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
Study ID
NCT07542418
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Thiotepa and Melphalan — OTHER
    thiotepa and melphalan conditioning
  • Melphalan — OTHER
    melphalan conditioning

Study Details

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 Dates

First listed
Apr 21, 2026
Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Apr 20, 2028
Completion
Oct 20, 2028

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    total thiotepa 10 mg/kg, D-4 to -3; melphalan 140mg/m2, D-2 The eGFR was lower than 30ml/min, and the total dosage of thiotepa was 5mg/kg, melphalan was 100mg/m2 The eGFR ranged from 30 to 60 ml/min, and the total dosage of thiotepa was 7.5 mg/kg, and melphalan was 120 mg/m2
  • Other: Control group
    melphalan 200mg/m2, D-2 The eGFR was lower than 30ml/min, melphalan was 120mg/m2 The eGFR ranged from 30 to 60 ml/min, and melphalan was 140 mg/m2

Primary Outcome Measure

relapse rate [ Time Frame: one year after autologous stem cell transplantation ]

Central Contacts

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