NCT07018271

A Study on the Use of Sulpegfilgrastim to Prevent the Incidence of Neutropenia With Infection in Newly Diagnosed Non-transplant Multiple Myeloma Patients

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to observe and evaluate the incidence of infection in newly diagnosed, non-transplanted multiple myeloma patients receiving prophylactic treatment with sulpegfilgrastim (a pegylated recombinant human granulocyte colony-stimulating factor).

Detailed description

It is a study on the use of sulpegfilgrastim to prevent the incidence of neutropenia with infection in newly diagnosed non-transplant multiple myeloma patients. Patients enrolled in this study may be treated with the following oncological protocols:DRD regimen (CD38 monoclonal antibody + lenalidomide + dexamethasone).On Day 1 of each oncological treatment cycle, after administration of the CD38 monoclonal antibody, a subcutaneous injection of Sulfubrolipoyl G-CSF will be given. The recommended fixed dose of Sulfubrolipoyl G-CSF is 6 mg per injection. The study will observe six treatment cycles. After the study concludes, the next treatment steps will be jointly decided by the investigator and the patient. If a patient's neutrophil level remains below 0.5×10⁹/L for over 24 hours after receiving Sulfubrolipoyl G-CSF, the investigator will assess the need for rescue treatment with short-acting G-CSF based on the patient's condition until the neutrophil level returns to normal.Prophylactic antibiotic treatment may be administered before the onset of oncological treatment. The goal is to observe and evaluate the incidence of infection in newly diagnosed, non-transplanted multiple myeloma patients receiving prophylactic treatment with sulpegfilgrastim (a pegylated recombinant human granulocyte colony-stimulating factor).

Conditions

• Multiple Myeloma
• DRD
• Sulpegfilgrastim
• Neutropenia

Interventions

Type	Name	Description
DRUG	sulpegfilgrastim	On Day 1 of each oncological treatment cycle, after administration of the CD38 monoclonal antibody, a subcutaneous injection of Sulfubrolipoyl G-CSF will be given. The recommended fixed dose of Sulfubrolipoyl G-CSF is 6 mg per injection.

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-06-30
• Completion: 2026-12-30
• First posted: 2025-06-12
• Last updated: 2025-06-12