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Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"147","upperLimit":"181","value":"165.0"},{"groupId":"BG001","lowerLimit":"155","upperLimit":"189","value":"169.0"},{"groupId":"BG002","lowerLimit":"167","upperLimit":"180","value":"172.5"},{"groupId":"BG003","lowerLimit":"147","upperLimit":"189","value":"168.0"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Baseline height","unitOfMeasure":"cm"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"57.3","upperLimit":"132.0","value":"73.00"},{"groupId":"BG001","lowerLimit":"54.0","upperLimit":"140.0","value":"75.25"},{"groupId":"BG002","lowerLimit":"73.0","upperLimit":"110.0","value":"85.50"},{"groupId":"BG003","lowerLimit":"54.0","upperLimit":"140.0","value":"74.00"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Baseline weight","unitOfMeasure":"kg"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"17"}],"title":"score = 0"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"15"}],"title":"score = 1"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}],"title":"score = 2"}]}],"description":"ECOG Performance Scale:\n\n0=Normal activity, fully active, able to carry on all pre-disease performance without restriction. 1=Symptoms, but fully ambulatory, restricted in physically strenuous but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.","paramType":"COUNT_OF_PARTICIPANTS","title":"Baseline Eastern Cooperative Oncology Group (ECOG) score","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}],"title":"stage I"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"14"}],"title":"stage II"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"18"}],"title":"stage III"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"unknown"}]}],"description":"ISS Stage Stage I: Serum B2-microglobulin \\<3.5 mg/L; serum albumin \\>=3.5 g/dL Stage II: Not ISS Stage I or III. Stage III: Serum B2-microglobulin \\>=5.5mg/L R-ISS Stage Stage I: ISS Stage I and standard risk chromosomal abnormalities (CA) by interphase by florescent in situ hybridization (iFISH) \\& normal lactate dehydrogenase (LDH) Stage II: Not R-ISS Stage I or III Stage III: ISS Stage III \\& either high risk CA by iFISH or high LDH","paramType":"COUNT_OF_PARTICIPANTS","title":"International Staging System (ISS) stage at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"29"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"6"}],"title":"No"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Evidence of lytic bone disease at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"3"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"32"}],"title":"No"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Evidence of extramedullary disease at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"18"}],"title":"Relapsed"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"17"}],"title":"Relapsed-refractory"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Disease status at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"1.1","upperLimit":"11.1","value":"6.47"},{"groupId":"BG001","lowerLimit":"0.9","upperLimit":"8.0","value":"3.82"},{"groupId":"BG002","lowerLimit":"1.6","upperLimit":"7.7","value":"5.13"},{"groupId":"BG003","lowerLimit":"0.9","upperLimit":"11.1","value":"4.78"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time since diagnosis","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"0.5","upperLimit":"9.8","value":"1.12"},{"groupId":"BG001","lowerLimit":"0.6","upperLimit":"5.8","value":"1.49"},{"groupId":"BG002","lowerLimit":"0.9","upperLimit":"9.3","value":"3.29"},{"groupId":"BG003","lowerLimit":"0.5","upperLimit":"9.8","value":"1.25"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Time since most recent relapse/progression","unitOfMeasure":"months"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"6"}],"title":"≥15 to <30 mL/min/1.73m²"},{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"27"}],"title":"≥30 to <45 mL/min/1.73m²"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}],"title":"≥45 mL/min/1.73m²"}]}],"description":"Note that eligibility was based on eGFR measured at Screening, while Baseline measurements are from Cycle 1 Day 1. For some patients, the eGFR value was derived using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula when eGFR was not reported but the corresponding visit serum creatinine value was available.","paramType":"COUNT_OF_PARTICIPANTS","title":"Baseline estimated glomerular filtration rate (eGFR)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"10"}],"title":"High-risk abnormalities"},{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"23"}],"title":"Standard-risk abnormalities"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"}],"title":"Unknown"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"Missing"}]}],"description":"The high-risk based on iFISH is defined in case the following abnormalities were found: deletion (17p), gain 1q (+1q), gain (1q21); t (4;14), t(4;14) (p16;q32), t (14;16), t (14;16) (q32;q23), t(14;20), t(14;20) (q32;q11). The standard-risk based on iFISH consists of patients who have a genetic subtype recorded but none of the genetic subtypes categorized as high-risk based on iFISH. The category of unknown consists of patients for whom the iFISH procedure was not done or unevaluable.","paramType":"COUNT_OF_PARTICIPANTS","title":"Cytogenetics abnormalities by interphase fluorescence in situ hybridization (iFISH) at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"11"}]}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Prior autologous transplant","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"13"}],"title":"2 prior lines of therapy"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"10"}],"title":"3 prior lines of therapy"},{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"12"}],"title":"4 prior lines of therapy"}]}],"description":"There was one patient who reported 2 prior line of therapies but only one of them was multiple myeloma therapy. However, this exception was not reflected in the database since a minimum of 2 lines were possible to report. Although this patient was enrolled into the study incorrectly, the patient was not excluded from analyses.","paramType":"COUNT_OF_PARTICIPANTS","title":"Number of prior systemic therapy lines","unitOfMeasure":"Participants"}],"populationDescription":"Baseline characteristics are shown for the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone."}