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

NCT07542418 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2024LSYY-435
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma

Keywords

autologous stem cell transplantation; thiotepa; melphalan; conditioning

Outcome Measures

Primary Outcomes (1)

• relapse rate

  relapse rate at one year after ASCT

  one year after autologous stem cell transplantation

Secondary Outcomes (6)

• hematopoietic recovery time

  the first day of neutrophil more than 0.5X 10*9/L and Platelet more than 20X 10*9/L without transfusion after ASCT

• sCR rate

  one month after ASCT

• OS

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

• PFS

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

• NRM

  rate of death without disease relapse

Study Arms (2)

Experimental group

EXPERIMENTAL

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: Thiotepa and Melphalan

Control group

OTHER

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

Other: Melphalan

Interventions

Thiotepa and Melphalan OTHER

thiotepa and melphalan conditioning

Experimental group

Melphalan OTHER

melphalan conditioning

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thiotepa; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

ruimin liu

CONTACT

18706705664; xueyekexueshuzhuli@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 20, 2028
• Study Completion (Estimated): October 20, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04