{"analyses":[{"ciLowerLimit":"-0.32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.28","groupDescription":"Arm B was initially closed due to low accrual, and Arms D and E were also closed due to no accrual. Arms A and C also had very low accrual. Therefore, the comparison of the primary outcome between Arms A and C is for exploratory purposes only.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.90","paramType":"Risk Difference (RD)","paramValue":"-0.02","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"14"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"description":"The primary endpoint in all five treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness). Note that no patients were enrolled Arm D and Arm E.","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":"Arm A: 20 patients were enrolled but only 17 were evaluable. Arm C: 23 patients enrolled but only 21 were evaluable. Arm D and Arm E of the study did not accrue any subjects, therefore the number of participants analyzed for this outcome measure is 0 for both arms.","reportingStatus":"POSTED","timeFrame":"36 months","title":"Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.","type":"PRIMARY","unitOfMeasure":"Participants"}