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).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
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.
Incidence of infection during oncological treatment
Incidence of infection during oncological treatment
Time frame: through study completion, an average of 6 months
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN)
Time frame: through study completion, an average of 6 months
Incidence of infection in patients with ANC <1.0×10⁹/L
Incidence of infection in patients with ANC \<1.0×10⁹/L
Time frame: through study completion, an average of 6 months
Proportion of patients requiring dose adjustment due to ANC reduction or infection
Proportion of patients requiring dose adjustment due to ANC reduction or infection
Time frame: through study completion, an average of 6 months
Incidence of Grade 3 or higher ANC reduction in the first treatment cycle
Incidence of Grade 3 or higher ANC reduction in the first treatment cycle
Time frame: through study completion, an average of 6 months
Incidence of Grade 3 or higher ANC reduction across all observation cycles
Incidence of Grade 3 or higher ANC reduction across all observation cycles
Time frame: through study completion, an average of 6 months
Proportion of patients experiencing treatment delays (≥7 days) due to infection or neutropenia
Proportion of patients experiencing treatment delays (≥7 days) due to infection or neutropenia
Time frame: through study completion, an average of 6 months
Clinical efficacy of treatment in patients, VGPR rate, CR rate, MRD negative rate
Clinical efficacy of treatment in patients, VGPR rate, CR rate, MRD negative rate
Time frame: through study completion, an average of 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 6 months
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