{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"}],"units":"Participants"}],"description":"Overall Response Rate= Minor response (\\>25%-50% reduction in serum IgM from baseline) + Partial Response (\\>50-90% reduction in serum IgM from baseline) + Very Good Partial Response (\\>90% reduction in serum IgM from baseline) + Complete Response (resolution of all symptoms, normalization of serum IgM with disappearance of IgM paraprotein, resolution of any adenopathy or splenomegaly).","groups":[{"description":"* Daratumumab will be administered in three phases: Induction, consolidation and maintenance\n* During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day\n* During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle\n* During maintenance, daratumumab will be administered on day 1 of each 28-day cycle\n\nDaratumumab: Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories","id":"OG000","title":"Daratumumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Only participants who have measurable disease present at baseline, received at least one cycle of therapy, and had their disease re-evaluated were considered evaluable for response. 2 participants did not complete the first cycle of therapy and were unevaluable for the primary objective.","reportingStatus":"POSTED","timeFrame":"2 years","title":"Overall Response Rate","type":"PRIMARY","unitOfMeasure":"Participants"}