{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Anti-tumor effect will be assessed based on serum protein electrophoresis (SPEP) of the monoclonal protein (M-protein) and plasma concentrations of K/L free light chains (FLC) after each 28-day cycle. Descriptive statistics will be used for this measurement.\n\nComplete response (CR): disappearance of any M-protein and FLC as measured by SPEP and/or FLC. Pre-existing plasmacytomas must have completely resolved.\n\nPartial response (PR): \\>50% reduction in M-protein and \\>50% reduction in the difference between involved and uninvolved FLC. Any plasmacytoma must have decreased in size by \\>50%.\n\nStable disease: not meeting criteria for CR, PR, or progressive disease (PD). PD: \\>25% increase from baseline in serum or urine M-protein (serum M-protein must increase by \\> 0.5 gm/dl; urine M-protein must increase by \\>200 mg /24 hr); or development of new plasmacytomas or new lytic bone lesions; or a measurable increase in the size of these lesions; or hypercalcemia (\\>11.5 mg/dl) attributed to MM.","groups":[{"description":"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg \\>75yrs) orally, days 1, 8,15, 22 of a 28 day cycle\n\nCombination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.\n\nCycles will span 28 days. Dosage schedules will be:\n\n1. Everolimus daily for 28 days of a 28 day cycle;\n2. Pomalidomide daily for 21 days of a 28 day cycle\n3. Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle.","id":"OG000","title":"Combination Therapy"}],"populationDescription":"There was only one patient enrolled. Anti-tumor effect cannot be reported accurately based on results from one patient.","reportingStatus":"POSTED","timeFrame":"3.5 years","title":"Anti-tumor Effect","type":"SECONDARY"}