Clinical trial Recruiting at 1 site Interventional Ages 18 to 75

Using Helical Tomotherapy for Multiple Myeloma Treatment

Official title: A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma

Run by Zhongnan Hospital · NCT05970198 · Data updated 2026-11-12

This study is testing if a combination of total body radiation and a chemotherapy drug can make stem cell transplants safer and more effective for people with multiple myeloma.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment58 (estimated)
SponsorZhongnan Hospital
Academic / other
Locations1 site (Wuhan, Hubei)
StatusRecruiting
StartedJune 14, 2023
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedAugust 1, 2023
Trial IDNCT05970198 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are multiple myeloma patients preparing for autologous stem cell transplantation who meet specific health criteria.

Probably not a fit

Patients who cannot tolerate melphalan and radiotherapy or have active viral infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of total body irradiation (TBI) combined with melphalan as a pretreatment for autologous hematopoietic stem cell transplantation in patients with multiple myeloma. It is a single-center, prospective study that enrolls myeloma patients who are undergoing induction therapy and preparing for stem cell mobilization. Participants will receive the specified treatment regimen and will be monitored for outcomes related to safety and effectiveness.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with multiple myeloma undergoing stem cell transplantation.

How similar studies have gone: While this approach is being explored in this trial, similar studies have shown promise in the use of radiotherapy combined with chemotherapy for hematological malignancies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
2. Should agree to comply with all contraceptive requirements; 3, ECOG≤2;

4\. Total bilirubin, ALT and AST \<2×UNL (upper limit of normal), BUN \< 30 mg/dL; 5. At least 2 x 10\^6 CD34+ cells /kg were collected; 6.absolute neutrophil count \>1000/uL and a platelet count of \>100,000/uL; 7. The expected survival time is more than 3 months; 8. Written informed consent was obtained from the patients or their immediate family members.

Exclusion Criteria:

Any of the following was an exclusion criterion:

1. According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
2. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
3. patients with uncontrolled or severe cardiovascular disease
4. According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness

Where it's running

  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.