Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Etoposide
- description
- Etoposide1.2g/m2(Pump continuously for 24h)+G-CSF10ug/kg.
- interventionNames
- Drug: Etoposide
- type
- EXPERIMENTAL
- label
- Cyclophosphamide
- description
- Cyclophosphamide 3.0g/m2+Grh-CSF10ug/kg.
- interventionNames
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Main purpose
- timeFrame
- Enrollment is expected to last for one year, followed up for two years.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSun Y, Li J, Dong Y, Li M, Wang Y, Chen X, Yuan S, Lu Y, Ma Y, Chen J, Gao W, Huang W, Liu Y, Xiao X. A randomized comparison of etoposide and cyclophosphamide for stem cell mobilization in newly diagnosed multiple myeloma. Sci Rep. 2026 Apr 2;16(1):15790. doi: 10.1038/s41598-026-46787-1. PMID 41927700