{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}],"title":"Recommended dose reached"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"1"}],"title":"Patients treated at lower dose levels"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}],"title":"Extended Cohort performed"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"}],"units":"Participants"}],"description":"Safety profile: acute, short and middle term toxicities Recommended Dose for Phase-2 (RDP2) and Extended Cohort for 14 patients at this dose","groups":[{"description":"Cohort 1: Total Bone Marrow Irradiation (TBMI): 8 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3.\n\nMelphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics.\n\nAutologous Peripheral Stem Cell Rescue: re-infused in the central line on day \"0\" after adequate premedication.","id":"OG000","title":"Total Bone Marrow Irradiation (TBMI): 8 Gy"},{"description":"Cohort 2: Total Bone Marrow Irradiation (TBMI): 10 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3.\n\nMelphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics.\n\nAutologous Peripheral Stem Cell Rescue: re-infused in the central line on day \"0\" after adequate premedication.","id":"OG001","title":"Total Bone Marrow Irradiation (TBMI): 10 Gy"},{"description":"Cohort 3: Total Bone Marrow Irradiation (TBMI): 12 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3.\n\nMelphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics.\n\nAutologous Peripheral Stem Cell Rescue: re-infused in the central line on day \"0\" after adequate premedication.","id":"OG002","title":"Total Bone Marrow Irradiation (TBMI): 12 Gy"},{"description":"Cohort 4: Total Bone Marrow Irradiation (TBMI): 14 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3.\n\nMelphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics.\n\nAutologous Peripheral Stem Cell Rescue: re-infused in the central line on day \"0\" after adequate premedication.","id":"OG003","title":"Total Bone Marrow Irradiation (TBMI): 14 Gy"},{"description":"Cohort 5: Total Bone Marrow Irradiation (TBMI): 16 Gy delivered by the Tomotherapy HI-ART machine, in 2 fractions per day during 4 consecutive days from d -6 to d -3.\n\nMelphalan 140 mg/m² infused intravenously during 30 minutes on day -2 after IV anti-emetics.\n\nAutologous Peripheral Stem Cell Rescue: re-infused in the central line on day \"0\" after adequate premedication.","id":"OG004","title":"Total Bone Marrow Irradiation (TBMI): 16 Gy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The study was terminated prematurely, due to a lack of enrolments. The recommended dose for phase-2 has not been reached. No extended cohort has been performed","reportingStatus":"POSTED","timeFrame":"1 year","title":"Safety Profile Recommended Dose for Phase-2 (RDP2)","type":"SECONDARY","unitOfMeasure":"Participants"}