Clinical trial · Interventional
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic 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
- 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 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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic Stem Cell Mobilization | — | UNRESOLVED | — |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EAP regimen group
- description
- 66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.
- interventionNames
- Drug: Etoposide
- Drug: Cytarabine
- Drug: Pegfilgrastim
- Drug: G-CSF
- type
- ACTIVE_COMPARATOR
- label
- CG regimen group
- description
- 33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.
- interventionNames
- Drug: Cyclophosphamide
- Drug: G-CSF
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available