{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T07:36:20Z","timestamp":1782804980136,"version":"3.54.5"},"reference-count":45,"publisher":"American Society of Hematology","issue":"15","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2025,10,9]]},"abstract":"<jats:sec>\n                  <jats:title>Abstract<\/jats:title>\n                  <jats:p>In retrospective studies, autologous stem cell transplantation (ASCT) conditioning with intravenous busulfan and melphalan (BUMEL) led to longer progression-free survival (PFS) than melphalan alone (MEL200). We compared long-term outcomes of BUMEL vs MEL200 in the context of intensified bortezomib, lenalidomide, and dexamethasone (VRD) induction and consolidation therapies. GEM12 was a phase 3 trial for patients with newly diagnosed multiple myeloma (NDMM) eligible for ASCT including 6 reinforced VRD cycles followed by ASCT conditioned with BUMEL or MEL200 and 2 VRD consolidation cycles. The primary end point was PFS. Subgroup analyses were based on International Staging System (ISS) stages and high-risk genetic abnormalities. Patients were randomized with an open-label 2 \u00d7 2 factorial design and 1:1:1:1 allocation ratio to ensure the balance between the GEM12 and the subsequent phase 3 GEM14 trial. Between 2013 and 2015, 458 patients were randomized (BUMEL, n = 230; MEL200, n = 228). The 10\u207b\u2076 MRD-negative rate was 63%, 68% for BUMEL vs 58% for MEL200 (odds ratio, 1.51; P = .035). The median PFS was 89 months for BUMEL and 73.1 for MEL200 (hazard ratio, 0.89 [95% confidence interval, 0.70-1.14]; P = .3). BUMEL showed benefit for patients with ISS stages II or III, t(14;16), and del(1p). For subcohorts ISS stages II or III treated with BUMEL and ISS I treated with MEL200 the median PFS was 96.5 months (95% confidence interval, 76 to not estimable). No safety concerns were observed. After a median follow-up of 8.4 years, GEM2012 demonstrated one of the longest PFS values reported in patients with NDMM, with significant differences favoring BUMEL in advanced ISS stages. The trial was registered at www.ClinicalTrials.gov as #NCT01916252 and at European Union Drug Regulating Authorities Clinical Trials as EudraCT 2012-005683-10.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1182\/blood.2025028313","type":"journal-article","created":{"date-parts":[[2025,6,11]],"date-time":"2025-06-11T15:31:07Z","timestamp":1749655867000},"page":"1747-1758","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":5,"title":["High-dose busulfan-melphalan vs melphalan and reinforced VRD for newly diagnosed multiple myeloma: a phase 3 GEM trial"],"prefix":"10.1182","volume":"146","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3393-9570","authenticated-orcid":false,"given":"Juan Jos\u00e9","family":"Lahuerta","sequence":"first","affiliation":[{"name":"1Hematology Department, Instituto de Investigaci\u00f3n Hospital Universitario 12 de Octubre, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6576-7881","authenticated-orcid":false,"given":"Jes\u00fas","family":"San-Miguel","sequence":"additional","affiliation":[{"name":"2Hematology Department, Cancer Center Cl\u00ednica Universitaria de Navarra, Centre for Applied Medical Research, Centre for Biomedical Research in the Cancer Network, Institute for Research in Neurological Disabilities of Castilla-La Mancha, Pamplona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Jim\u00e9nez-Ubieto","sequence":"additional","affiliation":[{"name":"3Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3774-118X","authenticated-orcid":false,"given":"Rafael","family":"Alonso","sequence":"additional","affiliation":[{"name":"3Hematology Department, Hospital Universitario 12 de Octubre, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1977-3815","authenticated-orcid":false,"given":"Bruno","family":"Paiva","sequence":"additional","affiliation":[{"name":"2Hematology Department, Cancer Center Cl\u00ednica Universitaria de Navarra, Centre for Applied Medical Research, Centre for Biomedical Research in the Cancer Network, Institute for Research in Neurological Disabilities of Castilla-La Mancha, Pamplona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7535-3861","authenticated-orcid":false,"given":"Noem\u00ed","family":"Puig","sequence":"additional","affiliation":[{"name":"4Hematology Department, Hospital Universitario de Salamanca, Salamanca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Teresa","family":"Cedena","sequence":"additional","affiliation":[{"name":"5Hematology Department, Hospital Universitario 12 de Octubre, Instituto de Investigaci\u00f3n Biom\u00e9dica i+12, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5834-9510","authenticated-orcid":false,"given":"Norma Carmen","family":"Gutierrez","sequence":"additional","affiliation":[{"name":"6Hematology Department, Hospital Universitario de Salamanca, Institute of Biomedical Research of Salamanca, Cancer Research Center\u2013Institute for Molecular and Cellular Biology of Cancer, University of Salamanca\u2013Spanish National Research Council, Centre for Biomedical Research in the Cancer Network, Salamanca, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0374-3008","authenticated-orcid":false,"given":"Mar\u00eda Jos\u00e9","family":"Calasanz","sequence":"additional","affiliation":[{"name":"7Genetics 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