A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma - PubMed (original) (raw)

Clinical Trial

. 2008 Nov 1;112(9):3591-3.

doi: 10.1182/blood-2008-02-141598. Epub 2008 Jul 8.

José Antonio Pérez-Simón, Anna Sureda, Javier de la Rubia, Felipe de Arriba, Juan José Lahuerta, José David González, Joaquín Díaz-Mediavilla, Belén Hernández, Javier García-Frade, Dolores Carrera, Angel León, Miguel Hernández, Pascual Fernández Abellán, Juan Miguel Bergua, Jesús San Miguel, Joan Bladé; Programa para el Estudio y la Terapéutica de las Hemopatías Malignas y Grupo Español de Mieloma (PETHEMA/GEM)

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Clinical Trial

A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma

Laura Rosiñol et al. Blood. 2008.

Free article

Abstract

One hundred ten patients with multiple myeloma (MM) failing to achieve at least near-complete remission (nCR) after a first autologous stem cell transplantation (ASCT) were scheduled to receive a second ASCT (85 patients) or a reduced-intensity-conditioning allograft (allo-RIC; 25 patients), depending on the human leukocyte antigen (HLA)-identical sibling donor availability. There was a higher increase in complete remission (CR) rate (40% vs 11%, P = .001) and a trend toward a longer progression-free survival (PFS; median, 31 months vs not reached, P = .08) in favor of allo-RIC. In contrast, it was associated with a trend toward a higher transplantation-related mortality (16% vs 5%, P = .07), a 66% chance of chronic graft-versus-host disease and no statistical difference in event-free survival and overall survival. Although the PFS plateau observed with allo-RIC is very encouraging, this procedure is associated with high morbidity and mortality, and therefore it should still be considered investigational and restricted to well-designed prospective clinical trials. This trial is registered at ClinicalTrials.gov ID number NCT00560053.

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