PROSPECTIVE STUDY OF MELPHALAN, PREDNISOLONE AND LENALIDOMIDE IN THE TREATMENT OF ELDERLY PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

Dr Geetha0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Written informed consent
•Newly diagnosed MM > 65 yrs of age based on the myeloma diagnostic criteria (Appendix A)
•Patients more than 60 years of age but not eligible for Bone marrow transplant
•Not received previous systemic treatment for MM (except steroids for less than 14 days)
•Performance status of <= 2 on ECOG performance scale (Appendix C)
•Note: Patients who are bedridden due to local cause(eg. Back ache) will be considered for the study.
•Patient has measurable disease, defined as any quantifiable serum M protein value and / or when applicable, urine M protein >= 200 mg/ 24 hrs or bone marrow plasma cells > 10%.
•Patient must have adequate organ function as indicated by the lab tests (Hemoglobin > 8 g/dL, Platelet count > 75000/mmÂ³, ANC > 1,000/mmÂ³, Creatinine < 2.5 mg/dL, Direct bilirubin <= 1.5 mg/dL, ALT and AST <= 2.5 times upper limit of normal(ULN))

•1.Patient has uncontrolled inter current infections or circumstances that could limit compliance with the study â?? renal failure, uncontrolled hypertension, symptomatic CCF, angina pectoris, MI in the past 6 months, uncontrolled cardiac arrhythmias
•2.Patient has known hyper sensitivity to any components of the study regimen
•3.Patient has a history of illicit drug use/substance abuse
•4.Patient is known to be HIV positive
•5.Patient has clinically active hepatitis B/C defined as disease that requires specific therapy

发起方

Dr Geetha