None listed
Conditions
Interventions
Drug : Enrolled patients received etoposide (375 mg/m2 IV for one day) followed nine days later by G-CSF (10 µg/kg SC) until the last day of apheresis. If the PB CD34+ cell count measured on the morni
Sponsors
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 19 years or older with histologically confirmed MM intended for ASCT. (2) Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. (3) Patients who have achieved a partial response or better according to the IMWG Uniform Response Criteria after at least three cycles of daratumumab and/or lenalidomide-containing induction therapy. (4) Patients with adequate hematologic function (neutrophil count = 1000/mm³ and platelet count = 75,000/mm³), hepatic function (total bilirubin and aspartate and alanine aminotransferase levels = 2.5 times the upper limit of normal), cardiac function (ejection fraction = 30%), and renal function (creatinine clearance = 30 mL/min/1.73 m² as calculated by the Cockcroft-Gault formula). (5) For women of childbearing potential, a negative urine (or serum) ß-HCG result and agreement to use a medically acceptable method of contraception during the clinical trial period.
Exclusion criteria
Exclusion criteria: (1) Patients intended to receive ASCT as salvage therapy for disease progression following prior therapy. (2) Patients diagnosed with plasma cell disorders other than multiple myeloma (such as amyloidosis without multiple myeloma, POEMS syndrome, or Waldenström’s macroglobulinemia). (3) Patients with a history of hypersensitivity to any of the agents used in this clinical trial, including etoposide, G-CSF, or plerixafor. (4) Patients with a history of autologous or allogeneic SCT for other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal collection rate (the proportion of patients with CD34+ cells collected at 8×106/kg or greater by apheresis for a maximum of three days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adequate collection rate (the proportion of patients with CD34+ cells collected at 4×106/kg or greater by apheresis for a maximum of three days);Collection failure rate (proportion of patients with less than 2×106/kg of CD34+ cells collected by apheresis for a maximum of three days);Incidence of adverse events (The incidence of adverse events from etoposide administration to 48 hours after the completion of aphresis);Neutrophil engraftment incidence;Platelet engraftment incidence | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Eun Park
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Outcome results
None listed