Actively Recruiting
Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-05-13
120
Participants Needed
7
Research Sites
231 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
J
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter prospective study to evaluate the efficacy and safety of chemotherapy combined with a single dose of subcutaneous(SC) injection mecapegfilgrastim on day 2 or day 5 after chemotherapy for autologous peripheral blood stem cell (PBSC) mobilization in patients with multiple myeloma or lymphoma.
CONDITIONS
Official Title
Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lymphoma patients with two or fewer prior therapies, multiple myeloma patients with one prior therapy
- Patients who have achieved at least partial response (PR)
- Eligible for autologous peripheral blood stem cell transplantation
- Age between 18 and 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of more than three months
- Fertile patients must use reliable contraception during the study and for 90 days after last dose, with a negative pregnancy test within 72 hours before first dose
- Able and willing to provide written informed consent before any study procedures
You will not qualify if you...
- Previous attempt at hematopoietic stem cell mobilization
- Previous bone marrow transplantation
- Lymphoma patients with bone marrow involvement or multiple myeloma patients with more than 10% bone marrow involvement at screening
- History of significant heart disease including angina, myocardial infarction, coronary stent, uncontrolled arrhythmias, cardiac insufficiency, QTc interval >500ms, left ventricular ejection fraction <60%, or other heart conditions unsuitable for stem cell mobilization or transplantation
- Uncontrolled pulmonary infection
- Laboratory values below specified thresholds: white blood cell count <2.5×10⁹/L, absolute neutrophil count <1.5×10⁹/L, platelets count <80×10⁹/L, creatinine above 2.0 times upper limit of normal or creatinine clearance ≤60 ml/min, liver enzymes (AST/ALT/total bilirubin) >2.5 times upper limit of normal
- Prior treatment with more than 4 cycles of lenalidomide or lenalidomide within 4 weeks before mobilization chemotherapy
- Prior treatment with fludarabine or melphalan
- Planned radiation within 30 days after transplantation or prior pelvic radiation
- Allergy to mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or E. coli formulations
- Pregnant or breastfeeding
- Participation in other clinical trials or less than 4 weeks since last study drug dose before mobilization chemotherapy
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
4
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
5
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
6
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
7
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
Research Team
W
Wei Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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