Status:
RECRUITING
Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Conditions:
Multiple Myeloma
Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 chemothe...
Detailed Description
Subjects eligible for autologous stem-cell transplantation are randomized to receive a single dose of 12mg mecapegfilgrastim SC on day 2 or day 5 after chemotherapy for PBSC mobilization. According to...
Eligibility Criteria
Inclusion
- Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myeloma with one line of therapy;
- Patients who had achieved at least partial response (PR);
- Patients who were eligible for autologous peripheral blood stem cell transplantation
- Age≥18 and≤65 years;
- Patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Patients who have an estimated life expectancy of more than three months
- Fertile patients must be willing to use reliable contraception during the clinical study period and for 90 days after the last dose and have a negative serological pregnancy test within 72 hours prior to the first dose.
- Patients must be able and willing to give written informed consent prior to any study-related procedures
Exclusion
- Patients who had previously attempted hematopoietic stem cell mobilization;
- Patients who had undergone previous bone marrow transplantation;
- Lymphoma patients with bone marrow involvement or patients with MM who had \>10% bone marrow involvement at screening ;
- Patients with angina pectoris, myocardial infarction, coronary stent implantation, uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistent ventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval \>500ms, left ventricular ejection fraction (EF)\<60%, or other heart diseases that the investigator considers unsuitable for hematopoietic stem cell mobilization or hematopoietic stem cell transplantation;
- Patients with uncontrolled pulmonary infection;
- Patients who had any of the following laboratory indicators:
- White blood cell count(WBC)\<2.5×109/L；
- Absolute neutrophil count(ANC)\<1.5×109/L；
- Platelets count(PLT)\<80×109/L；
- Creatinine \> 2.0 X ULN of the reference range or creatinine clearance ≤60ml/min
- AST/ALT/Total bilirubin \> 2.5 X ULN；
- Patients who have received any of the following treatments:
- Patients who had been treated with more than 4 cycles of lenalidomide or received lenalidomide within 4 weeks prior to hematopoietic stem cell mobilization chemotherapy.
- Patients who previously been treated with fludarabine or melphalan;
- Patients who plan to receive radiation within 30 days after transplantation
- Patients who had received radiation therapy in the pelvis
- Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli.
- Patients who are pregnant or breastfeeding
- Patients who are participating in other clinical studies or the interval of the last dose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5 half-lives of the study drug);
- Patients with other conditions unsuitable for this study according to the investigator's judgment.
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05294055
Start Date
April 26 2022
End Date
September 30 2026
Last Update
May 13 2025
Active Locations (7)
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1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Peking University Third Hospital
Beijing, Beijing Municipality, China
3
Henan Cancer Hospital
Zhengzhou, Henan, China
4
Shandong Cancer Hospital
Jinan, Shandong, China