{"preliminary_commentary":{"by_channel":{"youtube":1,"x_thread":1,"bluesky_thread":1},"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":null,"indication":null,"name":"iinnovate-1","nct_id":"NCT03215030","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=iinnovate-1-nct03215030. 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":"iinnovate-1","arms":[{"description":"Participants received Modakafusp alfa 0.001 up to 0.75 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation.","label":"Part 1 (Dose Escalation) Schedule A","type":"EXPERIMENTAL"},{"description":"Participants received Modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.","label":"Part 1 (Dose Escalation) Schedule B","type":"EXPERIMENTAL"},{"description":"Participants received Modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation.","label":"Part 1 (Dose Escalation) Schedule C","type":"EXPERIMENTAL"},{"description":"Participants received Modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","label":"Part 1 (Dose Escalation) Schedule D","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","label":"Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.","label":"Part 2 (Dose Expansion):ScheduleC:Modakafusp Alfa+Dexamethasone","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","label":"Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.","label":"Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.","label":"Part 3 (Dose Extension): Modakafusp Alfa 120 mg","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.","label":"Part 3 (Dose Extension): Modakafusp Alfa 240 mg","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.","label":"Japan Lead-in: Modakafusp Alfa 60 mg","type":"EXPERIMENTAL"},{"description":"Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.","label":"Japan Lead-in: Modakafusp Alfa 120 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-11-07","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":272,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Modakafusp alfa","otherNames":["TAK-573","TEV-48573"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2026-01-29","lead_sponsor":"Teva Branded Pharmaceutical Products R&D LLC","official_title":"A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma","overall_status":"TERMINATED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2024-07-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part 1: Percentage of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs)","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)","timeFrame":"Up to Cycle 1 (cycle length was 28 days for Schedule A, B and D; 21 days for Schedule C)"},{"measure":"Part 1: Percentage of Participants Reporting One or More Grade 3 or Higher TEAEs","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants Reporting One or More Serious Treatment-emergent Adverse Events (Serious TEAEs)","timeFrame":"Up to approximately 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants Who Discontinued the Treatment Because of TEAE","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Delay","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Interruptions","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants With TEAEs Resulting in Dose Modifications: Dose Reductions","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants With Clinically Significant Laboratory Values","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 1: Percentage of Participants With Clinically Significant Vital Signs Measurements","timeFrame":"Up to 54.3 months in Part 1"},{"measure":"Part 2: Overall Response Rate (ORR)","timeFrame":"Up to 34.7 months in Part 2"},{"measure":"Part 3: Overall Response Rate (ORR) Assessed by Independent Review Committee (IRC)","timeFrame":"Up to 20.5 months in Part 3"}],"references":[{"citation":"Holstein SA, Atrash S, Mian H, Dimopoulos MA, Schjesvold F, Popat R, Shah N, Gatt ME, Gocke CB, Frenzel L, Touzeau C, Beksac M, Manier S, Magen H, Travis P, Nadeem O, Suryanarayan K, Li C, Li S, Nelson A, Cherepanov D, Parot X, Vogl DT. A phase 2 randomized study of modakafusp alfa as a single agent for patients with relapsed/refractory multiple myeloma. Blood. 2025 Aug 28;146(9):1051-1064. doi: 10.1182/blood.2024027873.","pmid":"40279508","type":"DERIVED"},{"citation":"Vogl DT, Atrash S, Holstein SA, Nadeem O, Benson D, Chaudry M, Biran N, Suryanarayan K, Li C, Liu Y, Collins S, Parot X, Kaufman JL. Targeted interferon therapy with modakafusp alfa for relapsed or refractory multiple myeloma. Blood. 2025 Feb 27;145(9):944-955. doi: 10.1182/blood.2024026124.","pmid":"39630057","type":"DERIVED"}],"start_date":{"date":"2017-10-04","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT03215030"},"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/iinnovate-1-nct03215030"}