Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
NCT ID: NCT01478048
Last Updated: 2018-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
185 participants
INTERVENTIONAL
2011-11-30
2017-04-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Elotuzumab + Bortezomib + Dexamethasone
On days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) will be administered other days Dexamethasone 20 mg Oral will be administered
Elotuzumab
Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
Bortezomib
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Tablets; Oral; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Tablets; Oral; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
Arm B: Bortezomib + Dexamethasone
Bortezomib
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug
Interventions
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Elotuzumab
Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 \& 2: Days 1, 8 \& 15; Cycles 3-8: Days 1 \& 11; Cycle 9+: Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
Bortezomib
Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Tablets; Oral; 20 mg; (Cycles 1\& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Tablets; Oral; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Solution; IV; 8 mg; (Cycles 1\& 2: Days 1, 8, 15; Cycles 3-8: Days 1 \&11; Cycles 9+; Days 1 \& 15); Until subject meets criteria for discontinuation of study drug
Dexamethasone
Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease
* 1 to 3 prior lines of therapy
* Subjects may be proteasome inhibitor naive or have received prior proteasome inhibitor therapy provided all the following criteria are met:
1. The subject did not discontinue any proteasome inhibitor due to intolerance or grade ≥ 3 toxicity
2. The subject is not refractory to any proteasome inhibitor, defined as progression during treatment or within 60 days after the last dose
3. The subject previously achieved a partial response (PR) or better to previous proteasome inhibitor (PI)
Exclusion Criteria
* Active plasma cell leukemia
* Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
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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Compassionate Cancer Res Grp
Corona, California, United States
Local Institution
Corona, California, United States
Local Institution
Long Beach, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Ucla Department Of Medicine
Los Angeles, California, United States
Medical Oncology Care Associates
Orange, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Local Institution
Vallejo, California, United States
Cancer Specialists of North FL
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Kaiser Permanente-Moanalua Medical Center
Honolulu, Hawaii, United States
University Of Chicago Medical Center
Chicago, Illinois, United States
Local Institution
Decatur, Illinois, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Local Institution
Urbana, Illinois, United States
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, United States
Local Institution
Hazard, Kentucky, United States
University Of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Pikeville Medical Center Leonard Lawson Cancer Center
Pikeville, Kentucky, United States
Cancer Center Of Acadiana
Lafayette, Louisiana, United States
Local Institution
Shreveport, Louisiana, United States
Local Institution
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
Washington University School Of Medicine
St Louis, Missouri, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Waverly Hematology Oncology
Cary, North Carolina, United States
St. Agnes Hospital
Baltimore, Pennsylvania, United States
Cancer Care Associates
Bethlehem, Pennsylvania, United States
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States
Penn State Hershey Cancer Inst
Hershey, Pennsylvania, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Local Institution
Greenville, South Carolina, United States
Charles A. Sammons Cancer Center
Dallas, Texas, United States
Northwest Cancer Center
Houston, Texas, United States
Local Institution
Fairfax, Virginia, United States
Local Institution
Seattle, Washington, United States
Local Institution
Halifax, Nova Scotia, Canada
Local Institution
Grenoble, , France
Local Institution
Le Mans, , France
Local Institution
Lille, , France
Local Institution
Nantes, , France
Local Institution
Paris, , France
Local Institution
Toulouse, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Local Institution
Milan, Parma, Italy
Local Institution
Roma, Parma, Italy
Local Institution
Ancona, , Italy
Local Institution
Bari, , Italy
Local Institution
Bologna, , Italy
Local Institution
Brescia, , Italy
Local Institution
Florence, , Italy
Local Institution
Genova, , Italy
Local Institution
Lecce, , Italy
Local Institution
Meldola (fc), , Italy
Local Institution
Modena, , Italy
Local Institution
Pescara, , Italy
Local Institution
Ravenna, , Italy
Local Institution
Rimini, , Italy
Local Institution
Roma, , Italy
Local Institution
Roma, , Italy
Local Institution
Rome, , Italy
Local Institution
Torino, , Italy
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
Murcia, , Spain
Local Institution
Salamanca, , Spain
Local Institution
Santiago Compostela, , Spain
Local Institution
Toledo, , Spain
Local Institution
Valencia, , Spain
Local Institution
Valencia, , Spain
Local Institution
Zaragoza, , Spain
Countries
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References
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Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.
Related Links
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BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
Other Identifiers
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2011-002695-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA204-009
Identifier Type: -
Identifier Source: org_study_id
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