{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Participants with Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}],"title":"Participants with Very Good Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"}]}],"title":"Participants with Complete Response"}],"denoms":[{"counts":[{"groupId":"OG000","value":"54"}],"units":"Participants"}],"description":"Best response to CVDD chemotherapy. Overall Response: Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR). PR: ≥ 50% reduction of serum M-protein and reduction in 24 hour urinary M-protein by ≥ 90% or to \\< 200 mg per 24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein with urine M-protein level \\< 100 mg per 24 hours; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.","groups":[{"description":"Arm A:\n\n* Dose Level 1: Cyclophosphamide 250 mg /m\\^2 IV Day 1; VELCADE, 1.0 mg/m\\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12\n* Dose Level 2: Cyclophosphamide 500 mg /m\\^2 IV Day 1; VELCADE, 1.0 mg/m\\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12\n* Dose Level 3: Cyclophosphamide 750 mg /m\\^2 IV Day 1; VELCADE, 1.0 mg/m\\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12\n* Dose Level 4: Cyclophosphamide 750 mg /m\\^2 IV Day 1; VELCADE, 1.3 mg/m\\^2 IV days 1,4,8, and 11; DOXIL 30 mg/m\\^2 Day 4; Dexamethasone 20 mg orally daily on days 1-2,4-5,8-9,11-12\n\nArm B:\n\nParticipants received Cyclophosphamide and VELCADE at Level 4 (the MPD) at the same schedule of the Phase I study. Pegylated doxorubicin and Dexamethasone were given at the same doses and schedule as the Phase I part of study.","id":"OG000","title":"All Participants"}],"paramType":"NUMBER","populationDescription":"All Participants with Partial Response, Very Good Partial Response, or Complete Response.","reportingStatus":"POSTED","timeFrame":"Up to 6 months","title":"Phase II: Overall Response Rate (ORR)","type":"PRIMARY","unitOfMeasure":"participants"}