title: A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma.
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.
authors.affiliation: Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: Rosiñol
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Pérez-Simón
authors.forename: Anna
authors.initials: A
authors.lastname: Sureda
authors.forename: Javier
authors.initials: J
authors.lastname: de la Rubia
authors.forename: Felipe
authors.initials: F
authors.lastname: de Arriba
authors.forename: Juan José
authors.initials: JJ
authors.lastname: Lahuerta
authors.forename: José David
authors.initials: JD
authors.lastname: González
authors.forename: Joaquín
authors.initials: J
authors.lastname: Díaz-Mediavilla
authors.forename: Belén
authors.initials: B
authors.lastname: Hernández
authors.forename: Javier
authors.initials: J
authors.lastname: García-Frade
authors.forename: Dolores
authors.initials: D
authors.lastname: Carrera
authors.forename: Angel
authors.initials: A
authors.lastname: León
authors.forename: Miguel
authors.initials: M
authors.lastname: Hernández
authors.forename: Pascual Fernández
authors.initials: PF
authors.lastname: Abellán
authors.forename: Juan Miguel
authors.initials: JM
authors.lastname: Bergua
authors.forename: Jesús
authors.initials: J
authors.lastname: San Miguel
authors.forename: Joan
authors.initials: J
authors.lastname: Bladé
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols; D018572:Disease-Free Survival; D006086:Graft vs Host Disease / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009101:Multiple Myeloma / Q000628:therapy*; D011446:Prospective Studies; D033581:Stem Cell Transplantation / Q000009:adverse effects / Q000401:mortality; D019172:Transplantation Conditioning; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous