Clinical trial NCT06520176: Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Hematopoietic Stem Cell Mobilization
Keywords: Multiple Myeloma
Etoposide
Cytarabine
PEG-rhG-CSF
Hematopoietic Stem Cell Mobilization
Lead sponsor: The Affiliated People's Hospital of Ningbo University
Sponsor class: OTHER_GOV
Collaborators: name: First Affiliated Hospital of Zhejiang University
name: First Affiliated Hospital of Wenzhou Medical University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: The Central Hospital of Lishui City
name: Jinhua People's Hospital
name: Shaoxing People's Hospital
name: Shaoxing Second Hospital
name: Zhejiang Provincial Tongde Hospital
name: Taizhou Hospital
name: Dongyang People's Hospital
name: Affiliated Hospital of Jiaxing University
name: Huizhou Municipal Central Hospital
name: Second Affiliated Hospital of Wenzhou Medical University
name: Ningbo Medical Center Lihuili Hospital
name: Jinhua Municipal Central Hospital
First posted: 2024-07-25
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, two-arm, multicenter, exploratory study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg
timeFrame: 1 month
Secondary outcomes:
measure: % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg
timeFrame: 1 month
measure: CD34+ cells and the average number of collections
timeFrame: 1 month
measure: Adverse Rvents (AEs)
timeFrame: 1 month
measure: % of patients who use Plerixafor
timeFrame: 1 month
Other outcomes:
Locations:
city: Dongyang
country: China
facility: Dongyang People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Tongde Hospital of Zhejiang Province
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou central hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First Hospital of Jiaxing
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Jinhua
country: China
facility: Jinhua People's Hospital
state: Zhejiang
city: Lishui
country: China
facility: Lishui Central Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Center Lihuili Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated People's Hospital of Ningbo University
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing People's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Second Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The Affiliated People's Hospital of Ningbo University
name: Ying Lu
role: PRINCIPAL_INVESTIGATOR
References: