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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulpegfilgrastim | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of infection during oncological treatment | Incidence of infection during oncological treatment | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia (FN) | Incidence of febrile neutropenia (FN) | 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 |
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Inclusion Criteria:
Patients must meet all the following criteria to be eligible for this study:
Exclusion Criteria:
Patients meeting any of the following criteria are excluded from this study:
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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).
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| 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 | 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 | 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 | 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 | 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 | 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 | through study completion, an average of 6 months |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
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