Using Helical Tomotherapy for Multiple Myeloma Treatment
A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
NA · Zhongnan Hospital · NCT05970198
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zhongnan Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05970198 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are multiple myeloma patients preparing for autologous stem cell transplantation who meet specific health criteria.
Not a fit: Patients who cannot tolerate melphalan and radiotherapy or have active viral infections may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Wuhan, Hubei
- Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Fuling Zhou
- Email: zhoufuling@whu.edu.cn
- Phone: +86-02767813137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Myeloma