Multiple Myeloma Clinical Trial
Official title:
Prospective, Single-arm, Multicenter Exploratory Clinical Study of the Combination of Etoposide, Cytarabine and PEG-rhG-CSF (EAP Regimen) as First Line Mobilization Regimen of Hematopoietic Stem Cells in Patients With Hematological Malignancies
This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) as first line mobilization regimen of hematopoietic stem cells in patients with lymphoma and multiple myeloma. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.
In patients older than 65 years, or with creatinine >2.5 mg/dL but with an endogenous creatinine clearance >50%, the dose of etoposide and Ara-C should be reduced by one-quarter to one-third. Routinely blood analyses and peripheral blood CD34+ cells monitored will be performed daily from day 9 to the end of HSC collection or the abandonment of HSC collection. If the WBC count is ≤10×109/L, 5μg/kg/d of G-CSF should be injected subcutaneously until the end of HSC collection. Leukapheresis can be performed when the white blood cell counts recover (WBC count was≥4×109/L) following chemotherapy and the CD34+ cell count was≥20/μL. Leukapheresis started if the peripheral blood CD34+ counts plateaued at ≥5 cells/μL and <20 cells/μL after recovery of white blood cell counts following chemotherapy, the clinician decided whether to add plerixafor based on the specific situation of the patient. Leukapheresis should be abandoned if the peak circulating CD34+ cells were <5/μL up to 20 days after chemotherapy. CD34+ cells were determined by multi-parameter flow cytometry and a dual-platform approach. Two blood cell separators were used at the study sites: Spectra-Optia Apheresis system (Terumo BCT, Lake-wood, CO, USA) , COM.TEC (Fresenius Kabi). During each leukapheresis, 2.5 times the patients' blood volume (±25%) had to be processed within 5 h. ;
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