Thiotepa and Melphalan
Otherthiotepa and melphalan conditioning
NCT Number: NCT07542418
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
thiotepa and melphalan conditioning
melphalan conditioning
Time frame: one year after autologous stem cell transplantation
relapse rate at one year after ASCT
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
the time of recovery of neutrophil and platelet
Time frame: one month after ASCT
strict complete remission rate
Time frame: time from diagnosis to the end of follow-up or death which comes first
overall survival
Time frame: time after ASCT to the end of follow-up or disease relapse which comes first
progress free survival
Time frame: rate of death without disease relapse
non relapse mortality
Time frame: within one month after ASCT
Adverse events
Contact information is provided by the study sponsor or research team.
First Affiliated Hospital Xi'an Jiaotong University
Other
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