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We evaluated tolerability and efficacy of adding post\u2010transplant bortezomib consolidation (BC) or maintenance (BM) to this regimen in CALGB\/Alliance 50403, a randomized phase II trial. Following augmented\u2010dose R\u2010CHOP\/ methotrexate, high\u2010dose cytarabine\u2010based stem cell mobilization, cyclophosphamide\/carmustine\/etoposide (CBV) autotransplant, and rituximab, patients were randomized to BC (1.3 mg\/m<jats:sup>2<\/jats:sup> IV days 1, 4, 8, 11 of a 3\u2010week\u2009cycle for four cycles) or BM (1.6 mg\/m<jats:sup>2<\/jats:sup> IV once weekly\u2009\u00d7\u20094 every 8\u2009weeks for 18\u2009months) beginning day 90. The primary endpoint was PFS, measured from randomization for each arm. Proliferation signature, Ki67, and postinduction minimal residual disease (MRD) in bone marrow were assessed. Of 151 patients enrolled; 118 (80%) underwent ASCT, and 102 (68%) were randomized. Both arms met the primary endpoint, with median PFS significantly greater than 4\u2009years (<jats:italic>P<\/jats:italic> &lt;\u2009.001). The 8\u2010year PFS estimates in the BC and BM arms were 54.1% (95% CI 40.9%\u201071.5%) and 64.4% (95% 51.8%\u201079.0%), respectively. Progression\u2010free survival was significantly longer for transplanted patients on 50403 compared with those on 59909. Both the PFS and OS were significantly better for those who were MRD\u2010negative post\u2010induction. The high risk proliferation signature was associated with adverse outcome. Both BM and BC were efficacious and tolerable, although toxicity was significant. The comparison between studies 50403 and 59909 with long\u2010term follow up suggests a PFS benefit from the addition of BC or BM post\u2010 transplant.<\/jats:p>","DOI":"10.1002\/ajh.25783","type":"journal-article","created":{"date-parts":[[2020,3,14]],"date-time":"2020-03-14T06:54:47Z","timestamp":1584168887000},"page":"583-593","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["Bortezomib consolidation or maintenance following immunochemotherapy and autologous stem cell transplantation for mantle cell lymphoma: <scp>CALGB<\/scp>\/Alliance 50403"],"prefix":"10.1002","volume":"95","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6060-5536","authenticated-orcid":false,"given":"Lawrence D.","family":"Kaplan","sequence":"first","affiliation":[{"name":"Medicine\/Hematology\u2010Oncology University of California, San Francisco  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1867-0526","authenticated-orcid":false,"given":"Matthew J.","family":"Maurer","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wendy","family":"Stock","sequence":"additional","affiliation":[{"name":"Medicine, University of Chicago Comprehensive Cancer Center  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy L.","family":"Bartlett","sequence":"additional","affiliation":[{"name":"Siteman Cancer Center Washington University School of Medicine  St Louis Missouri USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noreen","family":"Fulton","sequence":"additional","affiliation":[{"name":"Medicine, University of Chicago Comprehensive Cancer Center  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adam","family":"Pettinger","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John C.","family":"Byrd","sequence":"additional","affiliation":[{"name":"Hematology, The Ohio State University  Columbus Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristie A.","family":"Blum","sequence":"additional","affiliation":[{"name":"Hematology, The Ohio State University  Columbus Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ann S.","family":"LaCasce","sequence":"additional","affiliation":[{"name":"Medical Oncology Dana\u2010Farber\/Partners CancerCare  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric D.","family":"Hsi","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Cleveland Clinic  Cleveland Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi Tian","family":"Liu","sequence":"additional","affiliation":[{"name":"Centre for Lymphoid Cancer, British Columbia Cancer  Vancouver British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David W.","family":"Scott","sequence":"additional","affiliation":[{"name":"Centre for Lymphoid Cancer, British Columbia Cancer  Vancouver British Columbia Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Hurd","sequence":"additional","affiliation":[{"name":"Hematology\u2010Oncology Wake Forest University Health Sciences  Winston\u2010Salem North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy S.","family":"Ruppert","sequence":"additional","affiliation":[{"name":"Alliance Statistics and Data Center The Ohio State University  Columbus Ohio USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco","family":"Hernandez\u2010Ilizaliturri","sequence":"additional","affiliation":[{"name":"Roswell Park Comprehensive Cancer Center  Buffalo New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John P.","family":"Leonard","sequence":"additional","affiliation":[{"name":"Department of Medicine Weill Medical College of Cornell University  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce D.","family":"Cheson","sequence":"additional","affiliation":[{"name":"Hematology\u2010Oncology MedStar Georgetown University Hospital  Washington District of Columbia 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