{"groups":[{"description":"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will undergo leukapheresis and then will receive maintenance lenalidomide with myeloma vaccine and GM-CSF.\n\nTumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell will be isolated and frozen for subsequent vaccine generation.\n\nAutologous Stem Cell Transplant: Patients will receive an autologous graft of a minimum cell dose of 2.0 x 10\\^6 CD34+ cells/kg patient actual body weight per transplantation with high-dose melphalan of 200mg/m\\^2 at the schedule and timing according to institutional practices.\n\nLeukapheresis: Blood samples will be collected through a catheter in the neck or chest and leukapheresis will be performed using standard clinical procedures.\n\nLenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.\n\nMyeloma vaccine: The target dose is 3 x 10\\^6 fusion cells per vaccine. A minimum of 3 x 10\\^6 total fusion cells will be required to proceed with vaccine administration. Patients will receive the DC/MM fusion vaccine on day 1 of cycles 2, 3, and 4 of lenalidomide maintenance.\n\nGM-CSF: 100 ug GM-CSF will be given for a total of 4 days of each cycle.","id":"FG000","title":"Lenalidomide, Vaccine, and GM-CSF"},{"description":"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide with GM-CSF.\n\nTumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).\n\nAutologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.\n\nMelphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\\^2 at the schedule and timing according to institutional practices.\n\nLenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.\n\nGM-CSF: 100 ug GM-CSF will be given subcutaneously in the upper thigh and daily for a total of 4 days of each cycle.","id":"FG001","title":"Lenalidomide and GM-CSF"},{"description":"Patients will undergo tumor cell collection and autologous stem cell transplant with melphalan. Patients will receive maintenance lenalidomide.\n\nTumor Cell Collection: Patients will undergo aspiration of 30 mL of bone marrow from which myeloma cell preparations will be generated. Myeloma cells will be isolated and frozen for subsequent vaccine generation for patients randomized to the vaccine arm (randomization occurs after transplant and recovery).\n\nAutologous Stem Cell Transplant: Patients will receive an autologous graft with a minimum cell dose of 2.0 x 10\\^6 CD34+ cells/kg patient actual body weight per autologous transplantation.\n\nMelphalan: Autologous hematopoietic cell transplant will be done with high-dose melphalan of 200mg/m\\^2 at the schedule and timing according to institutional practices.\n\nLenalidomide: Maintenance therapy with lenalidomide will begin between 90 and 100 days after stem cell infusion. Lenalidomide will be administered initially at a dose of 10 mg per day continuously. Cycle duration during maintenance therapy is 28 days. Patients will continue lenalidomide for two years from initiation of therapy.","id":"FG002","title":"Maintenance Lenalidomide"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Investigational study drug permanently discontinued"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Covid"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"68"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"35"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"30"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Sixty-three participants dropped out of the study prior to randomization and 140 participants received a transplant and proceeded to randomization. The reasons for dropout include insufficient tumor cells collected (n=13), withdrew consent from study (n=12), ineligible to be randomized (n=8), disease progression prior to randomization (n=6), refused or did not make it to transplantation (n=10), physician decision (n=7), manufacturing failure (n=4), lost to follow up (n=2), and insurance (n=1).","recruitmentDetails":"The study opened to accrual on July 25, 2016 and closed to accrual on October 12, 2018 with 203 participants enrolled from 18 participating centers. The final study database lock was done September 9, 2021."}