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NCT Number: NCT05970198

Helical Tomotherapy in Multiple Myeloma

To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location status: Recruiting

Location contact

Zhou Fuling, director

CONTACT

[email protected]

+86-02767813137

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • 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

Treatment and study plan

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.

autologous hematopoietic stem cell transplantation

Procedure

Autologous hematopoietic stem cell transplantation;Porting method melphalan

Primary outcomes

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

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

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

Secondary outcomes

  1. 1-year Progression-free Survival rate

    Time frame: 1 year

    1-year Progression-free Survival rate

Other outcomes

  1. 1-year Overall Survival rate

    Time frame: 1 year

    1-year Overall Survival rate

  2. Platelet implantation time

    Time frame: 3 months

    Platelet implantation time

  3. Neutrophil implantation time

    Time frame: 3 months

    Neutrophil implantation time

Study contacts

Contact information is provided by the study sponsor or research team.

Fuling Zhou

CONTACT

[email protected]

+86-02767813137

Sponsors and collaborators

Lead sponsor

Fuling Zhou

Other

Registry information

Official study title

A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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