Comparing two regimens for mobilizing stem cells in multiple myeloma patients
A Prospective, Multicenter, Randomized Controlled Study of Etoposide, Cytarabine Combined With Pegfilgrastim vs. Cyclophosphamide Combined With G-CSF for Hematopoietic Stem Cell Mobilization in Newly Diagnosed Multiple Myeloma Patients
This study is testing whether a new combination of medications can help newly diagnosed multiple myeloma patients collect enough stem cells more effectively than a standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 99 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated People's Hospital of Ningbo University Government |
| Drugs / interventions | cyclophosphamide |
| Locations | 16 sites (Dongyang, Zhejiang and 15 other locations) |
| Trial ID | NCT06520176 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized, multicenter study evaluates the efficacy and safety of a combination regimen of etoposide, cytarabine, and Pegfilgrastim (EAP) against a control regimen of cyclophosphamide and G-CSF (CG) for mobilizing hematopoietic stem cells in newly diagnosed multiple myeloma patients. A total of 99 patients will be enrolled and randomly assigned to either the EAP or CG group. The study will compare the effectiveness of stem cell collection and monitor adverse reactions associated with both regimens. Key outcomes include the proportion of patients achieving target stem cell collection values and the cumulative collection of CD34 cells.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplantation.
Not a fit: Patients with significant cardiac issues, liver dysfunction, or those who have previously undergone stem cell mobilization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the efficiency of stem cell mobilization in multiple myeloma patients, potentially leading to better treatment outcomes.
How similar studies have performed: Other studies have shown promise in using similar regimens for stem cell mobilization, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients newly diagnosed as multiple myeloma. * 2\. Indication for ASCT. * 3\. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1. * 4\. Life expectancy ≥ 3 months. * 5\. Subjects must be able to understand the protocol and sign the informed consent. Exclusion Criteria: * 1\. Cardiac function class II or higher or cardiac ejection fraction \<40%. * 2\. Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN). * 3\. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN. * 4\. Serum creatinine clearance rate≤30%. * 5\. Patients with active infection. * 6\. Previously received hematopoietic stem cell mobilization.
Where this trial is running
Dongyang, Zhejiang and 15 other locations
- Dongyang People's Hospital — Dongyang, Zhejiang, China (Recruiting)
- The First Affiliated Hospital, College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- Tongde Hospital of Zhejiang Province — Hangzhou, Zhejiang, China (Recruiting)
- Huzhou central hospital — Huzhou, Zhejiang, China (Recruiting)
- The First Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)
- Jinhua Municipal Central Hospital — Jinhua, Zhejiang, China (Recruiting)
- Jinhua People's Hospital — Jinhua, Zhejiang, China (Recruiting)
- Lishui Central Hospital — Lishui, Zhejiang, China (Recruiting)
- Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)
- The Affiliated People's Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
- Shaoxing People's Hospital — Shaoxing, Zhejiang, China (Recruiting)
- Shaoxing Second Hospital — Shaoxing, Zhejiang, China (Recruiting)
- Taizhou Central Hospital — Taizhou, Zhejiang, China (Recruiting)
- Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
- The Second Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Ying Lu — The Affiliated People's Hospital of Ningbo University
- Study coordinator: Ying Lu
- Email: 814871416@qq.com
- Phone: +86-13486090834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.