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Trial Title:
Helical Tomotherapy in Multiple Myeloma
NCT ID:
NCT05970198
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Radiation
Intervention name:
Total Marrow irradiation，TMI
Description:
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.
Arm group label:
Radiotherapy combined with autologous hematopoietic stem cell transplantation
Intervention type:
Procedure
Intervention name:
Autologous hematopoietic stem cell transplantation
Description:
Autologous hematopoietic stem cell transplantation;Porting method melphalan
Arm group label:
Autologous hematopoietic stem cell transplantation
Arm group label:
Radiotherapy combined with autologous hematopoietic stem cell transplantation
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Fuling, director
Phone:
+86-02767813137
Email:
zhoufuling@163.com
Start date:
June 14, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Fuling Zhou
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05970198
