{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"}]}],"title":"Within 3 cycles"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"}]}],"title":"At the end of cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"}]}],"title":"Within 6 cycles"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"}]}],"title":"At the end of cycle 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"Participant clonal response rate within 3 months, at 3 months, within 6 months and at 6 months will be assessed. The percentage of participants who achieve at least a partial response will be reported.\n\nClonal response is defined as:\n\nCR: Negative immunofixation of serum and urine (serum alone in anuric patients) AND normal FLC concentration and kappa/lambda FLC ratio (FLC ratio alone in renal failure) AND ≤5% plasma cells in bone marrow without clonality by immunohistochemistry or immunofluorescencea\n\nVGPR: \\>90% reduction in serum paraprotein or abnormal component of FLC or dFLC over the starting value or dFLC \\<40mg/L\n\nPR: ≥50% decrease in aberrant FLC concentration or dFLC (or ≥50% decrease in dFLC if renal failure) or serum paraprotein but not fulfilling criteria for CR or VGPR\n\nMR: \\>25% but \\<50% decrease in aberrant FLC or dFLC or paraprotein\n\nNR: Not meeting FLC criteria for CR, PR or MR","groups":[{"description":"All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.","id":"OG000","title":"Dose Level 0- Safety Population"},{"description":"All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.","id":"OG001","title":"Dose Level 1- Safety Population"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Within 3 months, at 3 months, within 6 months and at 6 months","title":"Clonal Response Rate Within 3 Months, at 3 Months, Within 6 Months and at 6 Months as Determined by Paraprotein and Free Light Chain Assessment.","type":"SECONDARY","unitOfMeasure":"Participants"}