Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07542418

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1) Age 18-70 years old, gender is not limited; 2) Patients with confirmed multiple myeloma; 3) CR is not achieved before transplantation after treatment with or without extramedullary lesion invasion; 4) plan to undergo autologous hematopoietic stem cell transplantation; 5) recieve autologous hematopoietic stem cell transplantation within 12 months; 6) CD34 positive cell counts ≥2×106/kg; 7) The function of major organs is normal, and the laboratory test results meet the following criteria: a. Alanine aminotransferase (ALT) ≤3.0× upper limit of normal (ULN) aspartate aminotransferase (AST) ≤3.0×ULN; b. Serum total bilirubin ≤ 1.5×ULN; 8) Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent forms

Exclusion criteria

  • 1) Do not have indications for autologous hematopoietic stem cell transplantation; 2) presence of uncontrolled active infection (HIV-positive, positive for HBV-DNA and HCV-RNA quantitative tests); 3) severe respiratory diseases; 4) Severe abnormal liver function; 5) a second transplant is required; 6) Clinically significant or uncontrolled heart disease (grade III or IV congestive heart failure, EF<45%, BNP>5000ng/ml, TnT>0.06ug/L, oxygen saturation <95%, any of which) 7) Patients with other solid tumors; 8) Those who are allergic to setepa and the drug involved in the study or have a more serious allergic constitution; 9) Those who participate in other clinical research at the same time; 10) Other conditions judged by the investigator to be unsuitable for inclusion in this study.

Treatment and study plan

Thiotepa and Melphalan

Other

thiotepa and melphalan conditioning

melphalan

Other

melphalan conditioning

Primary outcomes

  1. relapse rate

    Time frame: one year after autologous stem cell transplantation

    relapse rate at one year after ASCT

Secondary outcomes

  1. hematopoietic recovery time

    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

  2. sCR rate

    Time frame: one month after ASCT

    strict complete remission rate

  3. OS

    Time frame: time from diagnosis to the end of follow-up or death which comes first

    overall survival

  4. PFS

    Time frame: time after ASCT to the end of follow-up or disease relapse which comes first

    progress free survival

  5. NRM

    Time frame: rate of death without disease relapse

    non relapse mortality

  6. Adverse events

    Time frame: within one month after ASCT

    Adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

ruimin liu

CONTACT

[email protected]

18706705664

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.