Helical Tomotherapy in Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total Marrow irradiation，TMI, Autologous hematopoietic stem cell transplantation.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
Overview
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
- 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 - Procedure Autologous hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation;Porting method melphalan
Primary outcome measures
- Complete response rate and above 100 days after transplantation (≥ CR rate) [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (1)
- 1-year Progression-free Survival rate [Time frame: 1 year]
Eligibility 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;
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:
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongnan Hospital of Wuhan University — Wuhan
Identifiers
NCT: NCT05970198 · 08