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
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
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 armssCS1 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
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
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