drugset / Trial / NCT00571493

VELCADE®-BEAM and Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin's Lymphoma, or Mantle Cell Lymphoma

NCT00571493

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I/II trial designed to study the toxicity and Maximum Tolerated Dose (MTD) of bortezomib in combination with BEAM (carmustine (BCNU), etoposide, cytarabine, melphalan) and autologous hematopoietic stem cell transplantation (ASCT) and to obtain a preliminary estimate of the response rate to this combination.

Timeline

Start
2006-04-14
Primary completion
2014-11-01
Completion
2014-11-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 0.8 mg/m2
Subject Bortezomib Small molecule 1 mg/m2
Subject Bortezomib Small molecule 1.3 mg/m2
Subject Bortezomib Small molecule 1.5 mg/m2
Background Cytarabine Small molecule 100 mg/m2
Background Etoposide Small molecule 100 mg/m2
Background Melphalan Small molecule 140 mg/m2
Background carmustine Small molecule 300 mg/m2

Indications