{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"name":"EAA172","nct_id":"NCT03701321","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=eaa172-nct03701321. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive daratumumab IV on days 1, 8, and 15 of cycles 1-3 and on day 1 of subsequent cycles, bortezomib SC on days 1, 8, and 15 of cycles 1-8, dexamethasone PO on days 1, 8, and 15 of cycles 1-8, and venetoclax PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.","label":"Phase I (DVd, venetoclax)","type":"EXPERIMENTAL"},{"description":"Patients receive venetoclax PO QD on days 1-21, daratumumab IV on days 1, 8, and 15 of cycles 1-3 and on day 1 of subsequent cycles, bortezomib SC on days 1, 8, and 15 of cycles 1-8, and dexamethasone PO on days 1, 8, and 15 of cycles 1-8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.","label":"Phase II Arm D (DVd, venetoclax)","type":"EXPERIMENTAL"},{"description":"Patients receive daratumumab IV on days 1, 8, and 15 of cycles 1-3 and on day 1 of subsequent cycles, bortezomib SC on days 1, 8, and 15 of cycles 1-8, and dexamethasone PO on days 1, 8, and 15 of cycles 1-8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.","label":"Phase II Arm E (DVd)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2020-05-28","type":"ESTIMATED"},"conditions":["Recurrent Plasma Cell Myeloma","Refractory Plasma Cell Myeloma"],"enrollment":{"count":0,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Bortezomib","otherNames":["[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid","LDP 341","MLN341","PS-341","PS341","Velcade"],"type":"DRUG"},{"name":"Daratumumab","otherNames":["Anti-CD38 Monoclonal Antibody","Darzalex","HuMax-CD38","JNJ-54767414"],"type":"BIOLOGICAL"},{"name":"Dexamethasone","otherNames":["Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Fluorodelta","Fortecortin","Gammacorten","Hexadecadrol","Hexadrol","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex"],"type":"DRUG"},{"name":"Venetoclax","otherNames":["ABT-0199","ABT-199","ABT199","GDC-0199","RG7601","Venclexta","Venclyxto"],"type":"DRUG"}],"last_update":"2023-09-26","lead_sponsor":"National Cancer Institute (NCI)","official_title":"Phase 1/2 Study of Daratumumab, Bortezomib, Dexamethasone With or Without Venetoclax in Relapsed/Refractory Multiple Myeloma With Assessment for t(11;14) Status","overall_status":"WITHDRAWN","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2020-05-28","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Maximum tolerated dose of venetoclax in combination with daratumumab, bortezomib and dexamethasone (Phase I)","timeFrame":"Up to 35 days"},{"measure":"Minimal residual disease (MRD) negative status (Phase II)","timeFrame":"After cycle 8"}],"references":[],"start_date":{"date":"2019-01-25","type":"ESTIMATED"},"study_type":"INTERVENTIONAL","title":"Daratumumab, Bortezomib, and Dexamethasone With or Without Venetoclax in Treating Patients With Relapsed or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03701321"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/eaa172-nct03701321"}