This is a multicenter prospective study to evaluate the efficacy and safety of chemotherapy combined with a single dose of subcutaneous(SC) injection mecapegfilgrastim on day 2 or day 5 after chemotherapy for autologous peripheral blood stem cell (PBSC) mobilization in patients with multiple myeloma or lymphoma.
Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to the protocol, high-dose cyclophosphamide (50mg/kg or 2g/m2, for 2 days) is given to patients with MM, and high-dose etoposide (1.5-1.8g/m2, single dose ) is administered to patients with lymphoma. Apheresis is performed according to the standard institutional regulations. The primary point is to evaluate the percentage of successful mobilization, defined as the cumulative collection of ≥2×10\^6/kg CD34+ cells in three or fewer apheresis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Etoposide 1.5-1.8g/m2, single dose
Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGPeking University Third Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
percentage of successful mobilization
The percentage of subjects with ≥2×106 cell/kg CD34+ cells were collected.
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
the number of the total CD34+ cells
the number of the total CD34+ cells which were collected from each subject
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
the number of leukaphereses
the number of leukaphereses needed to collect ≥2×10\^6/kg CD34+ cells
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
Incidence of febrile neutropenia (FN)
incidence of FN during chemotherapy plus mecapegfilgrastim mobilization
Time frame: up to 28 days since the last subject were given mecapegfilgrastim
times to neutrophil and platelet engraftment
times to neutrophil and platelet engraftment after autologous stem cell transplantation
Time frame: up to 1 year post-transplantation
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Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy
Shandong Cancer Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGInstitute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGTianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
NOT_YET_RECRUITING