Health TrialsbyHealthPanel

Helical Tomotherapy in Multiple Myeloma

ConditionMultiple Myeloma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFuling Zhou

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    Autologous hematopoietic stem cell transplantation;Porting method melphalan

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Autologous hematopoietic stem cell transplantationActive comparator 1 intervention
Group B: Radiotherapy combined with autologous hematopoietic stem cell transplantationExperimental treatment 2 interventions

Trial outcomes

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)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

1-year Progression-free Survival rate

1-year Progression-free Survival rate

Time frame
1 year

Other outcomes

1

1-year Overall Survival rate

1-year Overall Survival rate

Time frame
1 year
2

Platelet implantation time

Platelet implantation time

Time frame
3 months
3

Neutrophil implantation time

Neutrophil implantation time

Time frame
3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fuling Zhou

Lead sponsor

Zhongnan Hospital

Sponsor institution

Source ClinicalTrials.gov
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