Helical Tomotherapy in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970198
• Other study ID #: 08
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2023
• Source: Zhongnan Hospital
• Contact: Fuling Zhou
• Phone: +86-02767813137
• Email: zhoufuling[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Radiation:
• Total Marrow irradiation,TMI
TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given. TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.

Procedure:
• Autologous hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation;Porting method melphalan

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Fuling Zhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	1-year Overall Survival rate	1-year Overall Survival rate	1 year
Other	Platelet implantation time	Platelet implantation time	3 months
Other	Neutrophil implantation time	Neutrophil implantation time	3 months
Primary	Complete response rate and above 100 days after transplantation (= CR rate)	Complete response rate and above 100 days after transplantation (= CR rate)	through study completion, an average of 1 year
Secondary	1-year Progression-free Survival rate	1-year Progression-free Survival rate	1 year