{"denoms":[{"counts":[{"groupId":"OG000","value":"0"}],"units":"Participants"}],"description":"Toxicity will be scored using CTCAE version 3.0 for toxicity and adverse event reporting.\n\nProgressive Disease: requires any one or more of the following:\n\n1. Increase of ≥25% from baseline in Serum M-component and/or (the absolute increase must be ≥0.5 g/dl)b\n2. Urine M-component and/or (the absolute increase must be ≥200 mg/24 h\n3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels. The absolute increase must be \\>10 mg/dl.\n4. Bone marrow plasma cell percentage: the absolute % must be ≥10%c\n5. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas\n6. Development of hypercalcemia (corrected serum calcium \\>11.5 mg/dl or 2.65 mmol/l) that can be attributed solely to the plasma cell proliferative disorder","groups":[{"description":"Treatment phase (28 days/cycle x 6 cycles):\n\nLenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.\n\nMaintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):\n\nlenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles.","id":"OG000","title":"ReMeDex"}],"populationDescription":"No data are available because data were not collected. Pi left the institution and slow accrual did not allow for sufficient data collection prior to PI leaving institution. No data were analyzed.","reportingStatus":"POSTED","timeFrame":"every 28 days during therapy and every month after therapy for 2 years","title":"Toxicity, Time to Progression & Progression Free Survival","type":"PRIMARY"}