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Study of Thiotepa Combination With Melphalan (TM Protocol) Conditioning for Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma:A Prospective Randomized Controlled Clinical Trial
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2026-04-20
Completion Date
2028-10-20
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
Thiotepa and Melphalan
thiotepa and melphalan conditioning
Melphalan
melphalan conditioning