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

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

NCT ID: NCT05517213

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Cyclophosphamide
Etoposide

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention 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

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Etoposide
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.
Arm group label: Etoposide

Other name: VP-16

Intervention type: Drug
Intervention name: Cyclophosphamide
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.
Arm group label: Cyclophosphamide

Other name: CTX

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Hospital 307

Address:
City: Beijing
Zip: 100071
Country: China

Status: Recruiting

Contact:
Last name: Wenrong Huang, Dr.

Phone: 861066947169
Email: huangwr301@163.com

Contact backup:
Last name: Xiubin Xiao, Dr.

Phone: 861066947167
Email: xiaoxb2021@163.com

Start date: February 1, 2022

Completion date: October 1, 2025

Lead sponsor:
Agency: Affiliated Hospital to Academy of Military Medical Sciences
Agency class: Other

Source: Affiliated Hospital to Academy of Military Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05517213