Helical Tomotherapy in Multiple Myeloma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Autologous hematopoietic stem cell transplantation Porting method melphalan: recommended dose of 70 mg/m2/day with 2 consecutive days (days -2 and -1) intravenous (IV) for more than 30 minutes each prior to autologous hematopoietic stem cell transplantation (ASCT, day 0). |
Procedure: Autologous hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation;Porting method melphalan
|
| Experimental: Radiotherapy combined with autologous hematopoietic stem cell transplantation 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.Porting method melphalan. |
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
|
Outcome Measures
Primary Outcome Measures
- 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
- 1-year Progression-free Survival rate [1 year]
1-year Progression-free Survival rate
Other Outcome Measures
- 1-year Overall Survival rate [1 year]
1-year Overall Survival rate
- Platelet implantation time [3 months]
Platelet implantation time
- Neutrophil implantation time [3 months]
Neutrophil implantation time
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
-
Should agree to comply with all contraceptive requirements; 3, ECOG≤2;
-
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:
-
According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
-
Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
-
patients with uncontrolled or severe cardiovascular disease
-
According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China | 430071 |
Sponsors and Collaborators
- Fuling Zhou
Investigators
- Study Director: Fuling Zhou, Wuhan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 08