213
Participants
Start Date
October 31, 2003
Primary Completion Date
July 31, 2008
Study Completion Date
December 31, 2010
Thalidomide plus dexamethasone
"D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression.~The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event."
Dexamethasone
dexamethasone alone 40 mg/day for 4 days every 28 days
Hospital Universitário Clementino Fraga Filho, Rio de Janeiro
Universidade Estadual de Campinas, Campinas
Universidade de São Paulo- Ribeirão Preto, Ribeirão Preto
Santa Casa de Misericórdia de São Paulo, São Paulo
Grupo de Estudos Multicentricos em Onco-Hematologia
NETWORK