Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute