Status:
RECRUITING
Helical Tomotherapy in Multiple Myeloma
Lead Sponsor:
Fuling Zhou
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
Detailed Description
This study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel regimen for transplan...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Any of the following was an exclusion criterion:
- According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
- 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
Key Trial Info
Start Date :
June 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05970198
Start Date
June 14 2023
End Date
December 31 2027
Last Update
August 1 2023
Active Locations (1)
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1
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071