NCT00804947

Autologous Stem Cell Transplant (ASCT) With Intravenous Busulfan and Melphalan as Conditioning Regimen

Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fundacion Para La Investigacion Hospital La Fe · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.

Detailed description

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Intravenous busulfan and melphalan	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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-12-09
• Last updated: 2008-12-09

Locations

6 sites across 1 country: Spain