{"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"groups":[{"description":"Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle.\n\nMelphalan flufenamide (Melflufen)\n\nDexamethasone","id":"BG000","title":"Melphalan Flufenamide (Melflufen) + Dexamethasone"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"78"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"79"}],"title":">=65 years"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"9.63","value":"64.7"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"89"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"68"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"137"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"11"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"132"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"12"}],"title":"Unknown or Not Reported"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"69"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"23"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"52"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"Spain"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"39"}],"title":"Performance Status 0"},{"measurements":[{"groupId":"BG000","value":"93"}],"title":"Performance Status 1"},{"measurements":[{"groupId":"BG000","value":"24"}],"title":"Performance Status 2"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Performance Status 3"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"description":"ECOG Performance Status Categories Status 0: Normal activity, fully active, able to carry on all pre-disease performance without restriction.\n\nStatus 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).\n\nStatus 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.\n\nStatus 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours.","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"17.41","value":"74.3"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"156"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","populationDescription":"Baseline weight not recorded for one patient","title":"Weight","unitOfMeasure":"kilograms"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"63"}],"title":"International Staging System (ISS) Stage I"},{"measurements":[{"groupId":"BG000","value":"49"}],"title":"International Staging System (ISS) Stage II"},{"measurements":[{"groupId":"BG000","value":"39"}],"title":"International Staging System (ISS) Stage III"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"Unknown"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"description":"International Staging System (ISS) is an assessment of risk factors for multiple myeloma ISS Stage I: Serum B2-microglobulin \\< 3.5 mg/L, serum albumin ≥ 3.5 g/dL ISS Stage II: Not ISS Stage I or III ISS Stage III: Serum B 2-microglobulin ≥ 5.5 mg/L","paramType":"COUNT_OF_PARTICIPANTS","title":"International Staging System (ISS)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"3.46","value":"7.0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Time since initial diagnosis","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"55"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Extramedullary disease at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"33"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"SPEP and UPEP"},{"categories":[{"measurements":[{"groupId":"BG000","value":"63"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"SPEP only"},{"categories":[{"measurements":[{"groupId":"BG000","value":"37"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"UPEP only"},{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"sFLC only"},{"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}],"title":"Unable to determine"}],"description":"Serum M-protein ≥ 0.5 g/dL (SPEP), urine M-protein ≥ 200 mg/24 hours (UPEP), or serum free light chain (sFLC) assay with FLC ≥ 10 mg/dL (≥ 100 mg/L) and abnormal serum immunoglobulin kappa to lambda FLC ratio.","paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"5 patients did not have all assessments completed to adequately categorize","title":"Type of measurable disease at baseline","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59"}],"title":"High"},{"measurements":[{"groupId":"BG000","value":"67"}],"title":"Standard"},{"measurements":[{"groupId":"BG000","value":"31"}],"title":"Unknown"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"description":"High-risk cytogenetic abnormalities at study entry is defined as patients who had the genetic subtype t(4; 14), t(14:16), deletion 17p, gain 1q (+1q), or t(14,20) determined by Baseline fluorescence in situ hybridization (FISH)","paramType":"COUNT_OF_PARTICIPANTS","title":"Cytogenetic risk group based on FISH at study entry","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18"}],"title":"IgA-Kappa"},{"measurements":[{"groupId":"BG000","value":"12"}],"title":"IgA-Lambda"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"IgD-Kappa"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"IgD-Lambda"},{"measurements":[{"groupId":"BG000","value":"57"}],"title":"IgG-Kappa"},{"measurements":[{"groupId":"BG000","value":"31"}],"title":"IgG-Lambda"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"IgM-Kappa"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Multiple-Kappa"},{"measurements":[{"groupId":"BG000","value":"19"}],"title":"None-Kappa"},{"measurements":[{"groupId":"BG000","value":"13"}],"title":"None-Lambda"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Unknown-Kappa"}],"denoms":[{"counts":[{"groupId":"BG000","value":"157"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Heavy-light chain combination at study entry","unitOfMeasure":"Participants"}]}