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New drug duo aims to slash myeloma relapse after transplant

NCT ID NCT07542418

Disease control Sponsor: First Affiliated Hospital Xi'an Jiaotong University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding thiotepa to the standard melphalan treatment before a stem cell transplant can lower the chance of multiple myeloma coming back within a year. It includes 204 adults aged 18-70 whose cancer was not fully cleared by prior therapy. Participants are randomly assigned to get either the new two-drug combo or melphalan alone, then receive their own stem cells and are followed for one year.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 204 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.