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Efficacy and safety of PEGylated recombinant human granulocyte stimulating factor in hematopoietic reconstruction after autologous hematopoietic stem cell transplantation in patients with multiple myeloma

Efficacy and safety of PEGylated recombinant human granulocyte stimulating factor in hematopoietic reconstruction after autologous hematopoietic stem cell transplantation in patients with multiple myeloma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082510
Enrollment
Unknown
Registered
2024-03-30
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple myeloma

Interventions

Experiment group:On the first day after transplantation, PEG-rhG-CSF was given 100 µg/kg subcutaneous injection once.

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Active MM in accordance with the criteria of the Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma (Revised 2022). Patients with multiple myeloma who were older than 18 years, had a physical fitness score of 2 or less, and received auto-HSCT between January 2024 and January 2027. The number of CD34 stem cells required for transplantation was 2×10^6 cells /kg.

Exclusion criteria

Exclusion criteria: Patients with other hematologic malignancies.

Design outcomes

Primary

MeasureTime frame
Neutrophil implantation time;6 months post-migration OS rate;hospitalization costs;

Secondary

MeasureTime frame
Grade 3 /4 granulocyte deficiency duration;Incidence of infection;Platelet implantation time;Platelet transfusion volume;Incidence of grade IV anemia;Adverse reaction;PFS rate at 6 months after transplantation.;

Countries

China

Contacts

Public ContactLiu tingting

Affiliated Hospital of Jiangnan University

liutingting0823@163.com+86 138 6171 8176

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026