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

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.

• Etoposide (Drug), also known as VP-16: Day 1\~Day 2: 75mg/m\^2
• Cytarabine (Drug), also known as Ara-C: Day 1\~Day 2: 200g/m\^2, q12h
• Pegfilgrastim (Drug), also known as PEG-rhG-CSF: Day 6: 6mg
• Cyclophosphamide (Drug), also known as Cy: Day 1\~Day 2: 1～2g/m\^2
• G-CSF (Drug), also known as Granulocyte Colony Stimulating Factor: Subcutaneous injection at dose 5ug/kg, from day 6 until the end of mobilization.
• G-CSF (Drug), also known as Granulocyte Colony Stimulating Factor: 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.

Primary outcomes

• % of patients achieving the collection of ≥5×10^6 CD34+ cells/kg [1 month]: Proportion of patients who achieve the ideal collection value (CD34+ cells ≥5×10\^6/kg) after a single collection

Secondary outcomes

• % of patients achieving the collection of ≥2×10^6 CD34+ cells/kg [1 month]: 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.
• CD34+ cells and the average number of collections [1 month]: Comparison of the total amount of CD34+ cells collected and the average number of collections between the EAP and CG regimens.
• Adverse Rvents (AEs) [1 month]: Comparison of hematological and non-hematological adverse reactions between the EAP and CG regimens.
• % of patients who use Plerixafor [1 month]: Comparison of the proportion of patients who add Plerixafor between the EAP and CG regimens.

Sex: All, ages: 18 Years to 75 Years

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.

• Ying Lu, Principal investigator, The Affiliated People's Hospital of Ningbo University