{"denoms":[{"counts":[{"groupId":"BG000","value":"18"}],"units":"Participants"}],"groups":[{"description":"Lenalidomide Induction (with Low Dose Dexamethasone) Therapy Followed by Low Dose Melphalan, Prednisone, Lenalidomide and Bortezomib Sequential Maintenance Therapy\n\nInduction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.\n\nMaintenance Therapy: Subjects who achieve \\>partial response (PR) after induction will receive repeating triplet 28-day cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \\> stable disease (SD) from maintenance:\n\n* 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis\n* Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8\n* Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7\n* Prednisone 60 mg /m2 po daily on Days 1-7\n* Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21.","id":"BG000","title":"High-risk Multiple Myeloma"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"12"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"10"}],"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":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"9"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"0"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"18"}],"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":"18"}]}],"title":"United States"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}],"populationDescription":"Subjects enrolled and able to initiate induction therapy."}