Multiple MyelomaNCT07542418
Study of Thiotepa Combination With Melphalan (TM Protocol) Conditioning for Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma：A Prospective Randomized Controlled Clinical Trial
A study testing Thiotepa and Melphalan and Melphalan in people with Multiple Myeloma, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thiotepa and Melphalan and Melphalan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 20 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Thiotepa and Melphalan, Melphalan
- Keywords
- autologous stem cell transplantation, thiotepa, melphalan, conditioning
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiotepa and MelphalanOther
thiotepa and melphalan conditioning
MelphalanOther
melphalan conditioning
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse rate
relapse rate at one year after ASCT
Measured: one year after autologous stem cell transplantation
Secondary outcomes (6)
hematopoietic recovery time
the time of recovery of neutrophil and platelet
Measured: 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
strict complete remission rate
Measured: one month after ASCT
OS
overall survival
Measured: time from diagnosis to the end of follow-up or death which comes first
PFS
progress free survival
Measured: time after ASCT to the end of follow-up or disease relapse which comes first
NRM
non relapse mortality
Measured: rate of death without disease relapse
Adverse events
Adverse events
Measured: within one month after ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Apr 2028 (estimated)
- Study completion20 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542418
- Sponsor's protocol ID
- XJTU1AF2024LSYY-435
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Thiotepa Combination With Melphalan (TM Protocol) Conditioning for Autologous Hematopoietic Stem Cell Transplantation in Multiple Myeloma：A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07542418
- Acronym / sponsor ID
- XJTU1AF2024LSYY-435
- Conditions
- Multiple Myeloma
- Keywords
- autologous stem cell transplantation, thiotepa, melphalan, conditioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Apr 2028 (estimated)
- Study completion
- 20 Oct 2028 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Thiotepa and Melphalantotal 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 |
| Control group | Other | Other: Melphalanmelphalan 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiotepa and Melphalanthiotepa and melphalan conditioning | Other | Experimental group |
| Melphalanmelphalan conditioning | Other | Control group |
Primary outcome
relapse rate
Time frame: one year after autologous stem cell transplantation
relapse rate at one year after ASCT
6 secondary outcomes
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
sCR rate
Time frame: one month after ASCT
OS
Time frame: time from diagnosis to the end of follow-up or death which comes first
PFS
Time frame: time after ASCT to the end of follow-up or disease relapse which comes first
NRM
Time frame: rate of death without disease relapse
Adverse events
Time frame: within one month after ASCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Thiotepa and Melphalan and Melphalan in people with Multiple Myeloma, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ruimin liu (18706705664, xueyekexueshuzhuli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapse rate (time frame: one year after autologous stem cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.