Comparative study of stem cell mobilization methods using etoposide plus G-CSF vs G-CSF only

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0006245
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

We conducted a prospective trial comparing single-dose etoposide (375 mg/m2 for one day) plus G-CSF versus G-CSF alone, followed by risk-adapted plerixafor in myeloma patients. Despite significantly less frequent (p = 0.045) use of plerixafor in the etoposide group, the optimal collection rates (CD34+ cells = 6 × 106/kg) were not significantly different between the two groups (p = 0.195). In addition, the rate of collected CD34+ cells of = 8.0 × 106/kg was significantly higher in the etoposide group. Our results suggest that single-dose etoposide plus G-CSF may be a better option for patients who are expected to receive two or more transplantations.

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-05-31
• Results First Posted: 2023-09-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

a. Autologous stem cell transplantation-eligible multiple myeloma patients aged from 19 to 69
b. Patients with Eastern Cooperative Oncology Group performance status 0 to 2
c. Patients who achevied partial response more better after induction chemotherapy, including proteasome inhibitors (bortezomib or carfilzomib) and/or immunomodulatory durgs (thalidomide or lenalidomide)
d. Patients with adequate hematologic (neutrophil , hepatic and renal function
e. Patients (female) of childbearing potential must use a method of medically reliable birth control, with neative result of serum and/or urine ß–HCG

Exclusion Criteria

a. Patients who are willing to receive autologous stem cell transplantation in a salvage setting
b. Patients with previous history of autologous and/or allogeneic stem cell transplantation
c. Patients with primary amyloidosis, POEMS syndrome or Waldenström's macroglobulinemia
d. Patients with previous history hypersenstivity to etopoisde, G-CSF, or plerixafor

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optimal collection rate

Secondary Outcome Measures

Name	Time	Method
Adequate collection rate;Collection failure rate;Neutrophil engraftment incidence;Platelet engraftment incidence;Adverse events