{"preliminary_commentary":{"by_channel":{"x_thread":16,"podcast":2,"youtube":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01734928\", \"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."},"name":"OPTIMISMM","nct_id":"NCT01734928","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=optimismm-nct01734928. 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":"OPTIMISMM","arms":[{"description":"4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day \\[≤ 75 years old\\] or 10 mg/day \\[\\> 75 years old\\] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.","label":"Pomalidomide, Bortezomib and Low Dose Dexamethasone","type":"EXPERIMENTAL"},{"description":"1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day \\[≤ 75 years old\\]or 10 mg/day \\[\\> 75 years old\\] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.","label":"Bortezomib and Low Dose Dexamethasone","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2022-05-13","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":559,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Pomalidomide","otherNames":["Oral Pomalidomide","CC-4047"],"type":"DRUG"},{"name":"Bortezomib","otherNames":["Velcade"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2023-06-06","lead_sponsor":"Celgene","official_title":"A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-05-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival by Independent Response Adjudication Committee (IRAC)","timeFrame":"From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months"}],"references":[{"citation":"Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.","pmid":"31097405","type":"DERIVED"},{"citation":"Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2.","pmid":"28642620","type":"DERIVED"}],"start_date":{"date":"2013-01-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT01734928"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/optimismm-nct01734928"}