{"denoms":[{"counts":[{"groupId":"BG000","value":"95"}],"units":"Participants"}],"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\nFor Phase 1, the design was a standard 3+3 study 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 (overall N=15). The Phase 2 portion of the study enrolled 80 subjects 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":"BG000","title":"KW-2478 and Bortezomib"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.3","value":"64.3"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"54"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"22"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"8"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"61"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}],"title":"Philippines"},{"categories":[{"measurements":[{"groupId":"BG000","value":"57"}]}],"title":"United Kingdom"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"0.27","value":"1.87"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Body Surface Area (BSA)","unitOfMeasure":"m^2"}],"populationDescription":"A total of up to 101 male and female subjects at least 18 years of age with a confirmed diagnosis of MM, who failed at least 1 and no more than 3 prior chemotherapy regimens and met other inclusion criteria and none of exclusion criteria, were to be enrolled in this study over a period of 22 months (up to 24 subject in P1 and 77 subjects in P2)."}