Multiple Myeloma Patients Who Candidate for Autologous Peripheral Blood Stem Cell Transplantation Clinical Trial
Official title:
A Phase 1/2, Open-label, Prospective, Multicenter Study to Evaluate the Efficacy and Safety of the Lower Dose of Bortezomib Plus Busulfan and Melphalan as a Conditioning Regimen in Patients With Multiple Myeloma Undergoing Autologous Peripheral Blood Stem Cell Transplantation- KMM103 Study
Despite the advantages of autologous stem cell transplantation (ASCT) over conventional
chemotherapy,1,2 the results of high-dose chemoradiotherapy in multiple myeloma (MM) are
still unsatisfactory with a 6-year event free survival (EFS) of only 24%.
Based on existing data, bortezomib-containing regimens are currently accepted at many
centers as an induction treatment option for patients with symptomatic MM, particularly if
it is planned to offer subsequent high-dose therapy with ASCT. So we will use
bortezomib-containing regimens as induction prior to this novel conditioning regimen. The
objective of the present study is to compare the toxicity and therapeutic efficacy of a new
high-dose regimen using dose-escalation of BOR, BU and MEL for ASCT in the Korean patients
with MM. The patients should be treated with bortezomib-containing regimens as an induction
therapy before ASCT. We will specifically analyze (i) the efficacy of the conditioning
regimen in improving the pre-ASCT status, response rate (ii) engraftment and
transplant-related mortality (TRM) and (iii) the impact on survival including
progression-free survival (PFS) and overall survival (OS).
Triple combination of conditioning will enhance the response rate after ASCT, and will
improve not only PFS, but also OS. We think that data from this study may further strengthen
feasibility of BOR in conditioning prior to ASCT.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment