{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"Maximum Phase II planned dose of cyclophosphamide when given in combination with bortezomib, pegylated liposomal doxorubicin and Dexamethasone (CVDD) in participants with newly diagnosed active multiple myeloma. Dose levels 1, 2, 3, 4 as outlined in Treatment Arm A.\n\nIf no dose limiting toxicity (DLT) was reported in the first 3 participants at a dose level, that dose level was to be considered safe and 3 participants would be enrolled at the next dose level. If 1/3 participants in a cohort at a dose level had dose limiting toxicity (DLT), the dose level would be expanded to obtain 6 evaluable participants. MPD reflects the highest dose of drug that did not cause a DLT in 33% of participants.","groups":[{"description":"Dose of Cyclophosphamide depended on how many patients we had treated. Three participants were treated at each level:\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","id":"OG000","title":"A. Phase I Dose Escalation"}],"paramType":"NUMBER","populationDescription":"All participants in Arm A. Three participants at each dose level.","reportingStatus":"POSTED","timeFrame":"9 months","title":"Phase I - Maximum Planned Dose (MPD) Level","type":"PRIMARY","unitOfMeasure":"Dosing Level"}