Multiple MyelomaNCT07018271
A Study on the Use of Sulpegfilgrastim to Prevent the Incidence of Neutropenia With Infection in Newly Diagnosed Non-transplant Multiple Myeloma Patients
A study testing sulpegfilgrastim in people with Multiple Myeloma and DRD, run by The First Affiliated Hospital of Soochow University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, DRD, Sulpegfilgrastim
- What is being tested?
- sulpegfilgrastim
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
About this study
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).
Read the detailed description
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).
- Conditions
- Multiple Myeloma, DRD, Sulpegfilgrastim, Neutropenia
- Being tested
- sulpegfilgrastim
- Medical subject headings
- Multiple Myeloma, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulpegfilgrastimDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: sulpegfilgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infection during oncological treatment
Incidence of infection during oncological treatment
Measured: through study completion, an average of 6 months
Secondary outcomes (8)
Incidence of febrile neutropenia (FN)
Incidence of febrile neutropenia (FN)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018271
- Sponsor's protocol ID
- Sulpegfilgrastim in NDMM
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Use of Sulpegfilgrastim to Prevent the Incidence of Neutropenia With Infection in Newly Diagnosed Non-transplant Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT07018271
- Acronym / sponsor ID
- Sulpegfilgrastim in NDMM
- Conditions
- Multiple Myeloma, DRD, Sulpegfilgrastim, Neutropenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Drug: sulpegfilgrastimOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulpegfilgrastimOn 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. | Drug | experimental arm |
Primary outcome
Incidence of infection during oncological treatment
Time frame: through study completion, an average of 6 months
Incidence of infection during oncological treatment
8 secondary outcomes
Incidence of febrile neutropenia (FN)
Time frame: through study completion, an average of 6 months
Incidence of infection in patients with ANC <1.0×10⁹/L
Time frame: through study completion, an average of 6 months
Proportion of patients requiring dose adjustment due to ANC reduction or infection
Time frame: through study completion, an average of 6 months
Incidence of Grade 3 or higher ANC reduction in the first treatment cycle
Time frame: through study completion, an average of 6 months
Incidence of Grade 3 or higher ANC reduction across all observation cycles
Time frame: through study completion, an average of 6 months
Proportion of patients experiencing treatment delays (≥7 days) due to infection or neutropenia
Time frame: through study completion, an average of 6 months
Clinical efficacy of treatment in patients, VGPR rate, CR rate, MRD negative rate
Time frame: through study completion, an average of 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sulpegfilgrastim in people with Multiple Myeloma and DRD, run by The First Affiliated Hospital of Soochow University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of infection during oncological treatment (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.