A Phase 1 Study of LY2127399 in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma

Eli Lilly Japan K.K.0 个研究点开始时间: 2012年3月21日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•* Have relapsed or refractory MM treated with at least 1 prior regimen.
•* Have measurable disease as defined by one or more of the following
•-serum M-protein concentration greater than or equal to 1 g/dL (10 g/L)
•-urine monoclonal light chain concentration greater than or equal to 200 mg/24 hours as determined by urine protein electrophoresis
•-involved serum free light chain (SFLC) concentration greater than or equal to 10 mg/dL (100 mg/L)and an abnormal SFLC ratio
•* Have adequate organ function (hematopoietic function, liver function, renal function).
•* Have an Eastern Cooperative Oncology Group performance status (ECOG PS) score of less than or equal to 2.

•* Have one or more serious preexisting medical conditions that, in the opinion of the investigator, would preclude participation in this study.
•* Have known positive test results for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
•* Have greater than or equal to Grade 2 peripheral neuropathy or any grade with pain as assessed using the Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v 4.03).
•* Have previously received an allogenic hematopoietic stem cell transplant.
•* Have a corrected QT (QTc) interval >470 msec on their baseline electrocardiogram (ECG).

发起方