{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T06:49:06Z","timestamp":1793774946586,"version":"4.6.1"},"reference-count":28,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,4,6]],"date-time":"2017-04-06T00:00:00Z","timestamp":1491436800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2017,7]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>This phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study explored the effects of bortezomib consolidation <jats:italic>versus<\/jats:italic> observation on myeloma\u2010related bone disease in patients who had a partial response or better after frontline high\u2010dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35\u2010day cycles of bortezomib 1\u00b76\u00a0mg\/m<jats:sup>2<\/jats:sup> intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status\/survival. The modified intent\u2010to\u2010treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (<jats:styled-content style=\"fixed-case\">BMD<\/jats:styled-content>). End\u2010of\u2010treatment rates (bortezomib <jats:italic>versus<\/jats:italic> observation) of complete response\/stringent complete response were 22% vs. 11% (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0\u00b719), very good partial response or better of 80% vs. 68% (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0\u00b717), and progressive disease of 8% vs. 23% (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0\u00b706); median progression\u2010free survival was 44\u00b79\u00a0months vs. 21\u00b78\u00a0months (<jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0\u00b722). Adverse events observed \u226515% more frequently with bortezomib <jats:italic>versus<\/jats:italic> observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism\/health, but was associated with trends for improved myeloma response and survival.<\/jats:p>","DOI":"10.1111\/bjh.14637","type":"journal-article","created":{"date-parts":[[2017,4,6]],"date-time":"2017-04-06T07:19:25Z","timestamp":1491463165000},"page":"61-71","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Effects of single\u2010agent bortezomib as post\u2010transplant consolidation therapy on multiple myeloma\u2010related bone disease: a randomized phase <scp>II<\/scp> study"],"prefix":"10.1111","volume":"178","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8645-9573","authenticated-orcid":false,"given":"Orhan","family":"Sezer","sequence":"first","affiliation":[{"name":"Department of Haematology, Oncology, and Bone Marrow Transplantation Universitaetsklinikum Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meral","family":"Beksac","sequence":"additional","affiliation":[{"name":"Department of Medicine Ankara University Ankara Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roman","family":"Hajek","sequence":"additional","affiliation":[{"name":"Department of Haemato\u2010oncology University Hospital Ostrava Ostrava Czech Republic"},{"name":"Faculty of Medicine University Ostrava Ostrava Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G\u00fclsan","family":"Sucak","sequence":"additional","affiliation":[{"name":"Department of Haematology Faculty of Medicine Gazi University Ankara Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seckin","family":"Cagirgan","sequence":"additional","affiliation":[{"name":"Department of Haematology Izmir Medical Park Private Hospital Izmir Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Werner","family":"Linkesch","sequence":"additional","affiliation":[{"name":"Department of Haematology Medical University Clinic Medical University of Graz Graz Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Meltem Akay","sequence":"additional","affiliation":[{"name":"Department of Haematology Eskisehir Osmangazi University Eskisehir Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zafer","family":"G\u00fclbas","sequence":"additional","affiliation":[{"name":"Department of Haematology Eskisehir Osmangazi University Eskisehir Turkey"},{"name":"Oncologic Sciences Anadolu Health Centre Kocaeli Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hareth","family":"Nahi","sequence":"additional","affiliation":[{"name":"Department of Haematology Karolinska University Hospital Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torben","family":"Plesner","sequence":"additional","affiliation":[{"name":"Department of Haematology Vejle Hospital Vejle Denmark"},{"name":"IRS\/University of Southern Denmark Vejle Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John A.","family":"Snowden","sequence":"additional","affiliation":[{"name":"Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK"},{"name":"Department of Oncology and Metabolism University of Sheffield Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ay\u015fen","family":"Timura\u011fao\u011flu","sequence":"additional","affiliation":[{"name":"Department of Haematology Akdeniz University Antalya Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"Dechow","sequence":"additional","affiliation":[{"name":"III. Medical Dept., Klinikum Rechts der Isar Technical University Munich Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alois","family":"Lang","sequence":"additional","affiliation":[{"name":"Department of Haematology and Oncology LandesKrankenhaus Feldkirch Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T\u00fclin","family":"Tu\u011flular","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Marmara University Istanbul Turkey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Drach","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I Division of Oncology Medical University of Vienna Vienna General Hospital Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Armbrecht","sequence":"additional","affiliation":[{"name":"Department of Radiology Centre for Muscle and Bone Research Charit\u00e9 \u2013 Campus Benjamin Franklin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Potamianou","sequence":"additional","affiliation":[{"name":"Janssen\u2010Cilag Pharmaceutical SACI Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Couturier","sequence":"additional","affiliation":[{"name":"Janssen\u2010Cilag Issy\u2010les\u2010Moulineaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Olie","sequence":"additional","affiliation":[{"name":"Janssen\u2010Cilag AG Zug Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Feys","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development Division of Janssen Pharmaceutica NV Beerse Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Allietta","sequence":"additional","affiliation":[{"name":"Janssen\u2010Cilag Issy\u2010les\u2010Moulineaux France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos","family":"Terpos","sequence":"additional","affiliation":[{"name":"Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine Alexandra General Hospital Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,4,6]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2012-02-408898"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-08-4472"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0609.2011.01599.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1097\/SPC.0000000000000090"},{"key":"e_1_2_8_6_1","volume-title":"VELCADE\u00ae (Bortezomib). 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