{"groups":[{"description":"* Induction regimen with Dara-Rd in all study subjects, weeks 1-24\n* Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36\n* Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88\n* Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).\n\nConsolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab.\n\nInduction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly","id":"FG000","title":"Dara-Rd Followed by Dara-RVd"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"56"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"46"}],"comment":"Participants that are positive move on to consolidation","type":"MRD +"},{"achievements":[{"groupId":"FG000","numSubjects":"5"}],"comment":"Participants that are negative move on to maintenance","type":"MRD -"},{"achievements":[{"groupId":"FG000","numSubjects":"51"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"5"}],"type":"NOT COMPLETED"}],"title":"Induction"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"off tx after MRD2, patient chose to go to ASCT off protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Subject moved out of state"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Alternative Therapy"}],"milestones":[{"achievements":[{"comment":"MRD- subjects move directly to Maintenance","groupId":"FG000","numSubjects":"46"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"}],"type":"MRD2+ and Received ACST"},{"achievements":[{"groupId":"FG000","numSubjects":"28"}],"type":"MRD2+ But no ACST"},{"achievements":[{"groupId":"FG000","numSubjects":"11"}],"type":"MRD-"},{"achievements":[{"groupId":"FG000","numSubjects":"43"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"3"}],"type":"NOT COMPLETED"}],"title":"Consolidation"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Noncompliance"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Other complicating conditions"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Continue to hold myeloma therapy given high-copay"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"discontinuation of health insurance"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Moving to transplant"}],"milestones":[{"achievements":[{"comment":"1 subject completed Induction but did not progress to Consolidation due to disease progression. 2 subjects started Consolidation but did not progress to Maintenance due to disease progression. 1 subject completed Consolidation and moved to Maintenance due to lack of support network required for ASCT procedure, then came off treatment for ASCT as primary therapy.","groupId":"FG000","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"30"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"14"}],"type":"NOT COMPLETED"}],"title":"Maintenance"}],"preAssignmentDetails":"1 subject enrolled, but did not start treatment due to physician discretion.","recruitmentDetails":"15 patients are still active in the Maintenance cohort. Completion data will be updated once all patients have completed treatment"}