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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Treatments: Cyclophosphamide; Etoposide

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.