{"commentary":{"count":22,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":13,"youtube":9},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01208766\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"HO95","nct_id":"NCT01208766","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ho95-nct01208766. The price is fixed at order. We build the report after 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: 13–40 commentary sources"},"registry":{"acronym":"HO95","arms":[{"description":"All patients randomized to VMP treatment, will be treated with Bortezomib, Melphalan, Prednisone(VMP, 4 cycles) and will start intensification with VMP between 4 and 6 weeks after stem cell collection.","label":"R1: 4 cycles Bortezomib, Melphalan, Prednisone (VMP)","type":"ACTIVE_COMPARATOR"},{"description":"All patients randomized to intensification with High Dose Melphalan will start intensification with HDM (in hospitals with a policy of double intensification, patients will be randomized between VMP, 1 HDM and 2 HDM) between 4 and 6 weeks after stem cell collection.","label":"R1: 1 (2) cycle(s) HDM","type":"EXPERIMENTAL"},{"description":"No consolidation, patients will continue to Lenalidomide maintenance.","label":"R2: none","type":"NO_INTERVENTION"},{"description":"In patients randomized to consolidation treatment, 2 cycles of Bortezomib, Lenalidomide,Dexamethasone (VRD) will start at 8 weeks after the end of the last course of VMP or HDM.","label":"R2: 2 cycles of VRD","type":"EXPERIMENTAL"}],"collaborators":["European Myeloma Network B.V.","Gruppo Italiano Malattie EMatologiche dell'Adulto","DSMM (Deutsche Studiengruppe Multiples Myelom)","NMSG (Nordic Myeloma Study Group)","Central European Myeloma Study Group"],"completion_date":{"date":"2025-01","type":"ACTUAL"},"conditions":["Multiple Myeloma"],"enrollment":{"count":1503,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Bortezomib, Melphalan, Prednisone (VMP)","type":"DRUG"},{"name":"1 or 2 cycle(s) HDM (High Dose Melphalan)","type":"DRUG"},{"name":"2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)","type":"DRUG"}],"last_update":"2026-01-06","lead_sponsor":"Stichting Hemato-Oncologie voor Volwassenen Nederland","official_title":"A Randomized Phase III Study to Compare Bortezomib, Melphalan, Prednisone (VMP) With High Dose Melphalan Followed by Bortezomib, Lenalidomide, Dexamethasone (VRD) Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2020-12","type":"ACTUAL"},"primary_outcomes":[{"measure":"For all registered patients: progression free survival (PFS) as defined by time from registration to progression or death from any cause (whichever occurs first).","timeFrame":"end of trial (last patient last visit)"},{"measure":"For all patients included in R1; PFS as defined by time from randomization R1 to progression or death from any cause whichever comes first","timeFrame":"end of trial (last patient last visit)"},{"measure":"For all patients included in R2; PFS as defined by time from randomization R2 to progression or death from any cause whichever comes first","timeFrame":"end of trial (last patient last visit)"}],"references":[{"citation":"Mai EK, Hielscher T, Bertsch U, Salwender HJ, Zweegman S, Raab MS, Munder M, Pantani L, Mancuso K, Brossart P, Beksac M, Blau IW, Durig J, Besemer B, Fenk R, Reimer P, van der Holt B, Hanel M, von Metzler I, Graeven U, Muller-Tidow C, Boccadoro M, Scheid C, Dimopoulos MA, Hillengass J, Weisel KC, Cavo M, Sonneveld P, Goldschmidt H. Predictors of early morbidity and mortality in newly diagnosed multiple myeloma: data from five randomized, controlled, phase III trials in 3700 patients. Leukemia. 2024 Mar;38(3):640-647. doi: 10.1038/s41375-023-02105-6. Epub 2023 Dec 7.","pmid":"38062124","type":"DERIVED"},{"citation":"Schmitz A, Brondum RF, Johnsen HE, Mellqvist UH, Waage A, Gimsing P, Op Bruinink DH, van der Velden V, van der Holt B, Hansson M, Andersen NF, Frolund UC, Helleberg C, Schjesvold FH, Ahlberg L, Gulbrandsen N, Andreasson B, Lauri B, Haukas E, Bodker JS, Roug AS, Bogsted M, Severinsen MT, Gregersen H, Abildgaard N, Sonneveld P, Dybkaer K. Longitudinal minimal residual disease assessment in multiple myeloma patients in complete remission - results from the NMSG flow-MRD substudy within the EMN02/HO95 MM trial. BMC Cancer. 2022 Feb 5;22(1):147. doi: 10.1186/s12885-022-09184-1.","pmid":"35123422","type":"DERIVED"},{"citation":"Sonneveld P, Dimopoulos MA, Beksac M, van der Holt B, Aquino S, Ludwig H, Zweegman S, Zander T, Zamagni E, Wester R, Hajek R, Pantani L, Dozza L, Gay F, Cafro A, De Rosa L, Morelli A, Gregersen H, Gulbrandsen N, Cornelisse P, Troia R, Oliva S, van de Velden V, Wu K, Ypma PF, Bos G, Levin MD, Pour L, Driessen C, Broijl A, Croockewit A, Minnema MC, Waage A, Hveding C, van de Donk NWCJ, Offidani M, Palumbo GA, Spencer A, Boccadoro M, Cavo M. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma. J Clin Oncol. 2021 Nov 10;39(32):3613-3622. doi: 10.1200/JCO.21.01045. Epub 2021 Sep 14.","pmid":"34520219","type":"DERIVED"},{"citation":"Cavo M, Gay F, Beksac M, Pantani L, Petrucci MT, Dimopoulos MA, Dozza L, van der Holt B, Zweegman S, Oliva S, van der Velden VHJ, Zamagni E, Palumbo GA, Patriarca F, Montefusco V, Galli M, Maisnar V, Gamberi B, Hansson M, Belotti A, Pour L, Ypma P, Grasso M, Croockewit A, Ballanti S, Offidani M, Vincelli ID, Zambello R, Liberati AM, Andersen NF, Broijl A, Troia R, Pascarella A, Benevolo G, Levin MD, Bos G, Ludwig H, Aquino S, Morelli AM, Wu KL, Boersma R, Hajek R, Durian M, von dem Borne PA, Caravita di Toritto T, Zander T, Driessen C, Specchia G, Waage A, Gimsing P, Mellqvist UH, van Marwijk Kooy M, Minnema M, Mandigers C, Cafro AM, Palmas A, Carvalho S, Spencer A, Boccadoro M, Sonneveld P. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study. Lancet Haematol. 2020 Jun;7(6):e456-e468. doi: 10.1016/S2352-3026(20)30099-5. Epub 2020 Apr 30.","pmid":"32359506","type":"DERIVED"},{"citation":"Gambella M, Omede P, Spada S, Muccio VE, Gilestro M, Saraci E, Grammatico S, Larocca A, Conticello C, Bernardini A, Gamberi B, Troia R, Liberati AM, Offidani M, Rocci A, Palumbo A, Cavo M, Sonneveld P, Boccadoro M, Oliva S. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis. Cancer. 2019 Mar 1;125(5):750-760. doi: 10.1002/cncr.31854. Epub 2018 Dec 18.","pmid":"30561775","type":"DERIVED"}],"start_date":{"date":"2011-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study to Compare VMP With HDM Followed by VRD Consolidation and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma","url":"https://clinicaltrials.gov/study/NCT01208766"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/ho95-nct01208766"}