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Title

Efficacy of bortezomib to intensify the conditioning regimen and the graft-versus-host disease prophylaxis for high-risk myeloma patients undergoing transplantation

AuthorsCaballero-Velázquez, Teresa; Calderón-Cabrera, Cristina; López-Corral, L.; Puig, Noemi; Márquez-Malaver, Francisco José; Pérez-López, Estefanía; García-Calderón, Clara B.; Rosso-Fernández, Clara; Caballero Barrigón, D.; Martín, J.; Mateos, Maria Victoria; San Miguel, Jesús F. CSIC ORCID; Pérez-Simón, José A.
KeywordsMyeloma
Phase I trials
Issue Date24-Sep-2019
PublisherSpringer Nature
CitationBone Marrow Transplantation 55: 419–430 (2019)
AbstractThis multicenter phase I trial was designed to evaluate the safety and efficacy of bortezomib (Bz) as part of both the conditioning regimen and the graft-versus-host disease (GvHD) prophylaxis. Patients received fludarabine, melphalan and Bz (days −9 and −2). GVHD prophylaxis consisted of Bz (days +1, +4, and +7), sirolimus (Siro) from day −5 and tacrolimus (Tk) from −3 (except the first five patients that did not receive Tk). Twenty-five patients with poor prognostic multiple myeloma were included. Eleven out of the 19 patients had high-risk features. Out of the 21 patients evaluable at day +100, 14 were in CR (67%) and 7 (33%) in PR. Cumulative incidence (CI) of nonrelapse mortality at 1 year was 24%. CI of grades 2–4 and 3–4 acute GvHD was 35% and 10%, respectively; CI of chronic GvHD was 35% and 55% at 1 and 2 years, respectively. Overall and event free survival at 2 years were 64% and 31%, respectively. Bz as part of the conditioning regimen and in the combination with Siro/tacrolimus for GvHD prophylaxis is safe and effective allowing an optimal disease control early after transplant and reducing the risk of GvHD.
Publisher version (URL)http://dx.doi.org/10.1038/s41409-019-0670-6
URIhttp://hdl.handle.net/10261/203167
DOI10.1038/s41409-019-0670-6
ISSN0268-3369
E-ISSN1476-5365
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