{"preliminary_commentary":{"by_channel":{"x_thread":2,"podcast":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","cyclophosphamide","dexamethasone"]],"indication":"newly diagnosed or relapsed/refractory multiple myeloma","name":"C16020","nct_id":"NCT02046070","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=c16020-nct02046070. 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 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until progressive disease (PD)/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","label":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (NDMM)","type":"EXPERIMENTAL"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle until PD/death or unacceptable toxicity \\[13 cycles in the Induction Phase continuing in the Maintenance Phase for up to 36 Months\\] and cyclophosphamide (CYC) 400 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle for 13 cycles or until PD/death or unacceptable toxicity in participants with NDMM.","label":"Ixazomib 4.0 mg + CYC 400 mg/m^2 + DEX 40 mg (NDMM)","type":"EXPERIMENTAL"},{"description":"Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 15 of a 28-day cycle and cyclophosphamide 300 mg/m\\^2, tablets, orally, on Days 1, 8 and 15 of a 28-day cycle and dexamethasone (DEX) 40 mg, tablets, orally, on Days 1, 8, 15 and 22 (dose reduced to 20 mg for patients \\>75 years) of a 28-day cycle until PD/death or unacceptable toxicity in participants with RRMM.","label":"Ixazomib 4.0 mg + CYC 300 mg/m^2 + DEX 40 mg (RRMM)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2018-06-29","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":148,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Ixazomib","otherNames":["MLN9708"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2019-07-17","lead_sponsor":"Millennium Pharmaceuticals, Inc.","official_title":"An Open-Label, Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma Requiring Systemic Treatment","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2018-06-29","type":"ACTUAL"},"primary_outcomes":[{"measure":"Combined Response Rate During the Induction Phase in Newly Diagnosed Multiple Myeloma (NDMM) Participants","timeFrame":"Day 1 of Cycles 1-13, 28-day cycles (Up to 1 year)"},{"measure":"Overall Response Rate (ORR) in Relapsed and/or Refractory Multiple Myeloma (RRMM) Participants","timeFrame":"Day 1 of each 28 day cycle (Up to 45 months)"}],"references":[{"citation":"Dimopoulos MA, Grosicki S, Jedrzejczak WW, Nahi H, Gruber A, Hansson M, Gupta N, Byrne C, Labotka R, Teng Z, Yang H, Grzasko N, Kumar S. All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Eur J Cancer. 2019 Jan;106:89-98. doi: 10.1016/j.ejca.2018.09.011. Epub 2018 Nov 22.","pmid":"30471652","type":"DERIVED"},{"citation":"Kumar SK, Grzasko N, Delimpasi S, Jedrzejczak WW, Grosicki S, Kyrtsonis MC, Spencer A, Gupta N, Teng Z, Byrne C, Labotka R, Dimopoulos MA. Phase 2 study of all-oral ixazomib, cyclophosphamide and low-dose dexamethasone for relapsed/refractory multiple myeloma. Br J Haematol. 2019 Feb;184(4):536-546. doi: 10.1111/bjh.15679. Epub 2018 Nov 20.","pmid":"30460684","type":"DERIVED"}],"start_date":{"date":"2014-03-05","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT02046070"},"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/c16020-nct02046070"}