Helical Tomotherapy in Multiple Myeloma

Not Applicable

Recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT05970198
• Lead Sponsor: Fuling Zhou

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 transplant pretreatment. Subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.

Study Timeline

• Study Start: 2023-06-14
• Status Verified: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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;

3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complete response rate and above 100 days after transplantation (≥ CR rate)	through study completion, an average of 1 year	Complete response rate and above 100 days after transplantation (≥ CR rate)

Secondary Outcome Measures

Name	Time	Method
1-year Progression-free Survival rate	1 year	1-year Progression-free Survival rate

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China