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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Institute of Hematology & Blood Diseases Hospital
RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Tianjin Medical University General Hospital
NOT_YET_RECRUITING
Tianjin
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Wei Liu
liuwei@ihcams.ac.cn
86-022-23909282
Time Frame
Start Date: 2022-04-26
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 120
Treatments
Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 2
Experimental: lymphoma, chemotherapy plus Mecapegfilgrastim SC on day 5
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 2
Experimental: myltiple myeloma, chemotherapy plus Mecapegfilgrastim SC on day 5
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov

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