{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T22:59:32Z","timestamp":1790895572553,"version":"4.1.0"},"reference-count":6,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"2","license":[{"start":{"date-parts":[[2021,4,1]],"date-time":"2021-04-01T00:00:00Z","timestamp":1617235200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2020,6,23]],"date-time":"2020-06-23T00:00:00Z","timestamp":1592870400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001843","name":"Science and Engineering Research Board","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001843","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2021,4]]},"abstract":"\n Background:<\/jats:title>\n Most data on autologous hematopoietic cell transplantation (auto-HCT) in myeloma are based on the use of innovator formulation of melphalan. Comparative bioequivalence and efficacy studies of generic melphalan are lacking.<\/jats:p>\n <\/jats:sec>\n \n Methods:<\/jats:title>\n \n In this retrospective study, we report long-term outcomes of auto-HCT in myeloma using innovator (Alkeran, Aspen Pharma;\n n<\/jats:italic>\n = 41) and generic melphalan (Alkacel, Celon Labs, India;\n n<\/jats:italic>\n = 55) formulations. All consecutive patients at a single center from the period 2011\u20132018 were included.\n <\/jats:p>\n <\/jats:sec>\n \n Results:<\/jats:title>\n \n The median follow-up in the innovator and generic groups was 61.7 and 32.5 months, respectively. Both groups were matched for age, sex, stage, and myeloma response. There were significantly more patients in the innovator melphalan group who were administered mel- phalan at a reduced dose at physician discretion (26.8% vs. 3.6%,\n p<\/jats:italic>\n = .001). There were significantly more patients with grade 3 or higher mucositis (68.3% vs. 38.1%,\n p<\/jats:italic>\n < .0001) and grade 3 or higher diarrhea (85.4% vs. 50.1%,\n p<\/jats:italic>\n < .0001) in the innovator group. The median duration of hospital stay was significantly longer in the innovator group (19 days vs. 15.5 days,\n p<\/jats:italic>\n < .0001). There were significantly more patients in the generic group who received standard maintenance (94.5% vs. 34.1%,\n p<\/jats:italic>\n < .0001). Despite the differences in the melphalan dose and post-transplant strategies, the 4-year progression-free survival and overall survival were not significantly different in the two groups (58% vs. 63%,\n p<\/jats:italic>\n = .7, 71% vs. 72%,\n p<\/jats:italic>\n = .4, respectively).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion:<\/jats:title>\n Long-term efficacy comparison is helpful in the absence of postmarketing bioequivalence studies of generic melphalan.<\/jats:p>\n <\/jats:sec>","DOI":"10.1016\/j.hemonc.2020.06.002","type":"journal-article","created":{"date-parts":[[2020,6,25]],"date-time":"2020-06-25T11:51:28Z","timestamp":1593085888000},"page":"114-118","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":5,"title":["Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma"],"prefix":"10.4103","volume":"14","author":[{"given":"Deepesh P.","family":"Lad","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pankaj","family":"Malhotra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amol N.","family":"Patil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ram V.","family":"Nampoothiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kripa Shanker","family":"Kasudhan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alka","family":"Khadwal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaurav","family":"Prakash","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arihant","family":"Jain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Malhotra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neelam","family":"Varma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Savita Verma","family":"Attri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subhash","family":"Varma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","reference":[{"key":"R1-5-20241211","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1038\/s41408-019-0205-9","article-title":"Current status of autologous stem cell transplantation for multiple myeloma","volume":"9","author":"Al Hamed","year":"2019","journal-title":"Blood Cancer J"},{"key":"R2-5-20241211","doi-asserted-by":"crossref","DOI":"10.1016\/j.clml.2019.08.013","article-title":"Pharmacokinetics and efficacy of generic melphalan is comparable to innovator formulation in patients with multiple myeloma undergoing autologous stem cell transplantation","volume":"20","author":"Pai","year":"2020","journal-title":"Clin Lymphoma Myeloma Leuk"},{"key":"R3-5-20241211","doi-asserted-by":"crossref","first-page":"2088","DOI":"10.1038\/s41409-019-0631-0","article-title":"Impact of frailty, melphalan pharmacokinetics, and pharmacogenetics on outcomes post autologous hematopoietic cell transplantation for multiple myeloma","volume":"54","author":"Nampoothiri","year":"2019","journal-title":"Bone Marrow Transplant"},{"key":"R4-5-20241211","doi-asserted-by":"crossref","first-page":"4691","DOI":"10.1182\/blood-2010-10-299487","article-title":"Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1","volume":"117","author":"Rajkumar","year":"2011","journal-title":"Blood"},{"key":"R5-5-20241211","first-page":"639","article-title":"Generic (bioequivalent) melphalan has similar efficacy and toxicity but lower cost in the conditioning regimen for autologous hematopoietic stem cell transplantation. Physicians Poster Sessions","volume":"50","author":"Topcuoglu","year":"2015","journal-title":"Bone Marrow Transplant"},{"key":"R6-5-20241211","doi-asserted-by":"crossref","first-page":"149","DOI":"10.1111\/bcp.12906","article-title":"High melphalan exposure is associated with improved overall survival in myeloma patients receiving high dose melphalan and autologous transplantation","volume":"82","author":"Nath","year":"2016","journal-title":"Br J Clin Pharmacol"}],"container-title":["Hematology\/Oncology and Stem Cell Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1658387620301138?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1658387620301138?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ovid.com\/10.1016\/j.hemonc.2020.06.002","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T13:49:05Z","timestamp":1787838545000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.1016\/j.hemonc.2020.06.002"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4]]},"references-count":6,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.1016\/j.hemonc.2020.06.002","relation":{},"ISSN":["1658-3876"],"issn-type":[{"value":"1658-3876","type":"print"}],"subject":[],"published":{"date-parts":[[2021,4]]}}}