Multiple Myeloma Clinical Trial
Official title:
An Evaluation of Bortezomib (VelcadeR ) Followed by High-Dose Melphalan and Bortezomib (VelcadeR) as Conditioning Regimen for Tandem Peripheral Blood Stem Cell Transplants in Patients With Primary Refractory Multiple Myeloma and Plasma Cell Leukemia
The primary objectives of this study are to:
- To determine the maximum tolerated dose (MTD) of bortezomib in combination with
high-dose melphalan as a conditioning regimen.
- To determine the safety, tolerability, and response rates of bortezomib given in
combination with high-dose melphalan, as a conditioning regimen, for tandem transplants
in patients with primary refractory multiple myeloma or plasma cell leukemia.
The secondary objectives of this study are to:
- To determine gene expression profiles (pharmacogenomics) and perform RTPCR for Fanconi
anemia pathway genes, prior to and after treatment with bortezomib, in patients with
primary refractory multiple myeloma and plasma cell leukemia and correlate profiles
with responses to treatment.
- To determine the time to disease progression and overall survival in patients with
primary refractory multiple myeloma and plasma cell leukemia treated with bortezomib
followed by tandem autologous transplantation
- To determine the response rates of 2 cycles of bortezomib in patients with primary
refractory multiple myeloma or plasma cell leukemia
Patients with primary refractory multiple myeloma or plasma cell leukemia either newly diagnosed or previously treated will receive 2-cycles of standard dose bortezomib followed by high-dose melphalan and bortezomib as a conditioning regimen prior to a tandem autologous peripheral blood stem cell transplantation (PBSCT). Following treatment with two cycles of standard dose bortezomib, sequential cohorts of patients will be given escalating bortezomib doses combined with standard and constant conditioning regimen doses of melphalan. Once the MTD of bortezomib is reached, that dose will be administered in combination with melphalan as conditioning prior to PBSCT. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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