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

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective a medication called sulpegfilgrastim is in preventing infections in patients who are newly diagnosed with multiple myeloma and are not undergoing a transplant. Multiple myeloma is a type of cancer that affects plasma cells in the blood. The study will focus on patients who are expected to receive a specific treatment regimen and aims to see if sulpegfilgrastim can help keep their immune system strong enough to fight off infections.

To be eligible for this trial, participants need to be adults aged 18 or older, weigh more than 35 kg, and have been recently diagnosed with multiple myeloma. They should be planning to receive a certain type of chemotherapy for at least six cycles and be in good overall health. Patients must also provide consent to participate and meet other health criteria. If you or someone you know is interested in learning more, it’s essential to discuss this with a healthcare provider who can provide further information about the trial and its potential benefits.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Patients must meet all the following criteria to be eligible for this study:
• • 1. Age ≥ 18 years old，weight \> 35 kg，regardless of gender;
• • 2. Voluntarily participating in the study after signing the informed consent form;
• • 3. 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;
• • 4. Deemed suitable for sulpegfilgrastim administration by the investigator;
• • 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2, with an expected survival of at least three months;
• • 6. Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; platelet count (PLT) ≥ 75.0×10⁹/L；
• • 7. Serum creatinine clearance rate ≥30 mL/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤three times the upper limit of normal。
• • 8. 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；
• • 9. 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.
• Exclusion Criteria:
• • Patients meeting any of the following criteria are excluded from this study：
• • 1. Weight≤35kg；
• • 2. Monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, or primary light chain amyloidosis with organ involvement;
• • 3. Diagnosed or treated for another malignancy within one year prior to registration, or evidence of residual disease from a previous malignancy requiring ongoing treatment;
• • 4. Known positive for human immunodeficiency virus (HIV);
• • 5. Pregnant or breastfeeding women;
• • 6. Patients with any active acute infection, including viral infections;
• • 7. Patients who have received systemic antibiotic treatment within two weeks prior to enrollment;
• • 8. 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.