Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in elderly patients in 1st relapse or primary refractory after first line therapy for multiple myeloma. - HOVON 86 MM

HOVO0 个研究点目标入组 68 人开始时间: 待定最近更新: 2024年5月13日

研究概览

暂无简介。

•-Multiple Myeloma Salmon/Durie stage II/III A+B
•-Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment
•-Age 60-85 years
•-Not a candidate for high-dose therapy
•-Measurable disease, i.e., serum M-compenent (>10 g/l), or urinary light-chain excretion (>200mg/24h), or abnormal free light chain (FLC) ratio with involved FLC > 100 mg/l or proven plasmacytoma by biopsy
•-Able and/or willing to use adequate contraceptives (especially male patients)
•-Written informed consent

•-Prior therapy with Bortezomib or Lenalidomide
•-History of allergic reaction to compounds containing boron or mannitol
•-Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 3
•-AL amyloidosis
•-Uncontrolled or severe cardiovascular disease:
•-New York Heart Association (NYHA) Class II or IV heart failure
•-Myocardial infarction within the last 6 months of study entry
•-Reduced left ventricular function with an ejection fraction *50% as measured
•by MUGA scan or echocardiogram (another method for measuring cardiac function
•is acceptable)
•-Unstable angina
•-Unstable cardiac arrhytmias
•-Clinically significant pericardial disease
•-Impaired hepatic or renal function
•-ALT and/or AST > 3 x normal value
•-Bilirubin > 3 x normal value
•-Serum creatinin > 3 x normal value (after adequate hydration)
•-Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)
•-Known HIV positivity
•-History of active malignancy in past 5 years

发起方

HOVO