Helical Tomotherapy in Multiple Myeloma

Fuling Zhou58 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Multiple Myeloma

Interventions

Total Marrow irradiation，TMIRADIATION

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.

Autologous hematopoietic stem cell transplantationPROCEDURE

Autologous hematopoietic stem cell transplantation;Porting method melphalan

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Complete response rate and above 100 days after transplantation (≥ CR rate)

Time frame: through study completion, an average of 1 year

Secondary Outcomes

1-year Progression-free Survival rate

Time frame: 1 year

Central Contacts

Fuling Zhou

CONTACT

+86-02767813137 zhoufuling@whu.edu.cn

Data from ClinicalTrials.gov

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