High-dose chemotherapy and G-CSF for stem cell mobilization in multiple myeloma patients

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

This study is testing whether a combination of high-dose chemotherapy and G-CSF can help move stem cells into the blood better than another type of chemotherapy for patients with multiple myeloma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 164 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05517213 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized study aims to compare the effectiveness and safety of high-dose etoposide combined with G-CSF against high-dose cyclophosphamide with G-CSF for mobilizing peripheral blood stem cells in patients with multiple myeloma. The study involves administering high-dose chemotherapy followed by G-CSF to stimulate stem cell mobilization, with careful monitoring of blood parameters and apheresis procedures. The goal is to enhance mobilization efficiency and reduce side effects, ultimately facilitating smoother transitions to autologous stem cell transplantation for eligible patients.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-70 with confirmed multiple myeloma who are suitable for autologous stem cell transplantation.

Not a fit: Patients with severe comorbidities or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the mobilization of stem cells, leading to better outcomes for patients undergoing transplantation.

How similar studies have performed: Previous studies have shown promising results with similar high-dose chemotherapy approaches for stem cell mobilization, indicating potential for success.

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.

Where this trial is running

Beijing, Beijing

• Hospital 307 — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: wenrong huang, Dr.

Conditions Multiple Myeloma