Mecapegfilgrastim with chemotherapy to collect stem cells in myeloma or lymphoma

Trial details

Who runs it

Institute of Hematology & Blood Diseases Hospital, China

Trial code

NCT05294055

Record updated

13 May 2025

Original description

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.Read full original descriptionShow less

A Prospective and Multicenter Clinical Study of Mecapegfilgrastim in Combination With Chemotherapy for Autologous Peripheral Blood Stem Cell Mobilization in Patients With Multiple Myeloma or Lymphoma

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.

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; 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 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 uncontrolled pulmonary infection; Patients allergic to Mecapegfilgrastim, pegylated granulocyte stimulating factor, granulocyte stimulating factor, or other formulations expressed by E. coli; Patients with other conditions unsuitable for this study according to the investigator's judgment; 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 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；; Lymphoma patients with bone marrow involvement or patients with MM who had >10% bone marrow involvement at screening ; Patients who are pregnant or breastfeeding.

ClinicalTrials.gov NCT05294055