{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.5"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15.9"}]}],"title":"Partial Response (PR)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"82"}],"units":"Participants"}],"description":"A confirmed response is defined to be a CR or PR noted as the objective status for eligible patients during cycles 1-12.\n\nComplete Response (CR):\n\n* Multiple Myeloma (MM): Negative immunofixation of serum and urine, disappearance of soft tissue plasmacytomas, and normalization of free light chain (FLC) ratio.\n* Lymphoma: Disappearance of all clinical and radiographic evidence of disease, all lymph nodes of normal size (1.5 cm or less), no splenomegaly.\n\nPartial Response (PR):\n\n* MM: 50% reduction of serum or urine M-protein or to less than 200mg/day, a 50% reduction in the difference between involved and uninvolved FLC, and 50% reduction in the size of soft tissue plasmacytoma.\n* Lymphoma: 50% or greater reduction in sum of the products of the dimension for nodal masses; no increase in liver, spleen or node size; no new sites of disease; and a 50% decrease in lymphocyte count if followed at baseline.","groups":[{"description":"This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II.\n\nTherefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).","id":"OG000","title":"Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 12 cycles of treatment","title":"Proportion of Confirmed Tumor Responses","type":"PRIMARY","unitOfMeasure":"percentage of participants"}