Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy
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 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
progression free survival with allogeneic stem cell transplant in multiple myeloma using melphalan+fludarabine+bortezomib as the conditioning regimen
two years
No
Melissa Alsina, MD
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
MCC 15697
NCT00948922
June 2009
July 2013
Name | Location |
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H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |