Phase
Condition
Multiple Myeloma
Cancer/tumors
Lymphoproliferative Disorders
Treatment
Mecapegfilgrastim, day 5
Etoposide
Mecapegfilgrastim, day 2
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Lymphoma patients with ≤2 lines of prior therapy, patients with multiple myelomawith 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 clinicalstudy period and for 90 days after the last dose and have a negative serologicalpregnancy test within 72 hours prior to the first dose.
Patients must be able and willing to give written informed consent prior to anystudy-related procedures
Exclusion
Exclusion Criteria:
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% bonemarrow involvement at screening ;
Patients with angina pectoris, myocardial infarction, coronary stent implantation,uncontrolled arrhythmias (atrial tachycardia, atrial fibrillation, persistentventricular arrhythmias, etc.), cardiac insufficiency, Q-Tc interval >500ms, leftventricular ejection fraction (EF)<60%, or other heart diseases that theinvestigator considers unsuitable for hematopoietic stem cell mobilization orhematopoietic 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 orreceived lenalidomide within 4 weeks prior to hematopoietic stem cellmobilization 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 lastdose of prior study drug to the mobilization chemotherapy is less than 4 weeks (or 5half-lives of the study drug);
Patients with other conditions unsuitable for this study according to theinvestigator's judgment.
Study Design
Study Description
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, Shandong
ChinaSite Not Available
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin 300020
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin
ChinaSite Not Available
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