Helical Tomotherapy in Multiple Myeloma

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Total Marrow irradiation，TMI

Autologous hematopoietic stem cell transplantation

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; 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: 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

Sites / Locations

Zhongnan Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Autologous hematopoietic stem cell transplantation

Radiotherapy combined with autologous hematopoietic stem cell transplantation

Arm 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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

1-year Progression-free Survival rate

Full Information

NCT ID

NCT05970198

First Posted

July 12, 2023

Last Updated

July 24, 2023

Sponsor

Fuling Zhou

1. Study Identification

Unique Protocol Identification Number

NCT05970198

Brief Title

Helical Tomotherapy in Multiple Myeloma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 14, 2023 (Actual)

Primary Completion Date

December 31, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Fuling Zhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Autologous hematopoietic stem cell transplantation

Arm Type

Active Comparator

Arm 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).

Arm Title

Radiotherapy combined with autologous hematopoietic stem cell transplantation

Arm Type

Experimental

Arm 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.

Intervention Type

Radiation

Intervention Name(s)

Total Marrow irradiation，TMI

Intervention 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.

Intervention Type

Procedure

Intervention Name(s)

Autologous hematopoietic stem cell transplantation

Intervention Description

Autologous hematopoietic stem cell transplantation;Porting method melphalan

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

through study completion, an average of 1 year

Secondary Outcome Measure Information:

Title

1-year Progression-free Survival rate

Description

1-year Progression-free Survival rate

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

1-year Overall Survival rate

Description

1-year Overall Survival rate

Time Frame

1 year

Title

Platelet implantation time

Description

Platelet implantation time

Time Frame

3 months

Title

Neutrophil implantation time

Description

Neutrophil implantation time

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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; 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fuling Zhou

Phone

+86-02767813137

Email

zhoufuling@whu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fuling Zhou

Organizational Affiliation

Wuhan University

Official's Role

Study Director

Facility Information:

Facility Name

Zhongnan Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhou Fuling, director

Phone

+86-02767813137

Email

zhoufuling@163.com

12. IPD Sharing Statement

Plan to Share IPD

No

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial