A prospective PETHEMA study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma.
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.
Rosiñol
Laura
L
Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
Pérez-Simón
José Antonio
JA
Sureda
Anna
A
de la Rubia
Javier
J
de Arriba
Felipe
F
Lahuerta
Juan José
JJ
González
José David
JD
Díaz-Mediavilla
Joaquín
J
Hernández
Belén
B
García-Frade
Javier
J
Carrera
Dolores
D
León
Angel
A
Hernández
Miguel
M
Abellán
Pascual Fernández
PF
Bergua
Juan Miguel
JM
San Miguel
Jesús
J
Bladé
Joan
J
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