{"denoms":[{"counts":[{"groupId":"BG000","value":"10"}],"units":"Participants"}],"groups":[{"description":"Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.","id":"BG000","title":"Experimental"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"8"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"43","upperLimit":"72","value":"59"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"White"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"Other"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}],"title":"Spain"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}],"title":"PS 0"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"PS 1"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"PS 2"}]}],"description":"ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG PS","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Secretory IgA"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Secretory IgG"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Secretory Kappa light-chain disease"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Secretory Lambda light-chain disease"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Multiple myeloma type at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"IIA"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"IIIA"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"IIIB"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Missing"}]}],"description":"4 patients had missing data in stage and sub-classification Stage I: All of the following: Hemoglobin\\>10 g/dl,Serum calcium\\<10.5 mg/dL, normal bone structure,IgG\\<5 g/dL; IgA\\<3 g/dL, Urine light chain M-component\\<4 g/24h Stage II:Fitting neither Stage I nor Stage III Stage III: One or more of the following: Hemoglobin\\<8.5 g/dL, Serum calcium\\>12 mg/dL,Advanced lytic bone lesions,IgG\\>7 g/dL; IgA\\> 5 g/dL,Urine light chain M-component\\>12 g/24h Subclassification: A, serum creatinine\\<2.0 mg/dL;B, serum creatinine\\>2.0 mg/dL","paramType":"COUNT_OF_PARTICIPANTS","title":"Durie-Salmon stage and subclassification at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"ISS I"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"ISS II"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"ISS III"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Not done"}]}],"description":"ISS, International Staging System ISS stage I was defined as serum β2-microglobulin level less than 3.5 mg/L and serum albumin level ≥ 3.5 g/dL. ISS stage II included all patients with neither stage I nor stage III disease. ISS stage III was defined as serum β2-microglobulin level ≥ 5.5 mg/L, irrespective of serum albumin level","paramType":"COUNT_OF_PARTICIPANTS","title":"ISS stage at diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Stage III"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Non available genetic results"}]}],"description":"R-ISS, Revised International Staging System Stage I: Serum β2 microglobulin\\<3.5 mg/l; Serum albumin≥3.5 g/dl;Standard-risk chromosomal abnormalities (CA);Normal LDH Stage II: Not R-ISS stage I or III Stage III: Serum β2 microglobulin≥5.5 mg/L and either High-risk CA by FISH OR High LDH","paramType":"COUNT_OF_PARTICIPANTS","title":"R-ISS stage at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"High risk"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Standard risk"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Non available genetic results"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Cytogenetic at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}],"title":"Primary Refractory"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Relapsed and refractory"}]}],"description":"Total refractory MM included 2 categories of refractory:\n\n* Primary Refractory: disease that was non-responsive in patients who had never achieved a MR or better, with any therapy. It included patients who never achieved MR or better, in whom there was no significant change in M-protein and no evidence of clinical progression, as well as primary, refractory PD where patients met criteria for true PD.\n* Relapsed and refractory: disease that was non-responsive while on salvage therapy, or progressed within 60 days of the last therapy in patients who had achieved MR or better at some point","paramType":"COUNT_OF_PARTICIPANTS","title":"Disease status with respect to last prior therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"PR"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"MR"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"SD"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"PD"}]}],"description":"Partial response (PR): had ≥50% reduction in serum M-protein and reduction of 24-hour urine M-protein by 90% or to \\<200 mg/24h Minimal response (MR): had ≥25% but ≤49% reduction of serum M-protein and reduction of 24h urine M-protein 50-89%.\n\nProgressive disease (PD): had a 25% increase from the lowest response value in any of the following: serum M-protein, urine M-protein, BM plasma cell percentage, or difference in the kappa and lambda FLC. PD also diagnosed when an increase size or new bone lesions Stable disease (SD): not meet the criteria for PR, MR or PD","paramType":"COUNT_OF_PARTICIPANTS","title":"Best response to last prior anticancer therapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Autologous"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Autologous and allogenic"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"No"}]}],"description":"HSCT, hematopoietic stem cell transplantation","paramType":"COUNT_OF_PARTICIPANTS","title":"Prior HSCT","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"}],"title":"3 lines"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"4 lines"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"5 lines"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"8 lines"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"9 lines"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Lines of prior chemotherapy","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"51.0","upperLimit":"105.3","value":"71.4"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Weight","unitOfMeasure":"kg"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"152","upperLimit":"186","value":"167.1"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Height","unitOfMeasure":"cm"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.5","upperLimit":"2.2","value":"1.8"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Body surface area","unitOfMeasure":"m^2"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"16","upperLimit":"168","value":"70.7"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time from diagnosis to first plitidepsin infusion","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"2","upperLimit":"14","value":"5.3"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time from last progressive disease to first infusion","unitOfMeasure":"weeks"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"3","upperLimit":"9","value":"5"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Lines of prior chemotherapy","unitOfMeasure":"Lines"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"5","upperLimit":"13","value":"9"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Agents of prior chemotherapy","unitOfMeasure":"Agents"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.6","upperLimit":"10.6","value":"3.4"}]}]}],"description":"Time to progression (TTP) was defined as the time, in months, from the date of the first infusion of last anticancer therapy to the date of documented PD previous study entry.","dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"TTP to last anticancer therapy","unitOfMeasure":"months"}]}