Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan
Primary Efficacy and safety of the procedure in terms of number of remissions, survival,
event-free survival, relapse risk, and early transplant-related mortality (up to day +100).
Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the
presence of transplant-related complications (infections, sinusoidal occlusive syndrome and
others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk,
disease-free and overall survival after ASCT
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.
Within the first three months after transplant
Miguel A Sanz, MD
S: de Hematología. Hospital La Fe, Valencia. Spain
Spain: Ethics Committee