Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients
NCT ID: NCT02159365
Last Updated: 2019-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
84 participants
INTERVENTIONAL
2014-03-08
2018-07-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Elotuzumab + Lenalidomide/Dexamethasone
Elotuzumab 10 mg/kg solution intravenously weekly in cycle 1 and 2, then every other week, Lenalidomide 25 mg tablet by mouth Days 1-21 of each cycle / Dexamethasone 40 mg tablet by mouth / solution intravenously weekly until progression or discontinuation of Elotuzumab
Elotuzumab
Lenalidomide
Dexamethasone
Interventions
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Elotuzumab
Lenalidomide
Dexamethasone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented evidence of active multiple myeloma:
* Newly diagnosed, not candidate for transplant
* Relapsed/refractory who have received up to 3 prior lines of therapy
* Prior Lenalidomide exposure is permitted only if the following criteria are fulfilled:
* Not refractory to prior Lenalidomide which is defined as no progression while receiving Lenalidomide or within 60 days of last dose of Lenalidomide
* Subject did not discontinue Lenalidomide due to a Grade ≥3 related adverse event (AE)
Exclusion Criteria
* Plasma cell leukemia
* Monoclonal gammopathy of undetermined significance (MGUS)
* Smoldering Myeloma
* Primary amyloidosis
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Acrc/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Highland Oncology Group
Fayetteville, Arkansas, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
California Cancer Associates for Research and Excellence
Encinitas, California, United States
Compassionate Cancer Res Grp
Fountain Valley, California, United States
Robert A. Moss, Md Facp, Inc.
Fountain Valley, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
Pacific Cancer Care
Monterey, California, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States
Wellness Oncology & Hematology
West Hills, California, United States
James R. Berenson, MD, Inc.
West Hollywood, California, United States
Rocky Mountain Cancer Centers Llp
Denver, Colorado, United States
Cancer Specialists Of North Florida
Jacksonville, Florida, United States
Center For Cancer Care & Research
Lakeland, Florida, United States
Baptist Health Medical Group Oncology
Miami, Florida, United States
Oncology Specialists,S.C
Park Ridge, Illinois, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States
Horizon Oncology Research, Inc
Lafayette, Indiana, United States
Clinical Research Alliance, Inc.
New York, New York, United States
St Francis Hospital
Greenville, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Texas Oncology
Dallas, Texas, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Local Institution
Houston, Texas, United States
Cancer Centers of South Texas
San Antonio, Texas, United States
Blood & Cancer Center of East Texas
Tyler, Texas, United States
Texas Oncology-McAllen South Second Street
Weslaco, Texas, United States
Blue Ridge Cancer Care
Blacksburg, Virginia, United States
Vista Oncology Inc., PS
Olympia, Washington, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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CA204-112
Identifier Type: -
Identifier Source: org_study_id
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