A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma
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.
• Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
• Patients who had achieved at least partial response (PR);
• Patients who were eligible for autologous peripheral blood stem cell transplantation
• Age≥18 and≤65 years;
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients who have an estimated life expectancy of more than three months
• Fertile patients must be willing to use reliable contraception during the clinical study period and for 90 days after the last dose and have a negative serological pregnancy test within 72 hours prior to the first dose.
• Patients must be able and willing to give written informed consent prior to any study-related procedures