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

The Affiliated People's Hospital of Ningbo University

Status and phase: Enrolling; Phase 3

Conditions: Multiple Myeloma; Hematopoietic Stem Cell Mobilization

Treatments: Drug: G-CSF; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Pegfilgrastim; Drug: Cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT06520176

2024-060

Details and patient eligibility

About

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.

Full description

According to strict inclusion and exclusion criteria, 99 newly diagnosed MM patients will be selected. They will be randomly assigned in a 2:1 ratio to the EAP group or the CG group. During the hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells >5×10^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells >2×10^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.

Enrollment: 99 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

EAP regimen group

Experimental group

Description:

66 subjects will be enrolled into the EAP regimen group. EAP regimen is the combination of etoposide, cytarabine and PEG-rhG-CSF.

Treatment:

Drug: Pegfilgrastim

Drug: Cytarabine

Drug: Etoposide

Drug: G-CSF

Drug: G-CSF

CG regimen group

Active Comparator group

Description:

33 subjects will be enrolled into the CG regimen group. CG regimen is the combination of cyclophosphamide and G-CSF.

Treatment:

Drug: Cyclophosphamide

Drug: G-CSF

Drug: G-CSF