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Blood, 1 December 2005, Vol. 106, No. 12, pp. 3755-3759.
Prepublished online as a Blood First Edition Paper on August 16, 2005; DOI 10.1182/blood-2005-03-1301.
Previous Article | Next Article 
Submitted March 31, 2005
Accepted July 11, 2005
High-dose therapy intensification versus continued standard chemotherapy in multiple myeloma patients responding to the initial chemotherapy: long term results from a prospective randomized trial from the Spanish cooperative group PETHEMA
Joan Blade*, Laura Rosinol, Ana Sureda, Jose M Ribera, Joaquin Diaz-Mediavilla, Jose Garcia-Larana, M V Mateos, Luis Palomera, Javier Fernandez-Calvo, Josep M Marti, Pilar Giraldo, Felix Carbonell, Manel Callis, Jesus Trujillo, Santiago Gardella, M J Moro, Abelardo Barez, Alfons Soler, Llorenc Font, Montserrat Fontanillas, and Jesus San Miguel
Hospital Clinic, IDIBAPS, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
Hospital Clinico, Madrid, Spain
Hospital Ramon y Cajal, Madrid, Spain
Hospital Clinico/ Centro de Investigacion del Cancer, Salamanca, Spain
Hospital Clinico, Zaragoza, Spain
Hospital Clinico, Valladolid, Spain
Hospital Mutua de Terrassa, Terrassa, Spain
Hospital Miguel Servet, Zaragoza, Spain
Hospital General Universitario, Valencia, Spain
Hospital Vall d'Hebron, Barcelona, Spain
Hospital Carlos Haya, Malaga, Spain
Hospital Dr. Josep Trueta, Girona, Spain
Hematology, Hospital Virgen Blanca, Leon, Spain
Hospital Nuestra Senora de Sonsoles, Avila, Spain
Hematology, Hospital Parc Tauli, Sabadell, Spain
Hospital Verge de la Cinta, Tortosa, Spain
* Corresponding author; email: jblade{at}clinic.ub.es.
The aim of the present randomized trial was to compare HDT versus continued conventional chemotherapy in patients with MM responding to the initial treatment. From May 1994 to October 1999, 216 patients (122M/94F, stage II or III, ECOG < 3) entered the study. The initial chemotherapy consisted of 4 cycles of alternating VBMCP/VBAD. Responding patients were randomized to receive either 8 additional cycles of VBMCP/VBAD or intensification with melphalan 200 mg/m2 or melphalan 140 mg/m2 plus 12 Gys of fractionated TBI. One-hundred and sixty four patients were randomized, 83 to continued chemotherapy and 81 to HDT. Complete remission was significantly higher with HDT (30 vs 11%, p=0.002). However, progression-free survival (PFS) was not significantly different between HDT and conventional therapy (median, 42 vs 33 months, p=NS) and the overall survival (OS) was similar in both groups (median, 61 vs 66 months). Finally, the survival after relapse was identical in the two arms (15.9 vs. 16.4 months). In conclusion, these results show that HDT intensification when given to myeloma patients who have responded to the initial chemotherapy significantly increases complete remission rate but has no significant impact on PFS and OS.

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