To explore the efficacy and safety of thiotepa combined with melphalan for ASCT conditioning in patients with multiple myeloma who did not acheive CR with or without extramedullary inflitration before transplantation. After screening and enrollment, the patients were randomly divided into two groups according to 1:1, and the experimental group received the following drug treatments: the total amount of thiotepa was 10mg/kg, D-4 to -3; melphalan 140mg/m2, D-2. The control group received melphalan 200mg/m2, D-2 (the dose of the drug was adjusted according to the glomerular filtration rate). The two groups of D0 infused hematopoietic stem cells.G-CSF and TPO or TPO-RA were allowed to use to promote hematopoietic stem cell engraftment.Platelet and red blood cell transfusions were allowed if necessary. Efficacy of the therapy was evaluated 1 month after the end of transplantation, and the follow-up evaluation was carried out every 3 months, and the relapse rate was evaluated until 1 year after transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
204
thiotepa and melphalan conditioning
melphalan conditioning
relapse rate
relapse rate at one year after ASCT
Time frame: one year after autologous stem cell transplantation
hematopoietic recovery time
the time of recovery of neutrophil and platelet
Time frame: the first day of neutrophil more than 0.5X 10*9/L and Platelet more than 20X 10*9/L without transfusion after ASCT
sCR rate
strict complete remission rate
Time frame: one month after ASCT
OS
overall survival
Time frame: time from diagnosis to the end of follow-up or death which comes first
PFS
progress free survival
Time frame: time after ASCT to the end of follow-up or disease relapse which comes first
NRM
non relapse mortality
Time frame: rate of death without disease relapse
Adverse events
Adverse events
Time frame: within one month after ASCT
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