{"preliminary_commentary":{"by_channel":{"youtube":3,"x_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":[["ixazomib","lenalidomide","dexamethasone"]],"indication":"newly diagnosed multiple myeloma","name":"C16008","nct_id":"NCT01383928","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=c16008-nct01383928. 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":"Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed, in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.","label":"Phase 1: Ixazomib 3 mg or 3.7 mg","type":"EXPERIMENTAL"},{"description":"Ixazomib (MLN9708), orally, twice-weekly in combination with lenalidomide orally and dexamethasone orally as prescribed, in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) orally, twice weekly in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.","label":"Phase 2: Ixazomib 3 mg","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2017-11-27","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":64,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Ixazomib","otherNames":[],"type":"DRUG"},{"name":"Lenalidomide","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2019-03-21","lead_sponsor":"Millennium Pharmaceuticals, Inc.","official_title":"An Open-Label, Dose-Escalation, Phase 1/2 Study of the Oral Formulation of IXAZOMIB (MLN9708), Administered Twice-weekly in Combination With Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Requiring Systemic Treatment","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2014-10-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase 1: Maximum Tolerated Dose (MTD)","timeFrame":"Cycle 1 (21 days)"},{"measure":"Phase 1: Recommended Phase 2 Dose (RP2D)","timeFrame":"Cycle 1 (21 days)"},{"measure":"Phase 1: Percentage of Participants Experiencing 1 or More Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)","timeFrame":"Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)"},{"measure":"Phase 1: Number of Participants With Markedly Abnormal Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)","timeFrame":"Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)"},{"measure":"Phase 1: Number of Participants With Treatment-Emergent Adverse Events (TEAE) Related to Neurotoxicity","timeFrame":"Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)"},{"measure":"Phase 1: Number of Participants With Clinically Significant Change From Baseline in Vital Signs","timeFrame":"Baseline up to 30 days after last dose of study drug (Up to Cycle 83 - approximately 2067 days)"},{"measure":"Phase 2: Percentage of Participants With Complete Response (CR) + Very Good Partial Response (VGPR)","timeFrame":"Baseline until end of treatment (Up to treatment Cycle 74 - approximately 1875 days)"},{"measure":"Phase 2: Percentage of Participants With Grade 3 or Higher Adverse Events","timeFrame":"Baseline up to 30 days after the last dose of study drug (approximately 1905 days)"},{"measure":"Phase 2: Percentage of Participants Experiencing Serious Adverse Events","timeFrame":"Baseline up to 30 days after the last dose of study drug (approximately 1905 days)"},{"measure":"Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events Resulting in Study Drug Discontinuation","timeFrame":"Baseline up to 30 days after the last dose of study drug (approximately 1905 days)"}],"references":[],"start_date":{"date":"2011-10-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT01383928"},"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/c16008-nct01383928"}