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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Newly Diagnosed, Previously Untreated Multiple Myeloma

Intervention: Lenalidomide (Drug); Dexamethasone (Drug); Elotuzumab (Biological)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: Change from baseline to progression of the cell surface expression of CS1 from bone marrow-derived MM cells in both treatment arms

Secondary outcome:

Level of cell surface CS1 from bone marrow-derived MM cells in both treatment arms

sCS1 levels in serum and to evaluate change from baseline and during therapy and at progression in both treatment arms

The presence, and the change from baseline, on therapy, and at progression, of circulating MM cell numbers and their CS1 cell surface expression in both treatment arms

The cell number and CS1 expression patterns between matched samples of bone marrow-derived MM cells and circulating MM cells at baseline and at progression in both treatment arms


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Local Institution, Athens 11528, Greece

Local Institution, Genova 16132, Italy

Local Institution, Rome 00161, Italy

Local Institution, Chorzow 41-500, Poland

Local Institution, Lublin 20-081, Poland

Pacific Hematology Oncology Associates, San Francisco, California 94115, United States

Memorial Cancer Institute, Hollywood, Florida 33021, United States

Illinois Cancercare, Pc, Peoria, Illinois 61615, United States

Franciscan St. Francis Health, Indianapolis, Indiana 46237, United States

Crescent City Research Consortium, LLC, Marrero, Louisiana 70072, United States

Ohio State University Medical Center, Columbus, Ohio 43210, United States

Medical University Of South Carolina Hollings Cancer Center, Charleston, South Carolina 29425, United States

Baptist Cancer Center, Mephis, Tennessee 38120, United States

Northern Utah Associates, Ogden, Utah 84405, United States

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: September 2013
Last updated: August 11, 2015

Page last updated: August 23, 2015

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