{"preliminary_commentary":{"by_channel":{"x_thread":11,"youtube":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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03544281\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["belantamab mafodotin","lenalidomide","dexamethasone"],["belantamab mafodotin","bortezomib","dexamethasone"]],"indication":"relapsed/refractory multiple myeloma","name":"DREAMM 6","nct_id":"NCT03544281","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=dreamm-6-nct03544281. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"DREAMM 6","arms":[{"description":"Participants will receive SINGLE full dose of belantamab mafodotin as 2.5 mg/kg and 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 min infusion.\n\nSPLIT: belantamab mafodotin will be administered in two equal divided doses, 2.5 mg/kg SPLIT dose of a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle.\n\nSTRETCH: belantamab mafodotin will be administered as 1.9 mg/kg dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on.) Participants will also receive Lenalidomide 25 mg or 10 mg orally daily, on Days 1-21 of each 28 day cycle with Dexamethasone, 40 mg weekly per oral (PO)/intravenously (IV) on Days 1,8,15, \\& 22 of each cycle.","label":"Arm A: Belantamab mafodotin+lenalidomide +dexamethasone","type":"EXPERIMENTAL"},{"description":"Participants will receive SINGLE full dose of belantamab mafodotin as 3.4 mg/kg; 2.5 mg/kg; 1.9 mg/kg on Day 1 of each 21-day cycle. SPLIT: belantamab mafodotin will be administered in two equal divided doses: 3.4 mg/kg SPLIT as 1.7 mg/kg dose on Day 1 \\& 1.7 mg/kg dose on Day 8; 2.5 mg/kg SPLIT dosing as 1.25 mg/kg dose on Day 1 \\& 1.25 mg/kg dose on Day 8 of each 21-day cycle. STRETCH: belantamab mafodotin will be administered as single dose of 2.5 mg/kg on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 \\& so on), 1.9 mg/kg administered on Day 1 of every alternate 21-day cycles (C1,C3,C5,C7 and so on). Step Down(S/D) STRETCH=belantamab mafodotin 2.5 mg/kg dose will be administered on Day 1 C1 followed by 1.9 mg/kg starting dose on Day1 of alternate 21-day cycles C3 onwards (C3,C5,C7, \\& so on). Bortezomib will be administered at 1.3 mg/m\\^2 SC/IV on Days 1,4,8, \\& 11 of every 21-day cycle. Dex will be administered at 20 mg PO or IV on Days 1,2,4,5,8,9,11, \\& 12 of every 21-day cycle.","label":"Arm B: Belantamab mafodotin+bortezomib+dexamethasone","type":"EXPERIMENTAL"}],"collaborators":["IQVIA Pty Ltd"],"completion_date":{"date":"2024-02-28","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":153,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Belantamab mafodotin","otherNames":[],"type":"DRUG"},{"name":"Lenalidomide","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Bortezomib","otherNames":[],"type":"DRUG"}],"last_update":"2025-03-18","lead_sponsor":"GlaxoSmithKline","official_title":"A Phase I/II, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed / Refractory Multiple Myeloma - DREAMM-6","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2023-02-28","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Dose Limiting Toxicities (DLTs), Treatment A","timeFrame":"Up to 28 days"},{"measure":"Number of Participants With DLTs, Treatment B","timeFrame":"Up to 21 days"},{"measure":"Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","timeFrame":"Up to approximately 4.5 years"},{"measure":"Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)","timeFrame":"Up to approximately 4.5 years"},{"measure":"Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Number of Participants With Worst-case Change Post-baseline in Hematology Parameters","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Number of Participants With Worst-case Change Post Baseline Urinalysis Results: Occult Blood and Protein","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Change From Baseline in Urine Potential of Hydrogen (pH)","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Change From Baseline in Urine Specific Gravity","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Change From Baseline in Vital Signs : Pulse Rate","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Change From Baseline in Vital Signs : Temperature","timeFrame":"Baseline (Day 1) and up to approximately 4.5 years"},{"measure":"Overall Response Rate (ORR) as Defined by the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma (MM)","timeFrame":"Up to approximately 4.5 years"}],"references":[],"start_date":{"date":"2018-09-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)","url":"https://clinicaltrials.gov/study/NCT03544281"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/dreamm-6-nct03544281"}