Multiple Myeloma Clinical Trial
Official title:
Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy
The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.
The primary objectives of this study are:
- To determine the 2 year-progression free survival in multiple myeloma with an allogeneic
transplant using a conditioning regimen of melphalan + fludarabine + Bortezomib in
patients < 60 years of age and available HLA-matched donor and compare it with the 2
year-progression-free-survival after an autologous stem cell transplant with
melphalan+Bortezomib conditioning in patients < 60 years.
- To determine the 2 year-progression free survival in multiple myeloma with an autologous
stem cell transplant using a conditioning regimen of melphalan + Bortezomib. for
patients > 60 years of age and patients < 60 years of age who decline allogeneic stem
cell transplant.
The secondary objectives of this study are:
- To determine the overall survival in multiple myeloma with autologous or allogeneic stem
cell transplants using the above conditioning regimens
- To determine the response rates in multiple myeloma using the above regimens.
- To determine minimal residual disease status using allele specific oligonucleotides
(ASO-PCR) by PCR and flow-cytometry for multiple myeloma cells.
- To correlate minimal residual disease status with 2 year progression free survival and
overall survival.
- To determine the incidence of acute and chronic graft-versus-host disease (GVHD) in
multiple myeloma with allogeneic stem cell transplant using the above conditioning
regimen.
- To examine quality of life in patients treated with allogeneic and autologous stem cell
transplants using the above conditioning regimen.
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