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High-dose Chemotherapy+G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Etoposide

Cyclophosphamide

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Confirmed MM patients: patients who were initially diagnosed and treated, who were suitable for autologous transplantation and planned to be treated with ASCT;
- Age limitation: 18-70 years old patients; ④ Physical status: ECOG physical status score was 0 or 1; ⑤ The adverse reactions caused by chemotherapy had recovered: peripheral blood leukocytes ≥3.0×109/L, hemoglobin ≥80g/L, platelet ≥80×109/L; Liver function glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase ≤ 2 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value, serum creatinine ≤ 1.5 times the upper limit of normal value, chest CT normal, ecg normal; (5) Patients participate voluntarily and informed consent is signed by patients themselves (or their legal representatives); Take effective contraceptive measures during the childbearing age.

Exclusion Criteria:

① According to the clinical judgment of the researcher: According to NCI CTCAE (4th edition May 28, 2009), patients with ≥3 grade cardiopulmonary insufficiency and severe kidney disease, currently diagnosed as coronary heart disease, myocardial infarction, arrhythmia, glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase ≥ 2 times the upper limit of normal value, Total bilirubin ≥ 1.5 times the upper limit of normal;

With active infection, including fever of unknown cause (axillary temperature > 37.5℃); ③ Patients with severe history of mental system.

Sites / Locations

Hospital 307Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Etoposide

Cyclophosphamide

Arm Description

Etoposide1.2g/m2(Pump continuously for 24h)+G-CSF10ug/kg.

Cyclophosphamide 3.0g/m2+Grh-CSF10ug/kg.

Outcomes

Primary Outcome Measures

Main purpose

Compared with the literature data, The primary efficacy endpoint was the difference in the proportion of patients who reached the target CD34+ cells ≥5×106/kg and CD34+ cells ≥5×106/kg within 3 days of monotherapy between the study group and the control group.

Secondary Outcome Measures

Full Information

NCT ID

NCT05517213

First Posted

August 24, 2022

Last Updated

August 24, 2022

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05517213

Brief Title

High-dose Chemotherapy+G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma

Official Title

High-dose Etoposide +G-CSF Versus High-dose Cyclophosphamide +G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma：a Multicenter,Randomized,Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study was a multi-center, randomized, prospective study. The purpose is to clarify that high-dose VP-16+G-CSF has better mobilization efficiency and less toxic and side effects compared with high-dose CTX+G-CSF, and minimize mobilization failure, so as to provide convenient and high-quality mobilization programs for clinical practice and enable more patients to enter the transplantation stage smoothly.

Detailed Description

Autologous peripheral blood hematopoietic stem cell mobilization: the two regiments were VP-16 1.2g/m2+rhG-CSF 10ug·kg-1·d-1 and CTX 3.0g/m2+rhG-CSF 10ug·kg-1·d-1; After high-dose chemotherapy, RHG-CSF 5ug/kg Bid was injected subcutaneously until the end of stem cell collection when the white blood cell count decreased to the minimum and began to rise steadily, and the platelet count was ≥50×109/L. Vp-16 was used as pure liquid continuously pumped for 24h. Dexamethasone 10mg was given before use, and blood pressure was monitored during use. During the use of CTX, it should be hydrated and alkalized, and mesic sodium (total amount 1.0-1.2 times CTX, divided into three static drops) should be used. Apheresis was performed once a day from the 5th day of RHG-CSF application, and the circulating blood volume was 2-3 times of the blood volume each time, and apheresis was performed at most 3 times. The percentage of CD34+ cells in the collection was determined by FCM, and the volume of the collection, the total number of nucleated cells per kg body weight and the number of CD34+ cells were recorded. For some patients whose apheresis is not up to the standard, they can be mobilized again after 1 month of rest, and chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.

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

Crossover Assignment

Model Description

All patients were randomly assigned 1:1 to CTX 3.0g/m2+ G-CSF 10ug/kg or VP-16 1.2g/m2+G-CSF10ug/kg

Masking

None (Open Label)

Allocation

Randomized

Enrollment

164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Etoposide

Arm Type

Experimental

Arm Description

Etoposide1.2g/m2(Pump continuously for 24h)+G-CSF10ug/kg.

Arm Title

Cyclophosphamide

Arm Type

Experimental

Arm Description

Cyclophosphamide 3.0g/m2+Grh-CSF10ug/kg.

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

VP-16

Intervention Description

Chemotherapy combined with rhG-CSF is widely used in autologous hematopoietic stem cell mobilization programs. For patients who do not meet the criteria of stem cell collection, they can be mobilized again after 1 month of rest. Chemotherapy +rhG-CSF mobilization or rhG-CSF+ ploxafo steady-state mobilization can be used.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

CTX

Intervention Description

Primary Outcome Measure Information:

Title

Main purpose

Description

Time Frame

Enrollment is expected to last for one year, followed up for two years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed MM patients: patients who were initially diagnosed and treated, who were suitable for autologous transplantation and planned to be treated with ASCT; Age limitation: 18-70 years old patients; ④ Physical status: ECOG physical status score was 0 or 1; ⑤ The adverse reactions caused by chemotherapy had recovered: peripheral blood leukocytes ≥3.0×109/L, hemoglobin ≥80g/L, platelet ≥80×109/L; Liver function glutamic-pyruvic transaminase and glutamic-oxalacetic transaminase ≤ 2 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value, serum creatinine ≤ 1.5 times the upper limit of normal value, chest CT normal, ecg normal; (5) Patients participate voluntarily and informed consent is signed by patients themselves (or their legal representatives); Take effective contraceptive measures during the childbearing age. Exclusion Criteria: ① According to the clinical judgment of the researcher: According to NCI CTCAE (4th edition May 28, 2009), patients with ≥3 grade cardiopulmonary insufficiency and severe kidney disease, currently diagnosed as coronary heart disease, myocardial infarction, arrhythmia, glutamic-oxalacetic transaminase, glutamic-pyruvic transaminase ≥ 2 times the upper limit of normal value, Total bilirubin ≥ 1.5 times the upper limit of normal; With active infection, including fever of unknown cause (axillary temperature > 37.5℃); ③ Patients with severe history of mental system.

Central Contact Person:

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

wenrong huang, Dr.

Phone

861066947169

huangwr301@163.com

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

Xiubin Xiao, Dr.

Phone

861066947167

xiaoxb2021@163.com

Facility Information:

Facility Name

Hospital 307

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenrong Huang, Dr.

Phone

861066947169

huangwr301@163.com

First Name & Middle Initial & Last Name & Degree

Xiubin Xiao, Dr.

Phone

861066947167

xiaoxb2021@163.com

12. IPD Sharing Statement

Plan to Share IPD

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High-dose Chemotherapy+G-CSF in Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma

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