{"denoms":[{"counts":[{"groupId":"BG000","value":"40"}],"units":"Participants"}],"groups":[{"description":"Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles.\n\n* Elotuzumab will be administered by intravenous (IV) infusion\n* Bortezomib as a subcutaneous injection\n* Lenalidomide single daily oral dose\n* Dexamethasone as oral tablets and IV infusion\n* Stem cell mobilization will be performed for all subjects at the end of Cycle 4.\n\nSubjects may elect to stop E-RVD at the end of Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy.\n\nThe maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it.\n\nMaintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category.","id":"BG000","title":"Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"24"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"16"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"8.6","value":"61"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17"}],"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":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"28"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"5"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"26"}],"title":"Grade 0"},{"measurements":[{"groupId":"BG000","value":"13"}],"title":"Grade 1"},{"measurements":[{"groupId":"BG000","value":"1"}],"title":"Grade 2"}]}],"description":"Eastern Cooperative Oncology Group (ECOG) Performance Status: (PS0) Fully active, able to carry on all pre-disease performance without restriction (PS1) Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (PS2) Ambulatory and capable of all self-care but unable to carry out any work activities; Up and about \\>50% of waking hours. Higher grades indicate more severe disease.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"24"}],"title":"Stage I"},{"measurements":[{"groupId":"BG000","value":"10"}],"title":"Stage II"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Stage III"}]}],"description":"The International Staging System (ISS) consists of three stages: stage I, serum beta 2-microglobulin level lower than 3.5 mg per liter and serum albumin level 3.5 g per deciliter or higher; stage II, neither stage I nor III; and stage III, serum beta 2-microglobulin level 5.5 mg per liter or higher. Higher stages indicate more severe disease.","paramType":"COUNT_OF_PARTICIPANTS","title":"International Staging System (ISS) Multiple Myeloma Stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"6"}],"title":"High"},{"measurements":[{"groupId":"BG000","value":"19"}],"title":"Standard"},{"measurements":[{"groupId":"BG000","value":"15"}],"title":"Missing"}]}],"description":"Bone marrow aspiration and biopsy to be evaluated for cytogenetics by standard banding and FISH, including marrow karyotyping if possible. High-risk cytogenetics include presence of translocations t(4;14), t(14;16) or del17p.","paramType":"COUNT_OF_PARTICIPANTS","title":"Cytogenetic risk classification","unitOfMeasure":"Participants"}],"populationDescription":"The analysis population is safety- all treated participants."}