Helical Tomotherapy in Multiple Myeloma

NCT05970198 | Recruiting

• 1 other identifier: 08
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 1-year Progression-free Survival rate

  1 year

Other Outcomes (3)

• 1-year Overall Survival rate

  1 year

• Platelet implantation time

  3 months

• Neutrophil implantation time

  3 months

Study Arms (2)

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).

Procedure: Autologous hematopoietic stem cell transplantation

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.

Radiation: Total Marrow irradiation，TMI; Procedure: Autologous hematopoietic stem cell transplantation

Interventions

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.

Radiotherapy combined with autologous hematopoietic stem cell transplantation

Autologous hematopoietic stem cell transplantation PROCEDURE

Autologous hematopoietic stem cell transplantation;Porting method melphalan

Autologous hematopoietic stem cell transplantation; Radiotherapy combined with autologous hematopoietic stem cell transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fuling Zhou: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Fuling Zhou

  Wuhan University

  STUDY DIRECTOR

Central Study Contacts

Fuling Zhou

CONTACT

+86-02767813137; zhoufuling@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 1, 2023
• Study Start: June 14, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)