{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0","upperLimit":"148","value":"85.28"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"148","value":"69.3"},{"groupId":"OG002","lowerLimit":"0","upperLimit":"148","value":"81.5"},{"groupId":"OG003","lowerLimit":"0","upperLimit":"148","value":"70.13"},{"groupId":"OG004","lowerLimit":"0","upperLimit":"148","value":"80.14"},{"groupId":"OG005","lowerLimit":"0","upperLimit":"148","value":"79.33"},{"groupId":"OG006","lowerLimit":"0","upperLimit":"148","value":"74.68"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"21"}],"units":"Participants"}],"description":"quality of life will be evaluated and scored using the questionnaire from the bone marrow transplant subscale of the Functional Assessment of Cancer Therapy available from w ww.facit.org. The FACT-BMT is a 50 item questionnaire that measures five dimensions of quality of life in bone marrow transplant patients, including physical well-being, social and family well-being, emotional well-being, functional well-being, and additional concerns. It is scored on a 5 point Likert scale. Total scores range from 0 to 148, with a higher score indicating higher quality of life.","dispersionType":"Full Range","groups":[{"description":"Oral lenalidomide 25mg twice daily x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG000","title":"Phase 1 Dose Level 1"},{"description":"Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG001","title":"Phase 1 Dose Level 2"},{"description":"Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG002","title":"Phase 1 Dose Level 3"},{"description":"Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG003","title":"Phase 1 Dose Level 4"},{"description":"Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG004","title":"Phase 1 Dose Level 5"},{"description":"Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG005","title":"Phase 1 Dose Level 6"},{"description":"Early studies noted a dose response relationship and found myelosuppression to be the dose limiting toxicity. In this Phase 1 study of high dose lenalidomide (HDLEN) with HDM in conditioning for ASCT shown no DLT noted up to 350mg PO daily of LEN.\n\nIn Phase 2, HDLEN was dosed at 350mg PO daily from day -5 to day -1 and HDM was dosed 100mg/m2 on days -2 and -1.\n\nAfter a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"OG006","title":"Phase 2 Expansion"}],"paramType":"MEAN","populationDescription":"Subjects from whom data were not collected were excluded from analysis.","reportingStatus":"POSTED","timeFrame":"Cycle 6, day 1, at approximately 4.5 months","title":"Mean Functional Assessment of of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Score","type":"SECONDARY","unitOfMeasure":"score on a scale"}