{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T16:10:41Z","timestamp":1764259841619},"reference-count":21,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2013,5,27]],"date-time":"2013-05-27T00:00:00Z","timestamp":1369612800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2013,7]]},"abstract":"<jats:p>This phase I\/II study was conducted to evaluate the safety and efficacy of bortezomib\u2010melphalan\u2010prednisolone in Japanese patients with previously untreated multiple myeloma who are ineligible for hematopoietic stem cell transplantation. One hundred and one patients were enrolled, and 99 patients received up to nine 6\u2010week cycles of bortezomib (0.7\/1.0\/1.3\u00a0mg\/m<jats:sup>2<\/jats:sup>) on days 1, 4, 8, 11, 22, 25, 29, and 32 in cycles 1\u20134 and on days 1, 8, 22, and 29 in cycles 5\u20139, with melphalan (9\u00a0mg\/m<jats:sup>2<\/jats:sup>) and prednisolone (60\u00a0mg\/m<jats:sup>2<\/jats:sup>) on days 1\u20134 of each cycle. The recommended dose was determined in the phase I portion, and the overall response rate and safety of bortezomib\u2010melphalan\u2010prednisolone at the recommended dose were assessed in the phase II portion. The recommended dose of bortezomib was determined to be 1.3\u00a0mg\/m<jats:sup>2<\/jats:sup>. Grade 3 or higher non\u2010hematological adverse events included diarrhea (12%) and peripheral neuropathy (10%); grade 4 hematological adverse events included lymphopenia (41%), neutropenia (30%), and thrombocytopenia (22%). Eleven patients had lung injury associated with bortezomib; two had grade 3 disease, and the other nine had grade 1 or 2 disease. Of the 86 patients treated with 1.3\u2010mg\/m<jats:sup>2<\/jats:sup> bortezomib in phases I and II, the median number of treatment cycles was 4.5, and the overall response rate was 70% (95% confidence interval: 59\u201379%). Bortezomib\u2010melphalan\u2010prednisolone with 1.3\u2010mg\/m<jats:sup>2<\/jats:sup> bortezomib was considered to be tolerable and effective in Japanese patients with previously untreated multiple myeloma. However, further investigation is needed to refine the administration schedule.<\/jats:p>","DOI":"10.1111\/cas.12172","type":"journal-article","created":{"date-parts":[[2013,4,11]],"date-time":"2013-04-11T04:52:40Z","timestamp":1365655960000},"page":"912-919","source":"Crossref","is-referenced-by-count":17,"title":["Phase <scp>I<\/scp>\/<scp>II<\/scp> study of bortezomib\u2010melphalan\u2010prednisolone for previously untreated Japanese patients with multiple myeloma"],"prefix":"10.1111","volume":"104","author":[{"given":"Yoshiaki","family":"Ogawa","sequence":"first","affiliation":[{"name":"Department of Hematology and Oncology Tokai University School of Medicine Isehara Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenshi","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Hematology Japanese Red Cross Medical Center Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akira","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Research Institute for Radiation Biology and Medicine (RIRBM) Hiroshima University Hiroshima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinsuke","family":"Iida","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology and Immunology Nagoya City University Graduate School of Medical Sciences Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michinori","family":"Ogura","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology Nagoya Daini Red Cross Hospital Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kensei","family":"Tobinai","sequence":"additional","affiliation":[{"name":"Department of Hematology and Hematopoietic Stem Cell Transplantation National Cancer Center Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morio","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Hematology National Hospital Organization Nishigunma National Hospital Shibukawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kosei","family":"Matsue","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology Department of Medicine Kameda Medical Center Kamogawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhito","family":"Terui","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology\/Hematology Cancer Institute Hospital of the Japanese Foundation for Cancer Research Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuteru","family":"Ohashi","sequence":"additional","affiliation":[{"name":"Hematology Division Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masami","family":"Ishii","sequence":"additional","affiliation":[{"name":"Clinical Science Division Janssen Pharmaceutical K.K. 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