PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)

Status:	Active, not recruiting
Conditions:	Hematology, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	18 - Any
Updated:	1/20/2018
Start Date:	September 30, 2013
End Date:	July 31, 2020

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

The purpose of the study is to look at subjects who receive Lenalidomide, Dexamethasone, and
Elotuzumab and determine if they will have lower surface CS1 expression on malignant plasma
cells at the time of progression than those who receive Lenalidomide and Dexamethasone
without Elotuzumab

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

Subjects who are newly diagnosed with symptomatic MM and who:

- Have not received any prior systemic anti-myeloma therapy

- Have measurable disease

- And are not candidates for high-dose therapy plus stem-cell transplantation (SCT)
because of age (≥65 years) or coexisting conditions. Refusal to undergo high dose
therapy with SCT is NOT sufficient for entry onto CA204-006 for a subject <65 years
old. There must be a comorbidity that prevents SCT for a subject <65 years old

Exclusion Criteria:

- Subjects with non-secretory or oligo-secretory or free light-chain only myeloma

- Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions

- Monoclonal Gammopathy of Undetermined Significance (MGUS)

- Active plasma cell leukemia

- Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

We found this trial at

sites

Pacific Hematology Oncology Associates

San Francisco, California 94115

680

from 98109

San Francisco, CA