Clinical Trial: Bortezomib Followed by High-Dose Melphalan and Bortezomib as Conditioning Regimen for Tandem Stem Cell Transplants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ref

Brief 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

Detailed Summary: 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.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Overall Survival (OS) [ Time Frame: 40 months post transplant ]

Median overall survival after first peripheral blood stem cell transplant (PBSCT).


Original Primary Outcome:

  • maximum tolerated dose (MTD)
  • response rate
  • safety
  • tolerability


Current Secondary Outcome:

Original Secondary Outcome:

  • gene expression profiles (pharmacogenomics)
  • time to disease progression
  • overall survival


Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: March 23, 2006
Date Started: June 2005
Date Completion:
Last Updated: January 20, 2017
Last Verified: August 2013