A Phase 1 Study of LY2127399 in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma
version:
date:
Eli Lilly Japan K.K.
0120-360-605
Interventional
1
* 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).
20age old over
No limit
Both
Multiple Myeloma
investigational material(s)
Generic name etc : LY2127399
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 100 mg or 300 mg LY2127399 IV on day 1 of each cycle. Bortezomib (1.3 mg/m^2) IV or SC on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (20 mg/day) on day of and day after bortezomib.
