{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T09:41:11Z","timestamp":1789638071012,"version":"4.0.0"},"reference-count":32,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2011,9,1]],"date-time":"2011-09-01T00:00:00Z","timestamp":1314835200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2012,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND:<\/jats:title><jats:p>Bortezomib is active for newly diagnosed and relapsed multiple myeloma, and it has synergistic activity with melphalan. The authors of this report conducted a randomized trial to determine the safety and efficacy of adding bortezomib to a preparative regimen of arsenic trioxide (ATO), ascorbic acid (AA), and melphalan.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS:<\/jats:title><jats:p>Among 60 patients who enrolled between October 2006 and September 2007, 58 patients underwent autologous transplantation with a preparative regimen of melphalan 200 mg\/m<jats:sup>2<\/jats:sup> intravenously, AA 1000 mg daily intravenously for 7 days, and ATO 0.25 mg\/kg intravenously for 7 days. Patients were randomized to receive no bortezomib (Group 1), bortezomib 1 mg\/m<jats:sup>2<\/jats:sup> \u00d7 3 doses (Group 2), and bortezomib 1.5 mg\/m<jats:sup>2<\/jats:sup> \u00d7 3 doses (Group 3). Primary endpoints were complete response (CR), grade IV toxicity, and 90\u2010day treatment\u2010related mortality (TRM). Secondary endpoints were progression\u2010free survival (PFS) and overall survival (OS).<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>The median follow\u2010up of all surviving patients was 36 months (range, 20\u201043 months). The CR rates in Groups 1, 2, and 3 were 20%, 10%, and 10%, respectively. Grade 3 and 4 nonhematologic toxicities and TRM were comparable. The median OS was not reached in the groups, whereas the median PFS in Groups 1, 2, and 3 was 17.8 months, 17.4 months, and 20.7 months, respectively. PFS and OS were significantly shorter in patients who had high\u2010risk cytogenetics (<jats:italic>P<\/jats:italic> = .016 and <jats:italic>P<\/jats:italic> = .0001, respectively) and relapsed disease (<jats:italic>P<\/jats:italic> = .0001 and <jats:italic>P<\/jats:italic> = .0001, respectively) regardless of the treatment group.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS:<\/jats:title><jats:p>Adding bortezomib to a preparative regimen of ATO, AA, and high\u2010dose melphalan was safe and well tolerated in patients with multiple myeloma. There was no significant improvement in the CR rate, PFS, or OS in the bortezomib groups. Cancer 2012;. \u00a9 2011 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.26517","type":"journal-article","created":{"date-parts":[[2011,9,1]],"date-time":"2011-09-01T16:16:30Z","timestamp":1314893790000},"page":"2507-2515","source":"Crossref","is-referenced-by-count":38,"title":["A randomized phase 2 trial of a preparative regimen of bortezomib, high\u2010dose melphalan, arsenic trioxide, and ascorbic acid"],"prefix":"10.1002","volume":"118","author":[{"given":"Manish","family":"Sharma","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hassan","family":"Khan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter F.","family":"Thall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert Z.","family":"Orlowski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Roland L.","family":"Bassett","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Shah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qaiser","family":"Bashir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simrit","family":"Parmar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jatin J.","family":"Shah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chitra M.","family":"Hosing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uday R.","family":"Popat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio A.","family":"Giralt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard E.","family":"Champlin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muzaffar H.","family":"Qazilbash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2011,9]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra041875"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.3816\/CLM.2009.n.056"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199607113350204"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022340"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1038\/bmt.2010.160"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.20294"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V99.3.731"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbmt.2006.12.448"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa030288"},{"key":"e_1_2_6_11_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa043445"},{"key":"e_1_2_6_12_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.22.2679"},{"key":"e_1_2_6_13_2","first-page":"1136","article-title":"The proteasome inhibitor PS\u2010341 markedly enhances sensitivity of multiple myeloma tumor cells to chemotherapeutic agents","volume":"9","author":"Ma MH","year":"2003","journal-title":"Clin Cancer Res."},{"key":"e_1_2_6_14_2","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2002-06-1768"},{"key":"e_1_2_6_15_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0801479"},{"key":"e_1_2_6_16_2","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1182\/blood-2009-06-229658","article-title":"Intergroupe Francophone du Myelome (IFM). 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