{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T15:56:21Z","timestamp":1765727781623,"version":"build-2065373602"},"reference-count":26,"publisher":"BMJ","issue":"1","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2014,12,9]]},"published-print":{"date-parts":[[2015,1]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Polyneuropathy, organomegaly, endocrinopathy, M-protein and skin changes (POEMS) syndrome is a fatal systemic disorder associated with plasma cell dyscrasia and the overproduction of the vascular endothelial growth factor (VEGF). Recently, the prognosis of POEMS was substantially improved by introduction of therapeutic intervention for myeloma. However, no randomised clinical trial has been performed because of the rarity and severity of the disease.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>The Japanese POEMS syndrome with Thalidomide (J-POST) Trial is a phase II\/III multicentre, double-blinded, randomised, controlled trial that aims to evaluate the efficacy and safety of a 24-week treatment with thalidomide in POEMS syndrome, with an additional 48-week open-label safety study. Adults with POEMS syndrome who have no indication for transplantation are assessed for eligibility at 12 tertiary neurology centres in Japan. Patients who satisfy the eligibility criteria are randomised (1:1) to receive thalidomide (100\u2013300\u2005mg daily) plus dexamethasone (12\u2005mg\/m<jats:sup>2<\/jats:sup> on days 1\u20134 of a 28-day cycle) or placebo plus dexamethasone. Both treatments were administered for 24\u2005weeks (six cycles; randomised comparative study period). Patients who complete the randomised study period or show subacute deterioration during the randomised period participate in the subsequent 48-week open-label safety study (long-term safety period). The primary end point of the study is the reduction rate of serum VEGF levels at 24\u2005weeks.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The protocol was approved by the Institutional Review Board of each hospital. The trial was notified and registered at the Pharmaceutical and Medical Devices Agency, Japan (No. 22-1716). The J-POST Trial is currently ongoing and is due to finish in August 2015. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations and will also be disseminated to participants.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>UMIN000004179 and JMA-IIA00046.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2014-007330","type":"journal-article","created":{"date-parts":[[2015,1,9]],"date-time":"2015-01-09T01:51:52Z","timestamp":1420768312000},"page":"e007330","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Japanese POEMS syndrome with Thalidomide (J-POST) Trial: study protocol for a phase II\/III multicentre, randomised, double-blind, placebo-controlled trial"],"prefix":"10.1136","volume":"5","author":[{"given":"Kanako","family":"Katayama","sequence":"first","affiliation":[{"name":"Clinical Research Center, Chiba University Hospital, Chiba, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sonoko","family":"Misawa","sequence":"additional","affiliation":[{"name":"Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasunori","family":"Sato","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Chiba University Hospital, Chiba, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gen","family":"Sobue","sequence":"additional","affiliation":[{"name":"Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ichiro","family":"Yabe","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hokkaido University Graduate School of Medicine, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Osamu","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Neurology and Geriatrics, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masatoyo","family":"Nishizawa","sequence":"additional","affiliation":[{"name":"Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susumu","family":"Kusunoki","sequence":"additional","affiliation":[{"name":"Department of Neurology, Faculty of Medicine, Kinki University, Osaka-Sayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seiji","family":"Kikuchi","sequence":"additional","affiliation":[{"name":"Department of Neurology, National Hospital Organization Hokkaido Medical Center, Sapporo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ichiro","family":"Nakashima","sequence":"additional","affiliation":[{"name":"Department of Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shu-ichi","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Medicine (Neurology and Rheumatology), Shinshu University School of Medicine, Matsumoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuo","family":"Kohara","sequence":"additional","affiliation":[{"name":"Department of Neurology, Kobe City Medical Center General Hospital, Kobe, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Kanda","sequence":"additional","affiliation":[{"name":"Department of Neurology and Clinical Neuroscience, Graduate School of Medicine Yamaguchi University, Ube, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun-ichi","family":"Kira","sequence":"additional","affiliation":[{"name":"Department of Neurology, Neurological Institute, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hideki","family":"Hanaoka","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Chiba University Hospital, Chiba, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Satoshi","family":"Kuwabara","sequence":"additional","affiliation":[{"name":"Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2015,1,8]]},"reference":[{"key":"2025101810251793000_5.1.e007330.1","doi-asserted-by":"crossref","first-page":"311","DOI":"10.1097\/00005792-198007000-00006","article-title":"Plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes: the POEMS syndrome. 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