{"denoms":[{"counts":[{"groupId":"BG000","value":"55"}],"units":"Participants"}],"groups":[{"description":"Carfilzomib (intravenous (IV), Days 1, 2, 8, 9, 15, and 16 of the 28-day cycle); Revlimid (by mouth (PO), Days 1-21 of the 28-day cycle; exception: not given on cycle 1 day 1); and Dexamethasone (PO or IV, Days 1, 2, 8, 9, 15, 16, 22, and 23 of the 28-day cycle; exception: not given on cycle 1 day 1)\n\nCarfilzomib intravenous (IV) 20-36 mg/m\\^2 per dose on days 1, 2, 8, 9, 15, and 16 of each cycle based on arm; until disease progression or unacceptable toxicity.\n\nRevlimid by mouth (PO) 25 mg/day, days 1-21 every 28 days of each cycle based on arm; until disease progression or unacceptable toxicity.","id":"BG000","title":"All Participants"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"40"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"15"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"8","value":"60.83"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"24"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"31"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"53"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Unknown or Not Reported"}]}],"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":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"38"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}],"title":"Northeast"},{"measurements":[{"groupId":"BG000","value":"28"}],"title":"Southeast"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Southwest"},{"measurements":[{"groupId":"BG000","value":"4"}],"title":"West"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Missing"}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"20"}]}],"title":"High Risk"},{"categories":[{"measurements":[{"groupId":"BG000","value":"27"}]}],"title":"Standard Risk"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"}]}],"title":"Unknown"}],"description":"High risk cytogenetics was defined as del17p,t(14;16), t(14;20), and 1q gain. These cytogenetic abnormalities identified by fluorescence in situ hybridization (FISH) confer a worse prognosis. Per the International Myeloma Working Group (IMWG), participants with high risk cytogenetics may have impaired response to treatment and worse overall survival (OS).","paramType":"COUNT_OF_PARTICIPANTS","title":"Cytogenetic Risk Group","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10"}]}]}],"description":"This trial was for high risk smoldering myeloma participants.These participants were enrolled before the updated definition of multiple myeloma, Myeloma-defining events include ≥60% bone marrow plasmacytosis, serum-free light chain ratio≥100, \\&/or\\>1 focal lesion on magnetic resonance imaging. Between the time of initial enrollment in 2013, the definition of smoldering myeloma was changed to exclude participants with the listed myeloma defining events. The 10 participants in our cohort of high risk smoldering myeloma would be classified as having \"full multiple myeloma\" by today's definition.","paramType":"NUMBER","title":"Myeloma-defining event per International Myeloma Working Group (IMWG) 2014","unitOfMeasure":"events"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36"}]}]}],"description":"High-risk is defined by immunoparesis ≥95% aberrant plasma cells on bone marrow aspirate flow cytometry Programa de Estudio y Tratamiento de las Hemopatías Malignas (PETHEMA). This is just one high risk criteria. Neither good nor bad for the participant.","paramType":"COUNT_OF_PARTICIPANTS","title":"High-risk Smoldering Multiple Myeloma by Programa de Estudio y Tratamiento de las Hemopatías Maligna","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}]}],"description":"High-risk is defined by a serum-free light chain ratio of 8 or 0.125 (Mayo Clinic 2008) or 2-3 of the following: serumMprotein \\>2 g/dL, involved to uninvolved free light chain ratio \\>20, or bone marrow plasmacytosis \\>20%. This is just one high risk criteria. Neither good nor bad for the participant.","paramType":"COUNT_OF_PARTICIPANTS","title":"Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2008","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36"}]}]}],"description":"These participants were enrolled before the updated definition of multiple myeloma, Myeloma-defining events include ≥60% bone marrow plasmacytosis, serum-free light chain ratio ≥100, and/or \\>1 focal lesion on magnetic resonance imaging. This is just one high risk criteria. Neither good nor bad for the participant.","paramType":"COUNT_OF_PARTICIPANTS","title":"Number of Participants with High-Risk Smoldering Multiple Myeloma (SMM) by Mayo Clinic 2018","unitOfMeasure":"Participants"}]}