drugset / Trial / NCT06520176
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
Phase 3
Recruiting
99 enrolled
The Affiliated People's Hospital of Ningbo University
Affiliated Hospital of Jiaxing University · collabDongyang People's Hospital · collabFirst Affiliated Hospital of Wenzhou Medical University · collabFirst Affiliated Hospital of Zhejiang University · collabHuizhou Municipal Central Hospital · collabJinhua Municipal Central Hospital · collabJinhua People's Hospital · collabNingbo Medical Center Lihuili Hospital · collabSecond Affiliated Hospital of Wenzhou Medical University · collabShaoxing People's Hospital · collabShaoxing Second Hospital · collabTaizhou Hospital · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collabThe Central Hospital of Lishui City · collabZhejiang Provincial Tongde Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). A total of 99 NDMM patients will be enrolled and randomly assigned to receive either the EAP regimen or the GC regimen (cyclophosphamide+ G-CSF) to mobilize hematopoietic stem cells. Subsequently, the mobilization effects and adverse reactions of all patients will be observed and compared.
Timeline
- Start
- 2024-08
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 1 g | — |
| Comparator | Cyclophosphamide | Other / unclassified | 2 g | — |
| Subject | Cytarabine | Small molecule | 200 unknown | — |
| Subject | Etoposide | Small molecule | 75 mg/m2 | — |
| Subject | G-CSF | Unknown | 5 ug/kg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |