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Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Phase 1 Study of Tabalumab (LY2127399) in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effect on the body of Tabalumab (LY2127399) in combination with bortezomib and dexamethasone in Japanese participants with relapsed or refractory multiple myeloma (MM).

Clinical Trial Description

The study has 3 cohorts. Cohort 2 and cohort 2-SC will be conducted in parallel with some data presented combined.

Cohort 1 - Participants will receive 100 mg Tabalumab (LY2127399) intravenously (IV), 1.3 milligram per square meter (mg/m^2) bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2 - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m^2 bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2-SC - Participants will receive 300 mg Tabalumab (LY2127399) IV, 1.3 mg/m^2 bortezomib subcutaneously (SC), and 20 mg dexamethasone orally.

Cohort 2-SC was added per protocol amendment in February 2013. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01556438
Study type Interventional
Source Eli Lilly and Company
Contact
Status Completed
Phase Phase 1
Start date July 2012
Completion date August 2015
View Details
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