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Blood, 1 November 2008, Vol. 112, No. 9, pp. 3591-3593.
Prepublished online as a Blood First Edition Paper on July 8, 2008; DOI 10.1182/blood-2008-02-141598.


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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

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

Laura Rosiñol1, José Antonio Pérez-Simón2, Anna Sureda3, Javier de la Rubia4, Felipe de Arriba5, Juan José Lahuerta6, José David González7, Joaquín Díaz-Mediavilla8, Belén Hernández9, Javier García-Frade10, Dolores Carrera11, Angel León12, Miguel Hernández13, Pascual Fernández Abellán14, Juan Miguel Bergua15, Jesús San Miguel2, Joan Bladé1, for Programa para el Estudio y la Terapéutica de las Hemopatías Malignas y Grupo Español de Mieloma (PETHEMA/GEM)

1 Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona; 2 Hospital Clínico/Centro de Investigación del Cáncer, Salamanca; 3 Hospital de la Santa Creu i Sant Pau, Barcelona; 4 Hospital La Fe, Valencia; 5 Hospital Morales Messeguer, Murcia; 6 Hospital Doce de Octubre, Madrid; 7 Hospital Materno-Insular, Las Palmas de Gran Canaria; 8 Hospital Clínico San Carlos, Madrid; 9 Hospital General Ciudad Real, Ciudad Real; 10 Hospital Rio Hortega, Valladolid; 11 Hospital de Asturias, Oviedo; 12 Hospital de Jerez de la Frontera, Jerez; 13 Hospital Universitario Canarias, Sta Cruz de Tenerife; 14 Hospital de Alicante, Alicante; and 15 Hospital San Pedro de Alcántara, San Pedro de Alcántara, Spain

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 [ClinicalTrials.gov]


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