Detalle Publicación

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

Autores: Caballero-Velazquez, T.; Calderon-Cabrera, C.; Lopez-Corral, L.; Puig, N.; Marquez-Malaver, F.; Perez-Lopez, E.; Garcia-Calderon, C.; Rosso-Fernandez, C. M.; Barrigon, D. C.; Martin, J.; Mateos, M. V. ; San Miguel Izquierdo, Jesús; Perez-Simon, J. A. (Autor de correspondencia); European Myeloma Network
ISSN: 0268-3369
Volumen: 55
Número: 2
Páginas: 419 - 430
Fecha de publicación: 2020
This 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.