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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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