A Study on the Use of Sulpegfilgrastim to Prevent the Incidence of Neutropenia With Infection in Newly Diagnosed Non-transplant Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Incidence of infection during oncological treatment
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all the following criteria to be eligible for this study:
- •Age ≥ 18 years old，weight > 35 kg，regardless of gender;
- •Voluntarily participating in the study after signing the informed consent form;
- •Newly diagnosed, non-transplanted multiple myeloma patients diagnosed according to the 2016 International Myeloma Working Group (IMWG) criteria or the 2024 Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma, and expected to receive at least six cycles of DRD (CD38 monoclonal antibody + lenalidomide + dexamethasone) oncological treatment;
- •Deemed suitable for sulpegfilgrastim administration by the investigator;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2, with an expected survival of at least three months;
- •Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 75.0×10⁹/L；
- •Serum creatinine clearance rate ≥30 mL/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤three times the upper limit of normal。
- •Negative pregnancy test for women of childbearing age. Patients and their spouses must agree to use effective contraceptive measures during treatment and for one year thereafter；
- •Signed informed consent for chemotherapy. In cases where the patient is unable to sign due to impaired consciousness, upper limb paralysis, or illiteracy, a legal representative may sign on their behalf.
排除标准
- •Patients meeting any of the following criteria are excluded from this study：
- •Weight≤35kg；
- •Monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, or primary light chain amyloidosis with organ involvement;
- •Diagnosed or treated for another malignancy within one year prior to registration, or evidence of residual disease from a previous malignancy requiring ongoing treatment;
- •Known positive for human immunodeficiency virus (HIV);
- •Pregnant or breastfeeding women;
- •Patients with any active acute infection, including viral infections;
- •Patients who have received systemic antibiotic treatment within two weeks prior to enrollment;
- •Allergy to Sulfubrolipoyl G-CSF, pegylated recombinant human granulocyte colony-stimulating factor, recombinant human granulocyte colony-stimulating factor, or other agents expressed in E. coli; Other situations where the investigator deems participation in the study inappropriate.
研究组 & 干预措施
experimental arm
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.
干预措施: sulpegfilgrastim (Drug)
结局指标
主要结局
Incidence of infection during oncological treatment
时间窗: through study completion, an average of 6 months
Incidence of infection during oncological treatment
次要结局
- Incidence of febrile neutropenia (FN)(through study completion, an average of 6 months)
- Incidence of infection in patients with ANC <1.0×10⁹/L(through study completion, an average of 6 months)
- Proportion of patients requiring dose adjustment due to ANC reduction or infection(through study completion, an average of 6 months)
- Incidence of Grade 3 or higher ANC reduction across all observation cycles(through study completion, an average of 6 months)
- Proportion of patients experiencing treatment delays (≥7 days) due to infection or neutropenia(through study completion, an average of 6 months)
- Clinical efficacy of treatment in patients, VGPR rate, CR rate, MRD negative rate(through study completion, an average of 6 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(through study completion, an average of 6 months)
- Incidence of Grade 3 or higher ANC reduction in the first treatment cycle(through study completion, an average of 6 months)