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 type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 58 (estimated) |
| Sponsor | Zhongnan Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | June 14, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 1, 2023 |
| Trial ID | NCT05970198 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
- Study coordinator: Fuling Zhou
- Email: zhoufuling@whu.edu.cn
- Phone: +86-02767813137
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.