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

ConditionsMultiple MyelomaDRDSulpegfilgrastimNeutropenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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);

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of infection during oncological treatment

Incidence of infection during oncological treatment

Time frame
through study completion, an average of 6 months

Secondary outcomes

1

Incidence of febrile neutropenia (FN)

Incidence of febrile neutropenia (FN)

Time frame
through study completion, an average of 6 months
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: