{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Grade 4 Mucositis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Grade 4 non-hematologic or non-infectious toxicity"}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"27"}],"units":"Participants"}],"description":"Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.","groups":[{"description":"PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.\n\nTRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.\n\nPOST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\\^9/L.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo HSCT\n\nFilgrastim-sndz: Given SC\n\nMelphalan Hydrochloride: Given IV","id":"OG000","title":"Group1_Dose 1 200mgm2"},{"description":"PREPARATIVE REGIMEN: Participants receive melphalan IV over 30-60 minutes on day -2.\n\nTRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.\n\nPOST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\\^9/L.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo HSCT\n\nFilgrastim-sndz: Given SC\n\nMelphalan Hydrochloride: Given IV","id":"OG001","title":"Group 1_Dose 2 225mgm2"},{"description":"PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.\n\nTRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.\n\nPOST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\\^9/L.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo HSCT\n\nFilgrastim-sndz: Given SC\n\nMelphalan Hydrochloride: Given IV","id":"OG002","title":"Group 2_Dose 1 200mgm2"},{"description":"PREPARATIVE REGIMEN: Participants receive melphalan IV over 8-9 hours on day -2.\n\nTRANSPLANT: Participants in both groups undergo donor stem cell transplantation IV on day 0 over 30-60 minutes.\n\nPOST-TRANSPLANT: Participants in both groups receive filgrastim-sndz SC QD starting on day 5 and continuing in the absence of disease progression, unacceptable toxicity, or until evidence of an ANC of 0.5 x 10\\^9/L.\n\nAutologous Hematopoietic Stem Cell Transplantation: Undergo HSCT\n\nFilgrastim-sndz: Given SC\n\nMelphalan Hydrochloride: Given IV","id":"OG003","title":"Group 2_Dose 225mgm2"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Within 30 days after the start of infusion","title":"Optimal Dose and Schedule of Evomela Prior to Autologous Transplant.","type":"PRIMARY","unitOfMeasure":"Participants"}