Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
NCT Number: NCT06520176
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Multiple Myeloma|Hematopoietic Stem Cell Mobilization
Interventions: DRUG: Etoposide|DRUG: Cytarabine|DRUG: Pegfilgrastim|DRUG: Cyclophosphamide|DRUG: G-CSF|DRUG: G-CSF
Sponsor: The Affiliated People's Hospital of Ningbo University
Collaborators: First Affiliated Hospital of Zhejiang University|First Affiliated Hospital of Wenzhou Medical University|Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University|The Central Hospital of Lishui City|Jinhua People's Hospital|Shaoxing People's Hospital|Shaoxing Second Hospital|Zhejiang Provincial Tongde Hospital|Taizhou Hospital|Dongyang People's Hospital|Affiliated Hospital of Jiaxing University|Huizhou Municipal Central Hospital|Second Affiliated Hospital of Wenzhou Medical University|Ningbo Medical Center Lihuili Hospital|Jinhua Municipal Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 99
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-12
Locations: Dongyang People's Hospital, Dongyang, Zhejiang, China|The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China|Tongde Hospital of Zhejiang Province, Hangzhou, Zhejiang, China|Huzhou central hospital, Huzhou, Zhejiang, China|The First Hospital of Jiaxing, Jiaxing, Zhejiang, China|Jinhua Municipal Central Hospital, Jinhua, Zhejiang, China|Jinhua People's Hospital, Jinhua, Zhejiang, China|Lishui Central Hospital, Lishui, Zhejiang, China|Ningbo Medical Center Lihuili Hospital, Ningbo, Zhejiang, China|The Affiliated People's Hospital of Ningbo University, Ningbo, Zhejiang, China|Shaoxing People's Hospital, Shaoxing, Zhejiang, China|Shaoxing Second Hospital, Shaoxing, Zhejiang, China|Taizhou Central Hospital, Taizhou, Zhejiang, China|Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, China|The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China|The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

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.

Primary Outcome Measures: % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg, Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection, 1 month
Secondary Outcome Measures: % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg, Comparison of the cumulative proportion of patients who achieve the target collection value (CD34+ cells ≥2×10\^6/kg) between the EAP and CG regimens; the proportion of patients who achieve the ideal collection value., 1 month|CD34+ cells and the average number of collections, Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens., 1 month|Adverse Rvents (AEs), Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens., 1 month|% of patients who use Plerixafor, Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens., 1 month