UARK 2007-01, A Phase II Pilot Study of the Combination of Melphalan, Bortezomib, Thalidomide and Dexamethasone (MEL-VTD) and Autologous Transplantation for Patients Relapsing or Progressing After Tandem Transplantation
Autologous transplant is now considered a standard treatment for many patients with multiple
myeloma. An autologous transplant is a procedure in which stem cells are removed from a
patient and then given back to the patient following intensive treatment. Doctors remove
healthy stem cells from a patient's circulating blood system and store them before the
patient receives high-dose chemotherapy. The stem cells are then returned to the patient,
where they can produce new blood cells to replace cells destroyed by the treatment. The drug
usually used before transplant is melphalan alone in 1 or 2 high doses. In past studies
conducted at UAMS, researchers have shown that a chemotherapy treatment regimen called "VTD"
is effective in patients with multiple myeloma who have failed previous treatments. VTD is
a combination of drugs consisting of VelcadeTM (also known as bortezomib), Thalidomide, and
Dexamethasone. In this study, researchers want to find out if using the VTD regimen, along
with higher doses melphalan, in subjects who have relapsed or progressed after previous
transplant(s) can be given safely to subjects who have failed previous transplant(s).
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
VTD regimen with melphalan
To find out if using the VTD regimen, along with higher doses melphalan, in subjects who have relapsed or progressed after previous transplant(s), can be given safely to subjects who have failed previous transplant(s).
Mauricio Pineda-Roman, MD
University of Arkansas
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|