Multiple Myeloma
Conditions
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.
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.
Interventions
RADIATIONTotal 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.
PROCEDUREAutologous hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation;Porting method melphalan
Sponsors
Fuling Zhou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 1-year Progression-free Survival rate | 1 year | 1-year Progression-free Survival rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactFuling Zhou
Outcome results
None listed