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

Stopped early · Phase 3

Conditions studied: Newly Diagnosed, Previously Untreated Multiple Myeloma

In brief

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

Key facts

Study ID

NCT01891643

Run by

Bristol-Myers Squibb

People needed

23

Starts

2013-09-30

Expected to finish

2020-06-25

Last updated by the study team

2021-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Memorial Cancer Institute — Hollywood, Florida, United States
• Illinois Cancercare, Pc — Peoria, Illinois, United States
• Franciscan St. Francis Health — Indianapolis, Indiana, United States
• Crescent City Research Consortium, LLC — Marrero, Louisiana, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Medical University Of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States
• Baptist Cancer Center — Memphis, Tennessee, United States
• Northern Utah Associates — Ogden, Utah, United States
• Local Institution — Athens, Greece
• Local Institution — Genova, Italy
• Local Institution — Rome, Italy
• Local Institution — Chorzów, Poland
• Local Institution — Lublin, Poland

Full record on ClinicalTrials.gov

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