Multiple Myeloma Clinical Trial
PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy)
Summary
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
Eligibility Criteria
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
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There are 14 Locations for this study
San Francisco California, 94115, United States
Hollywood Florida, 33021, United States
Peoria Illinois, 61615, United States
Indianapolis Indiana, 46237, United States
Marrero Louisiana, 70072, United States
Columbus Ohio, 43210, United States
Charleston South Carolina, 29425, United States
Memphis Tennessee, 38120, United States
Ogden Utah, 84405, United States
Athens , 11528, Greece
Genova , 16132, Italy
Rome , 00161, Italy
Chorzow , 41-50, Poland
Lublin , 20-08, Poland
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