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

Korábbi kezelés

• 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);

Más betegség

• 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.

Laborértékek

• 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；

Egyéb

• Lymphoma patients with bone marrow involvement or patients with MM who had >10% bone marrow involvement at screening ;
• Patients who are pregnant or breastfeeding

• 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