Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients

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.

Eligibility

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.

Conditions3

Interventions5

Related trials

• A Phase 1 Study of ADI-001 in Rheumatoid Arthritis — Adicet Therapeutics
• A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL — TriArm Therapeutics (Taiwan) Limited
• A Phase I Clinical Study of IX001 TCR-T Injection in the Treatment of Advanced Pancreatic Cancer Patients With KRAS G12V Mutation — Sun Yat-sen University
• A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer — Shanghai JMT-Bio Inc.
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL — The First Affiliated Hospital of Zhengzhou University
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of Haplo-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL — The First Affiliated Hospital of Zhengzhou University
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Adult ALL — The First Affiliated Hospital of Zhengzhou University
• A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL — The First Affiliated Hospital of Zhengzhou University

Browse More Trials