NCT05970198Recruiting
Helical Tomotherapy in Multiple Myeloma
A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 1 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- 14 Jun 2023
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fuling Zhou
- Diseases
- Multiple myeloma
- NCT number
- NCT05970198
What you commit to
- Study type: Interventional
- Planned participants: 58
- From 14 Jun 2023 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
Other illness
- Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
- patients with uncontrolled or severe cardiovascular disease
- According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
Other
- Any of the following was an exclusion criterion:
Who the study is looking for
- Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.