NCT05517213

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Etoposide	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.
DRUG	Cyclophosphamide	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-08-26
• Last updated: 2025-10-02

Locations

1 site across 1 country: China