{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}],"title":"Complete Response (CR)"},{"measurements":[{"groupId":"OG000","value":"13"}],"title":"Very Good Partial Response (VGPR)"},{"measurements":[{"groupId":"OG000","value":"2"}],"title":"Partial Response (PR)"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"Stable Disease (SD)"},{"measurements":[{"groupId":"OG000","value":"1"}],"title":"Progressive Disease (PD)"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"22"}],"units":"Participants"}],"description":"Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).\n\nAll participants were able to tolerate study treatment.\n\nPer protocol, overall response designations are a combination of hematologic response.\n\nA CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\\* to \\<40 mg/L, a PR is dFLC reduction by \\>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \\>100 mg/L.\n\n\\* \"dFLC\" is difference in involved and uninvolved serum Free Light-Chain levels.","groups":[{"description":"Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles.\n\nDaratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.","id":"OG000","title":"Daratumumab"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"3 months","title":"Assess the Number of Patients Who Respond to Treatment","type":"PRIMARY","unitOfMeasure":"Participants"}