Spots Global Cancer Trial Database for Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma

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Trial Identification

Brief Title: Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma

Official Title: Evaluation of Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma After Cytoreductive Therapy

Study ID: NCT00948922

Conditions

Multiple Myeloma

Interventions

Bortezomib

Melphalan

Autologous Stem Cell Transplant

Fludarabine

Allogeneic Stem Cell Transplant

Study Description

Brief Summary: The purpose of this study is to evaluate the effectiveness of Bortezomib when added to standard chemotherapy medicine(s) for treatment of Multiple Myeloma.

Detailed Description: 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.