{"preliminary_commentary":{"by_channel":{"x_thread":3},"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,"drugs_tested":[["venetoclax","daratumumab","dexamethasone"],["venetoclax","daratumumab","dexamethasone","bortezomib"]],"indication":"relapsed or refractory multiple myeloma","name":"NCT03314181","nct_id":"NCT03314181","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03314181. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Venetoclax (Ven) various doses administered orally, once daily (QD) in combination with daratumumab (D) (1800 mg subcutaneous injection (preferred) or 16 mg/kg intravenous \\[IV\\]) administered in accordance with prescribing information and dexamethasone (d) (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).","label":"Arm A, Part 1a: VenDd Dose Escalation","type":"EXPERIMENTAL"},{"description":"Venetoclax at a dose determined by the dose-escalation phase, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).","label":"Arm B, Part 1b: VenDd Dose Expansion","type":"EXPERIMENTAL"},{"description":"Venetoclax at various doses administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection \\[preferred\\] or IV) Cycles 1-8, Days 1, 4, 8 and 11), and dexamethasone (oral or IV) 20 mg Cycles 1 - 3, Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 20 mg Cycles 4-8, Days 1,2,4,5,8,9,11 and 12; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) Cycle 9+.","label":"Arm D, Part 2a: VenDVd Dose Escalation","type":"EXPERIMENTAL"},{"description":"Venetoclax at dose determined by the dose-escalation phase, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection) Cycles 1-8, Days 1, 4, 8 and 11, and dexamethasone (oral or IV) 20 mg Cycles 1 - 3, Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 20 mg Cycles 4-8, Days 1,2,4,5,8,9,11 and 12; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) Cycle 9+.","label":"Arm E, Part 2b: VenDVd Dose Expansion","type":"EXPERIMENTAL"},{"description":"Venetoclax at a pre-determined dose, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).","label":"Arm F: VenDd Dose Expansion","type":"EXPERIMENTAL"},{"description":"Venetoclax at a pre-determined dose, administered orally QD in combination with daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information and dexamethasone (oral or IV) 40 mg weekly (or 20 mg weekly, if necessary, as described in the protocol).","label":"Arm G: VenDd Dose Expansion","type":"EXPERIMENTAL"},{"description":"Daratumumab (1800 mg subcutaneous injection (preferred) or 16 mg/kg IV) administered in accordance with prescribing information, bortezomib (1.3 mg/m2 subcutaneous injection) Cycles 1-8: Days 1, 4, 8 and 11, and dexamethasone (oral or IV) 20 mg on Cycles 1 - 3: Days 1, 2, 4, 5, 8, 9, 11,12 and 15; 40 mg weekly (or 20 mg weekly, if necessary as described in the protocol) on Cycles 4-8: Days 1,2,4,5,8,9,11 and 12; 20 mg monthly for Cycles 9+: Day 1","label":"Arm H: DVd Dose","type":"ACTIVE_COMPARATOR"}],"collaborators":["Janssen Research & Development, LLC"],"completion_date":{"date":"2031-05","type":"ESTIMATED"},"conditions":["Multiple Myeloma"],"enrollment":{"count":156,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Daratumumab","otherNames":[],"type":"DRUG"},{"name":"Venetoclax","otherNames":["ABT-199","Venclexta"],"type":"DRUG"},{"name":"Bortezomib","otherNames":[],"type":"DRUG"}],"last_update":"2025-08-14","lead_sponsor":"AbbVie","official_title":"A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects With Relapsed or Refractory Multiple Myeloma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2031-05","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Response Rate (ORR)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Very Good Partial Response or Better Response Rate (VGPR)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Complete Response (CR) or Better Rate","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Time to Response (TTR)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Duration of Response (DOR)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Time to Progression (TTP)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Progression-Free Survival (PFS)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"},{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 3.5 years after the last participant is enrolled"}],"references":[{"citation":"Bahlis NJ, Baz R, Harrison SJ, Quach H, Ho SJ, Vangsted AJ, Plesner T, Moreau P, Gibbs SD, Coppola S, Yang X, Al Masud A, Ross JA, Bueno O, Kaufman JL. Phase I Study of Venetoclax Plus Daratumumab and Dexamethasone, With or Without Bortezomib, in Patients With Relapsed or Refractory Multiple Myeloma With and Without t(11;14). J Clin Oncol. 2021 Nov 10;39(32):3602-3612. doi: 10.1200/JCO.21.00443. Epub 2021 Aug 13.","pmid":"34388020","type":"DERIVED"}],"start_date":{"date":"2018-04-02","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03314181"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03314181"}