Prospective Follow-up of Relapse Myeloma Patients after Previous Exposure to Bortezomib and Lenalidomide Treated on Pomalidomide and Dexamethasone - Phase II trial on Pomalidomide and Dexamethazone treatment for relapsed multiple myeloma (AMN001/J-MEN009 (POM-DEX))

PO Epidemiological and Clinical Research Information Network (ECRIN)0 个研究点目标入组 40 人开始时间: 2015年8月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Female patients who are lactating or pregnant 2)Multiple Myeloma of IgM subtype 3)Glucocorticoid therapy within 14 days 4)POEMS syndrome 5)Plasma cell leukemia or circulating plasma cells more than 2 x 109/L 6)Macroglobulinaemia 7)Known amyloidosis 8)Chemotherapy with anticancer therapeutics within 21 days prior to starting pomalidomide treatment 9)Focal radiation therapy or radiation therapy to an extended field. 10)Immunotherapy 11)Major surgery within 28 days 12)Active CHF, symptomatic ischaemia, or conduction abnormalities. Myocardial infarction within 4 months prior. 13)Known HIV, HCV, HBV-positivity. (except for patients with HBs-Ag or HBc-Ab responding to antiviral therapy: these patients are allowed) 14) Known cirrhosis 15)Second malignancy within the past 3 years. 16)Patients with MDS 17)Patients with steroid or lenalidomide hypersensitivity 18)Prior treatment with pomalidomide 19)Ongoing GVHD 20)Patients with pleural effusions or ascites 21)Contraindication to any of the required concomitant drugs or supportive treatments 22)Any clinically significant medical disease or psychiatric condition.

发起方

PO Epidemiological and Clinical Research Information Network (ECRIN)