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To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation | Active Comparator | 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). |
|
| Radiotherapy combined with autologous hematopoietic stem cell transplantation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Marrow irradiation，TMI | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate and above 100 days after transplantation (≥ CR rate) | Complete response rate and above 100 days after transplantation (≥ CR rate) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Progression-free Survival rate | 1-year Progression-free Survival rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Overall Survival rate | 1-year Overall Survival rate | 1 year |
| Platelet implantation time | Platelet implantation time | 3 months |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuling Zhou | Contact | +86-02767813137 | zhoufuling@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fuling Zhou | Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| Autologous hematopoietic stem cell transplantation | Procedure | Autologous hematopoietic stem cell transplantation;Porting method melphalan |
|
| Neutrophil implantation time | Neutrophil implantation time | 3 months |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |