{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"80"}]}],"title":"Subjects with Any TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"74"}]}],"title":"Related TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"22"}]}],"title":"Moderate (CTCAE 2) TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"42"}]}],"title":"Severe (CTCAE 3) TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"12"}]}],"title":"Life Threatening TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"36"}]}],"title":"Serious Treatment-Emergent AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"}]}],"title":"Subjects with Any DLT"}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"80"}],"units":"Participants"}],"description":"The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses.\n\nThe ORR, was defined as the best response over a specified number of cycles (calculated and summarized).\n\nDisease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized).","groups":[{"description":"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.\n\nThe Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m\\^2) and Bortezomib (1.0 or 1.3 mg/m\\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.\n\nThe Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\\^2/Bortezomib 1.3 mg/m\\^2).","id":"OG000","title":"Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2"},{"description":"Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.","id":"OG001","title":"Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2"},{"description":"Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.","id":"OG002","title":"Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2"},{"description":"Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.","id":"OG003","title":"Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2"},{"description":"Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.","id":"OG004","title":"Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2"},{"description":"Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m\\^2/Bortezomib 1.3 mg/m\\^2).","id":"OG005","title":"Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2"}],"paramType":"NUMBER","populationDescription":"All subjects who received at least 1 dose, including a partial dose, of KW-2478 were evaluated for safety.","reportingStatus":"POSTED","timeFrame":"21 day cycle, up to 52 weeks","title":"To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).","type":"PRIMARY","unitOfMeasure":"participants"}