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

2014-09-25 15:08:23 | BioPortfolio

Summary

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

Description

The study has 3 cohorts. Participants will only enroll in one cohort. Cohort 2 and cohort 2-SC will be conducted in parallel.

Cohort 1 - Participants will receive 100 mg 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 LY2127399 IV, 1.3 mg/m^2 bortezomib IV, and 20 mg dexamethasone orally.

Cohort 2-SC - Participants will receive 300 mg 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

LY2127399, Bortezomib IV, Bortezomib SC, Dexamethasone

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559)
Aichi
Japan
467-0001

Status

Active, not recruiting

Source

Eli Lilly and Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-25T15:08:23-0400

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Medical and Biotech [MESH] Definitions

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

An asymptomatic and slow-growing PLASMA CELL dyscrasia characterized by presence of MYELOMA PROTEINS and clonal bone marrow plasma cells without end-organ damage (e.g., renal impairment). It is distinguished from MONOCLONAL GAMMOPATHY OF UNDETERMINED SIGNIFICANCE by a much higher risk of progression to symptomatic MULTIPLE MYELOMA.

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

An abnormal protein with unusual thermosolubility characteristics that is found in the urine of patients with MULTIPLE MYELOMA.

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