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

A comparative randomized prospective trial, comparing the efficacy and safety between etoposide plus G-CSF and G-CSF only, followed by peripheral blood CD34+ cell count-adapted plerixafor mobilization for autologous transplantation–eligible patients with multiple myeloma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0006245

Enrollment

Registered

2021-06-11

Start date

2021-06-01

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : a. Etoposide + G-CSF ± Plerixafor arm (1) Administer Etoposide 375 mg/m² i.v on day 1, then Neutrogin® 10 µg/kg (maximum 750 µg) s.c on day 9-12 (2) Check PB CD34+ cell count at the morni

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Optimal collection rate	—

Secondary

Measure	Time frame
Adequate collection rate;Collection failure rate;Neutrophil engraftment incidence;Platelet engraftment incidence;Adverse events	—

Countries

Korea, Republic of

Contacts

Public ContactSeung-Hwan Shin

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

shin.seunghwan@kakao.com+82-2-2030-2647

Outcome results