NCT05970198

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Fuling Zhou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-14
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-08-01
• Last updated: 2023-08-01

Locations

1 site across 1 country: China