Mecapegfilgrastim With Chemotherapy for Peripheral Blood Stem Cell Mobilization in MM and Lymphoma

Exclusion Criteria20

• 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.