{"groups":[{"description":"Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder \\[equivalent to 50 mg of melphalan free base\\] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.\n\nAlkeran for Injection (single-use glass vial containing melphalan HCl powder \\[equivalent to 50 mg melphalan\\] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.","id":"FG000","title":"Melphalan - Alkeran"},{"description":"Randomized group of Alkeran-Melphalan\n\nAlkeran for Injection (single-use glass vial containing melphalan HCl powder \\[equivalent to 50 mg melphalan\\] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.\n\nMelphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder \\[equivalent to 50 mg of melphalan free base\\] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.","id":"FG001","title":"Alkeran - Melphalan"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Pretreatment (Day -30 to Day -3)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Study Period (Day -3 to Day 0)"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Follow-up(Day +1 to Date of Engraftment)"}],"preAssignmentDetails":"No patients that were enrolled in the study were excluded from the trial prior to assignment to groups.","recruitmentDetails":"The study was conducted at a single study center (University of Kansas Medical Center -two facilities) in the United States under the direction of the investigator, Omar S. Aljitawi, M.D."}