60
Participants
Start Date
April 30, 2004
Primary Completion Date
January 31, 2007
Study Completion Date
December 31, 2008
Velcade
Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)
Melphalan
Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II
Prednisone
Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)
Hospital Clínic, Barcelona
Hospital de la Santa Creu i Sant Pau, Barcelona
Hospital Germans Trias i Pujol, Barcelona
Hospital Universitario de Canarias, Santa Cruz de Tenerife
Hospital Clínico San Carlos de Madrid, Madrid
Hospital Doce de Octubre, Madrid
Hospital Ramón y Cajal, Madrid
Hospital Universitario de la Princesa, Madrid
Hospital Son Llatzer, Palma de Mallorca
Hospital Morales Messeguer, Murcia
Clínica Universitaria de Navarra, Pamplona
Hospital Central de Asturias, Oviedo
Hospital Clínic, Valencia
Hospital La Fe, Valencia
Hospital Universitario Dr. Peset, Valencia
Hospital Clínico Lozano Blesa, Zaragoza
Hospital Virgen Blanca de León, León
Hospital Clínico Universitario de Salamanca, Salamanca
Hospital General de Segovia, Segovia
Collaborators (1)
Millennium Pharmaceuticals, Inc.
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
PETHEMA Foundation
OTHER