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: 待定

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