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For 28-day cycles until progression or intolerance","id":"BG001","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":"BG002","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":"BG003","title":"ARM Pom-cyclo-dex Late (B-II)"},{"description":"Total of all reporting groups","id":"BG004","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"5"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"43","upperLimit":"79","value":"54"},{"groupId":"BG001","lowerLimit":"68","upperLimit":"68","value":"68"},{"groupId":"BG002","lowerLimit":"52","upperLimit":"67","value":"59.5"},{"groupId":"BG003","lowerLimit":"60","upperLimit":"60","value":"60"},{"groupId":"BG004","lowerLimit":"43","upperLimit":"79","value":"60"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"6"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"8"}]}],"title":"Caucasian"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"8"}]}],"title":"Italy"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"5"}]}],"title":"0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"3"}]}],"title":"1"}],"description":"ECOG 0-5; the best is 0, 5 is death","paramType":"NUMBER","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"7"}]}],"title":"IgG"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]}],"title":"Bj"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"isotype","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"6"}]}],"title":"I"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"2"}]}],"title":"II"}],"description":"International Staging System (ISS) for Multiple Myeloma Stage VALUES (β2M = Serum β2 microglobulin; ALB = serum albumin I β2M \\< 3.5 mg/L; ALB ≥ 3.5 g/dL II β2M \\< 3.5 mg/L; ALB ≥ 3.5 g/dL; or β2M 3.5 - 5.5 mg/L III β2M \\> 5.5 mg/L I low risk, II medium risk, III high risk","paramType":"COUNT_OF_PARTICIPANTS","title":"International Staging System (ISS) Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"7"}]}],"title":"ASCT"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"7"}]}],"title":"Len"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"4"}]}],"title":"Bort"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Previous Therapies (induction/Autologous Stem Cell Transplantation/consolidation)","unitOfMeasure":"Participants"}],"populationDescription":"This analysis included only patients in whom CPd vs Pd randomization was disclosed; 1pt randomized to Late (II) treatment who not achieved a CRAB has not the disclosure of the randomization between A vs B arm.."}