Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Location status: Recruiting
NCT Number: NCT05970198
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430071, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Any of the following was an exclusion criterion:
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.
Autologous hematopoietic stem cell transplantation;Porting method melphalan
Time frame: through study completion, an average of 1 year
Complete response rate and above 100 days after transplantation (≥ CR rate)
Time frame: 1 year
1-year Progression-free Survival rate
Time frame: 1 year
1-year Overall Survival rate
Time frame: 3 months
Platelet implantation time
Time frame: 3 months
Neutrophil implantation time
Contact information is provided by the study sponsor or research team.
Fuling Zhou
Other
A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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