Clinical Trial

Study of Thiotepa Combination With Melphalan (TM Protocol) Conditioning for Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma:A Prospective Randomized Controlled Clinical Trial

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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.
Trial Details
NCT Number NCT07542418
Lead Sponsor First Affiliated Hospital Xi'an Jiaotong University
Conditions Multiple Myeloma
Enrollment 204 participants
Start Date 2026-04-20
Primary Completion 2028-04-20 (estimated)
Study Completion 2028-10-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-21