Clinical trial · Interventional
Helical Tomotherapy in Multiple Myeloma
A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
NCT05970198CI-TRIAL-00068394recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| Total Marrow irradiation，TMI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Autologous hematopoietic stem cell transplantation
- description
- 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).
- interventionNames
- Procedure: Autologous hematopoietic stem cell transplantation
- type
- EXPERIMENTAL
- label
- Radiotherapy combined with autologous hematopoietic stem cell transplantation
- 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.Porting method melphalan.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.