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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Pegfilgrastim: Day 6: 6mg

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

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

G-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.

Study 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

Primary outcome measure(s)

• % 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

Trial sites (16)

More The Affiliated People's Hospital of Ningbo University trials in China

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