Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
BU is administered intravenously at a dose of 3.2 mg/kg over three hours once a day on days -5 to -3 (total dose 9.6 mg/kg), followed by MEL at a dose of 140 mg/m2 on day -2. After one day of rest, progenitor cells are infused on day 0.
Hospital Insular Canarias
Las Palmas de Gran Canaria, Las Palmas, Spain
RECRUITINGH La Princesa
Madrid, Madrid, Spain
RECRUITINGH. 12 de Octubre
Madrid, Madrid, Spain
The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.
Time frame: Within the first three months after transplant
Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival
Time frame: Up to 5 years after transplant
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S. de Hematología. Hospital La Fe
Valencia, Valencia, Spain
RECRUITINGHospital Clínico
Valencia, Valencia, Spain
RECRUITINGHospital Dr. Peset
Valencia, Valencia, Spain
RECRUITING