{"denoms":[{"counts":[{"groupId":"BG000","value":"50"}],"units":"Participants"}],"groups":[{"description":"Induction (Cycles 1-9): Lenalidomide orally, days 1-21. Bortezomib injection, days 1, 8, 15, 22. Dexamethasone orally, days 1, 2, 8, 9, 15, 16, 22, 23 (for subjects 75 years of age or younger), or Dexamethasone orally days 1, 8, 15, 22 (for subjects greater than 75 years of age)\n\nConsolidation (cycles 10-15): Lenalidomide po daily (1-21). Bortezomib sc on days 1, 15\n\nLenalidomide\n\nBortezomib\n\nDexamethasone","id":"BG000","title":"Treatment Arm"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"65","upperLimit":"91","value":"73"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"23"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Black or African-American"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Other"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race/Ethnicity, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"}]}],"title":"United States"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19"}],"title":"I"},{"measurements":[{"groupId":"BG000","value":"17"}],"title":"II"},{"measurements":[{"groupId":"BG000","value":"14"}],"title":"III"}]}],"description":"International Staging System for Multiple Myeloma, divides multiple myeloma into three categories with III representing more advanced disease and I less advanced disease\n\nStage I :\n\n* Serum beta-2 microglobulin is less than 3.5 mg/L\n* AND Albumin level is 3.5 g/dL or greater\n* AND Cytogenetics are considered \"not high risk\"\n* AND Lactate dehydrogenase (LDH) levels are normal\n\nStage II: Not stage I or stage II\n\nStage III:\n\n* Serum beta-2 microglobulin is 5.5 (mg/L) or greater\n* AND Cytogenetics are considered \"high-risk\"\n* AND/OR LDH levels are high","paramType":"COUNT_OF_PARTICIPANTS","title":"ISS Stage at Diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"16"}],"title":"I"},{"measurements":[{"groupId":"BG000","value":"16"}],"title":"II"},{"measurements":[{"groupId":"BG000","value":"18"}],"title":"III"}]}],"description":"Stage III represents more advanced disease and stage I less advanced.\n\nStage I:\n\n* Hemoglobin value 10 g/dL\n* Serum calcium value normal or =12 mg/dL\n* Bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only\n* Low M-component production rate (IgG value \\<5 g/dL; IgA value \\<3 g/dL; Bence Jones protein \\<4 g/24 hr)\n\nStage II:\n\nNeither stage I nor stage III\n\nStage III:\n\nOn or more of the following:\n\n* Hemoglobin value 12 mg/dL\n* Advanced lytic bone lesions (scale 3)\n* High M-component production rate - IgG value \\>7 g/dL; IgA value\\>5 g/dL; Bence Jones protein \\>12 g/24 h","paramType":"COUNT_OF_PARTICIPANTS","title":"Durie-Salmon Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"25"}],"title":"0"},{"measurements":[{"groupId":"BG000","value":"18"}],"title":"1"},{"measurements":[{"groupId":"BG000","value":"7"}],"title":"2"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"3"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"4"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"5"}]}],"description":"The Eastern Cooperative Oncology Group (ECOG) Performance Status Score\n\n* 0: Asymptomatic (Fully active, no restrictions in self care)\n* 1: Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature)\n* 2: Symptomatic, \\<50% time in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities)\n* 3: Symptomatic, \\>50% time in bed during waking hours (Capable of only limited self-care)\n* 4: Bedbound (Completely disabled. Cannot carry on any self-care)\n* 5: Death","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Yes"},{"measurements":[{"groupId":"BG000","value":"42"}],"title":"No"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Unknown"}]}],"description":"Cytogenetics risk is determined by doing a genetic analysis of the participants bone marrow. The participants chromosomes are assessed for things like translocations (rearrangement of non-homologous chromosomes) or deletions (part of the genetic sequence is lost). Participants were considered high-risk if they had certain specific genetic changes. Translocations are noted as t(chromosome 1; chromosome 2) where the two chromosomes represent which non homologous chromosomes swapped genetic material. The high-risk cytogenetics included a deletion on chromosome 17, t(4;14), t(14;16), and t(14;20).","paramType":"COUNT_OF_PARTICIPANTS","title":"High-Risk Cytogenetics","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"34"}],"title":"IgG"},{"measurements":[{"groupId":"BG000","value":"9"}],"title":"IgA"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Light-chain only"},{"measurements":[{"groupId":"BG000","value":"2"}],"title":"Unknown"}]}],"description":"The serum heavy/light chain immunoassay quantifies the light chain types of each immunoglobulin (Ig) class based on a sample of the participants blood. Typical antibodies consist of two Ig heavy chains connected to two Ig light chains. When the plasma cells become cancerous, it can result in an increase in monoclonal immunoglobulin in the blood serum. This is used as a measure of the tumor load. The information below gives which specific monoclonal immunoglobulin was detected.","paramType":"COUNT_OF_PARTICIPANTS","title":"Serum Heavy/Light Chain","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"18","upperLimit":"45","value":"28"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Body Mass Index (BMI)","unitOfMeasure":"Kg/m^2"}]}