{"analyses":[{"ciLowerLimit":"-0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.18","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.25","paramType":"Risk Difference (RD)","paramValue":"-0.25","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"description":"Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.","groups":[{"description":"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.\n\nbortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11\n\ncyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)","id":"OG000","title":"Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF"},{"description":"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection\n\nbortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)","id":"OG001","title":"Arm B: VELCADE & G-CSF"},{"description":"High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.\n\ncyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)","id":"OG002","title":"Arm C: CYCLOPHOSPHAMIDE & G-CSF"},{"description":"G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)\n\nPlerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)","id":"OG003","title":"Arm D: PLERIXAFOR & G-CSF"},{"description":"Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.\n\nPlerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.\n\nbortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)\n\nPlerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)","id":"OG004","title":"Arm E: PLERIXAFOR, VELCADE, & G-CSF"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Data analyzed only for patients who went on to receive a stem cell transplant after mobilization. 25 subject did not receive a stem cell transplant after mobilization and therefore are not included in the analysis.","reportingStatus":"POSTED","timeFrame":"20 days post-transplant","title":"Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant","type":"SECONDARY","unitOfMeasure":"Participants"}