{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Complete Response (CR) rate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.6"}]}],"title":"Very Good Partial Response (VGPR) Rate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7.6"}]}],"title":"Total CR + VGPR"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15.4"}]}],"title":"Partial Response (PR) Rate"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"}]}],"title":"Overall Response Rate (ORR = CR + VGPR + PR)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"13"}],"units":"Participants"}],"description":"Modified International Myeloma Working Group Uniform Response Criteria:\n\nComplete (CR)=\n\n* Negative for monoclonal protein (MP) in urine (U) and serum (S) +\n* No tissue plasmacytomas (PC) +\n* \\<5% plasma cells (PCs) in marrow (M)\n\nStringent CR (sCR)= CR with normal light chain ratio+ no PCs in M\n\nNear CR (nCR)= CR, except MP persists in U and S\n\nPartial (PR)= S MP ≤50%, + U MP ≤90% or \\<200 mg/24 hours (hr)\n\nVery Good PR (VGPR)= in S MP ≤90%, + U MP \\<100 mg/24 hr\n\nMinimal (MR)=\n\n* S MP ≤51-75%, +\n* If light chain is excreted, reduced 50-89%/24 hr that is also \\>200 mg/24 hr, +\n* No increase in lytic bone lesions\n\nProgressive disease (PD)= any of:\n\n* S MP ≥125% and/or ≥+0.5 g/dL,\n* U MP ≥125% and/or ≥+200 mg/24 hr\n* New or increased bone lesions/PC\n* S calcium \\>11.5 mg/dL (attributed to increased PCs)\n\nPD after CR/sCR=\n\n* Reappearance of S or U MP\n* ≥5% clonal PCs in M\n* New PC, lytic bone lesions, hypercalcemia\n\nStable Disease (SD)= Not CR, VGPR, MR, PR, or PD","groups":[{"description":"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.\n\nConcurrent therapeutic medications:\n\n* Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14\n* Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)\n\nOther drugs:\n\n* Aspirin: 81 or 325 mg daily oral\n* Pegfilgrastim subcutaneous on Day 2","id":"OG000","title":"Amrubicin + Lenalidomide + Dexamethasone"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"12 weeks","title":"Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria","type":"PRIMARY","unitOfMeasure":"percentage of participants"}