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

NCT07018271 | Not Yet Recruiting

• 1 other identifier: Sulpegfilgrastim in NDMM
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Multiple Myeloma; DRD; Sulpegfilgrastim; Neutropenia

Outcome Measures

Primary Outcomes (1)

• Incidence of infection during oncological treatment

  Incidence of infection during oncological treatment

  through study completion, an average of 6 months

Secondary Outcomes (8)

• 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 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

  through study completion, an average of 6 months

Study Arms (1)

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.

Drug: sulpegfilgrastim

Interventions

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.

experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Multiple Myeloma; Neutropenia

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 12, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL