{"groups":[{"description":"Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance","id":"FG000","title":"ARM Pom-dex Early (A-I)"},{"description":"Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase.\n\nPomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance","id":"FG001","title":"ARM Pom-dex Late (A-II)"},{"description":"Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance","id":"FG002","title":"ARM Pom-cyclo-dex Early (B-I)"},{"description":"Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase.\n\nPomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance","id":"FG003","title":"ARM Pom-cyclo-dex Late (B-II)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}],"type":"PD"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Closed study by sponsor"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"comment":"Treatment is continous until progression disease (PD), so treatment has not a specific duration and so \"completed\" is Not Applicable.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"For previous reason 1pt randomized to Late (II) treatment who not achieved a CRAB has not the disclosure of the randomization between A vs B arm.","recruitmentDetails":"At enrollment patients was randomized to receive Late (II) vs Early (I) treatment and Pom-Cyclo-dex (B) vs Pom-dex (A) at the same time. If patient was randomized to receive I treatment, the result of the comparison between BvsA was immediately available. Otherwise, in case of II treatment the random disclosure of the comparison between B vs A arm was at the confirmation of CRAB. Patients was randomized using blocks of sizes 12 by the electronic Case Report Form."}