RecruitingPhase 3NCT06520176

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


Sponsor

The Affiliated People's Hospital of Ningbo University

Enrollment

99 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two chemotherapy regimens (EAP versus CG) for collecting stem cells from the blood in people with newly diagnosed multiple myeloma who need a stem cell transplant. **You may be eligible if...** - You have been newly diagnosed with multiple myeloma - You need an autologous stem cell transplant (using your own stem cells) - You are in good general health (ECOG 0–1) with a life expectancy of at least 3 months - You have not had a previous stem cell collection **You may NOT be eligible if...** - You have heart failure or low heart pumping function (ejection fraction below 40%) - Your liver function is significantly impaired - Your kidney function is significantly reduced (creatinine clearance ≤30%) - You have an active infection - You have previously had a stem cell mobilization procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtoposide

Day 1\~Day 2: 75mg/m\^2

DRUGCytarabine

Day 1\~Day 2: 200g/m\^2, q12h

DRUGPegfilgrastim

Day 6: 6mg

DRUGCyclophosphamide

Day 1\~Day 2: 1~2g/m\^2

DRUGG-CSF

Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.

DRUGG-CSF

Starting from the 9th day, if the white blood cell count is less than 20,000/μL, administer G-CSF at a dose of 5μg/kg by subcutaneous injection until the collection is completed.


Locations(16)

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

View Full Details on ClinicalTrials.gov

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NCT06520176


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