{"groups":[{"description":"JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles","id":"FG000","title":"Phase I - JNJ-26866138 0.7 mg/m2 Group"},{"description":"JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles","id":"FG001","title":"Phase I - JNJ-26866138 1.0 mg/m2 Group"},{"description":"Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles","id":"FG002","title":"Phase I and II - JNJ-26866138 1.3 mg/m2 Group"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"19"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"8"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"7"}],"type":"Unrecovered toxicity"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Pneumonitis or pulmonary fibrosis"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"4"}],"type":"Complete response observed over 2 cycles"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"}],"type":"Other"}],"milestones":[{"achievements":[{"comment":"Number of participants treated","groupId":"FG000","numSubjects":"6"},{"comment":"Number of participants treated","groupId":"FG001","numSubjects":"6"},{"comment":"Number of participants treated","groupId":"FG002","numSubjects":"87"}],"type":"STARTED"},{"achievements":[{"comment":"Completed all 9 cycles","groupId":"FG000","numSubjects":"3"},{"comment":"Completed all 9 cycles","groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"28"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"59"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"18 participants were enrolled and treated in Phase I. Total 89 participants were enrolled in Phase II (including 6 participants receiving 1.3 mg/m2 in the Phase I part). Of the 89 participants, 87 were received at least 1 dose of study medication. 2 participants were not treated.","recruitmentDetails":"Total 101 participants (Phase I: 18 and Phase II: 83) were enrolled at multiple sites in Japan."}