"Cohort H1"},{"description":"CC220 + DEX","id":"OG030","title":"Cohort H2"},{"description":"CC220 + DEX","id":"OG031","title":"Cohort I"},{"description":"CC220Vd 1.0mg + NE-ASCT","id":"OG032","title":"Cohort J1: Treatment 1"},{"description":"CC220Vd 1.6mg + NE-ASCT","id":"OG033","title":"Cohort J1: Treatment 2"},{"description":"CC220 1.0mg + DARA + DEX","id":"OG034","title":"Cohort K: Treatment 1"},{"description":"CC220 1.3mg + DARA + DEX","id":"OG035","title":"Cohort K: Treatment 2"},{"description":"CC220 1.6mg + DARA + DEX","id":"OG036","title":"Cohort K: Treatment 3"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT evaluable population in Part 1. Part 1 of the study consisted of Cohorts A, B, F, G and H1 as per protocol.","reportingStatus":"POSTED","timeFrame":"From first dose to 28 days post last dose (up to 28 days)","title":"Number of Participants With Dose Limiting Toxicities in Part 1.","type":"PRIMARY","unitOfMeasure":"Participants"}