Interleukin 2 and zolendronic acid as maintaining treatment in multiple myeloma patients after autologous bone marrow transplant

AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA0 个研究点开始时间: 2013年6月3日最近更新: 2014年2月10日

适应症

试验速览

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•Multiple Myeloma patients underwent to autologous bone marrow transplant, Patients between 18 and 70 yrs, Patients evaluated three months later the bone marrow transplant and in VGPR with measurable disease ( M protein or immunofixation presence) ECOG performance status < 2, Written consent before any procedure
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•Not responder patients after autologous bone marrow transplant, renal impairment as creatinine level > 3 mg/ml (265µmol/L) or clearance < 30 ml/min active dental disease, previous story or planned oral surgery (within 6 weeks), Abnormal serum calcium levels < 8.0 mg/dL (2 mmol/L) o > 12 mg/dL (3 mmol/L), Pregnancy or absence of pregnancy prevention (for women in reproduction age), Psychiatric disease, Liver disease, Cardiopathy, Active infection, Disease of autoimmunity, Bone pathology, Other recent (within 30 days) treatment in clinical investigation study, Bone disease (ie. Paget), Adverse reaction to zolendronic acid and/or interleukin -2

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