NCT05294055

Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Multiple Myeloma
• Lymphoma

Interventions

Type	Name	Description
DRUG	Etoposide	Etoposide 1.5-1.8g/m2, single dose
DRUG	Cyclophosphamide	Cyclophosphamide 50mg/kg or 2g/m2, for 2 days
DRUG	Mecapegfilgrastim, day 2	Mecapegfilgrastim 12mg SC, on day 2 after chemotherapy
DRUG	Mecapegfilgrastim, day 5	Mecapegfilgrastim 12mg SC, on day 5 after chemotherapy

Timeline

• Start date: 2022-04-26
• Primary completion: 2026-03-31
• Completion: 2026-09-30
• First posted: 2022-03-24
• Last updated: 2025-05-13

Locations

7 sites across 1 country: China