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Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

This study is currently recruiting participants.
Verified January 2013 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01478048
First received: November 2, 2011
Last updated: January 4, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will increase the time before myeloma worsens [progression free survival (PFS)].


Condition Intervention Phase
Multiple Myeloma
 Biological: Elotuzumab
Drug: Bortezomib
Drug: Dexamethasone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause [ Time Frame: Every 21 +/-7 days (Cycles 1-8) relative to the first dose of study medication ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause [ Time Frame: Every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS hazard ration in the subgroup of subjects with at least one FcγRIIIa V allele [ Time Frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
    Survival will be assessed every 12 weeks in the Follow Up Phase of the trial.

  • Difference in response rates between treatment arms in the overall population [ Time Frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
    Survival will be assessed every 12 weeks in the Follow Up Phase of the trial.

  • Estimate the difference in response rates between arms in the subgroup of subjects with at least one FcγRIIIa V allele [ Time Frame: Every 21 +/-7 days (Cycles 1-8) then every 28 +/- 7 days (Cycles 9+) relative to the first dose of study medication. ] [ Designated as safety issue: No ]
    Survival will be assessed every 12 weeks in the Follow Up Phase of the trial.


Estimated Enrollment: 150
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Biological: 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
Other Name: BMS-901608
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
Other Name: Velcade®
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
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®
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
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®
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
Other Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®
Active Comparator: Arm B: Bortezomib + Dexamethasone 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
Other Name: Velcade®
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 Names:
  • Decadron®
  • Dexamethasone
  • Intensol®
  • Dexpak®
  • Taperpak®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented progression from most recent line of therapy
  • 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:

  • Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, or Waldenstrom's macroglobulinemia
  • Active plasma cell leukemia
  • Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478048

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

  Hide Study Locations
Locations
United States, Arkansas
Local Institution Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Site 1923            
United States, California
Compassionate Cancer Care Medical Group, Inc Recruiting
Corona, California, United States, 92879
Contact: Haresh S Jhangiani, Site 1903     951-371-2411        
Local Institution Not yet recruiting
Corona, California, United States, 92879
Contact: Site 1976            
Local Institution Not yet recruiting
Long Beach, California, United States, 90806
Contact: Site 1979            
Local Institution Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Site 1927            
Ucla Department Of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Gary Schiller, Site 1928     310-825-5513        
Medical Oncology Care Associates Recruiting
Orange, California, United States, 92868
Contact: Birbal Bhaskar, Site 1911     714-541-6622        
Sharp Clinical Oncology Research Recruiting
San Diego, California, United States, 92123
Contact: Rajesh Belani, Site 1901     858-939-5062        
Local Institution Not yet recruiting
Vallejo, California, United States, 94589
Contact: Site 1920            
Local Institution Not yet recruiting
Vallejo, California, United States, 94589
Contact: Site 1958            
United States, Connecticut
Local Institution Not yet recruiting
Clinton, Connecticut, United States, 20735
Contact: Site 1950            
United States, Florida
Local Institution Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Site 1918            
Integrated Community Oncology Network Recruiting
Jacksonville, Florida, United States, 32256
Contact: Mehdi M Moezi, Site 1904     904-272-3139        
Local Institution Not yet recruiting
Miami Beach, Florida, United States, 33140
Contact: Site 1917            
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Shachar Peles, Site 1919            
United States, Hawaii
Local Institution Not yet recruiting
Honolulu, Hawaii, United States, 96819
Contact: Site 1972            
United States, Illinois
University Of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Andrzej Jakubowiak, Site 1944     773-702-6613        
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60607
Contact: Site 1951            
Cancer Care Specialists Of Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Contact: James L. Iii Wade, Site 1965            
Oncology Specialists, S.C. Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jacob D Bitran, Site 1975     847-268-8200        
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: James Egner, Site 1983     217-383-6963        
United States, Indiana
Investigative Clinical Research Of Indiana, Llc Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Robert F Manges, Site 1921     317-297-2208        
United States, Iowa
Local Institution Not yet recruiting
Iowa City, Iowa, United States, 52242
Contact: Site 1942            
United States, Kansas
Local Institution Not yet recruiting
Wichita, Kansas, United States, 67214
Contact: Site 1959            
United States, Kentucky
Kentucky Cancer Clinic Recruiting
Hazard, Kentucky, United States, 41701
Contact: Hassan H. Ghazal, Site 1929            
Local Institution Not yet recruiting
Lexington, Kentucky, United States, 40536
Contact: Site 1978            
Local Institution Not yet recruiting
Pikeville, Kentucky, United States, 41501
Contact: Site 1938            
United States, Louisiana
Cancer Center Of Acadiana Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Luis A Meza, Site 1909            
Local Institution Not yet recruiting
Shreveport, Louisiana, United States, 71103
Contact: Site 1960            
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Gary I Cohen, Site 1971            
Local Institution Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: Site 1956            
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 1912            
Reliant Medical Group, Inc Recruiting
Worcester, Massachusetts, United States, 01608
Contact: Tony M Samaha, Site 1907     508-368-3168        
United States, Michigan
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Site 1984            
United States, Minnesota
Local Institution Not yet recruiting
Robbinsville, Minnesota, United States, 55422
Contact: Site 1953            
United States, Missouri
Mercy Medical Research Institute Recruiting
Springfield, Missouri, United States, 65807
Contact: Viran Holden, Site 1902     417-820-8099        
Washington University School Of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ravi Vij, Site 1926            
United States, Nevada
Local Institution Not yet recruiting
Las Vegas, Nevada, United States, 89106
Contact: Site 1930            
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10065
Contact: Site 1910            
Local Institution Not yet recruiting
New York, New York, United States, 10019
Contact: Site 1933            
United States, North Carolina
Local Institution Not yet recruiting
Cary, North Carolina, United States, 27518
Contact: Site 1939            
Local Institution Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact: Site 1974            
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Site 1915            
United States, Pennsylvania
Local Institution Not yet recruiting
Baltimore, Pennsylvania, United States, 21229
Contact: Site 1943            
Local Institution Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Site 1969            
Local Institution Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site 7903            
Local Institution Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site 1987            
Local Institution Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site 7902            
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Site 1980            
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site 1973            
United States, South Carolina
Local Institution Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Site 1914            
Local Institution Not yet recruiting
Greenville, South Carolina, United States, 29615
Contact: Site 1957            
United States, Tennessee
Local Institution Not yet recruiting
Knoxville, Tennessee, United States, 37920
Contact: Site 1941            
United States, Texas
Local Institution Not yet recruiting
Corpus Christi, Texas, United States, 78412
Contact: Site 1947            
Local Institution Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Site 1981            
Local Institution Not yet recruiting
Dallas, Texas, United States, 75230
Contact: Site 1936            
Northwest Cancer Center Recruiting
Houston, Texas, United States, 77090
Contact: Laurent Gressot, Site 1955            
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 1985            
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 1967            
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 1954            
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 1946            
United States, Virginia
Local Institution Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Site 1982            
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98108
Contact: Site 1906            
United States, Wisconsin
Local Institution Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: Site 1913            
Canada, Nova Scotia
Local Institution Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 2902            
Canada, Quebec
Local Institution Not yet recruiting
Montral, Quebec, Canada, H3A 1A1
Contact: Site 2909            
France
Local Institution Recruiting
Grenoble Cedex 9, France, 38043
Contact: Site 4905            
Local Institution Recruiting
Le Mans, France, 72037
Contact: Site 4915            
Local Institution Recruiting
Lille Cedex, France, 59037
Contact: Site 4901            
Local Institution Not yet recruiting
Lyon, France, 69373
Contact: Site 4912            
Local Institution Recruiting
Nantes, France, 44093
Contact: Site 4904            
Local Institution Recruiting
Paris, France, 75571
Contact: Site 4902            
Local Institution Recruiting
Toulouse, France, 31059
Contact: Site 4908            
Local Institution Recruiting
Vandoeuvre Les Nancy, France, 54500
Contact: Site 4903            
Italy
Local Institution Recruiting
Milano, Parma, Italy, 20132
Contact: Site 4941            
Local Institution Recruiting
Roma, Parma, Italy, 00144
Contact: Site 4948            
Local Institution Recruiting
Ancona, Italy, 60126
Contact: Site 4947            
Local Institution Not yet recruiting
Bari, Italy, 70124
Contact: Site 4940            
Local Institution Recruiting
Bologna, Italy, 40138
Contact: Site 4950            
Local Institution Recruiting
Brescia, Italy, 25132
Contact: Site 4935            
Local Institution Recruiting
Firenze, Italy, 50139
Contact: Site 4930            
Local Institution Recruiting
Genova, Italy, 16132
Contact: Site 4939            
Local Institution Suspended
Milano, Italy, 20133
Local Institution Recruiting
Modena, Italy, 44124
Contact: Site 4933            
Local Institution Recruiting
Pescara, Italy, 65124
Contact: Site 4945            
Local Institution Recruiting
Ravenna, Italy, 48121
Contact: Site 4943            
Local Institution Recruiting
Rimini, Italy, 47014
Contact: Site 4944            
Local Institution Recruiting
Rimini, Italy, 47900
Contact: Site 4949            
Local Institution Recruiting
Roma, Italy, 00168
Contact: Site 4931            
Local Institution Recruiting
Roma, Italy, 00161
Contact: Site 4946            
Local Institution Recruiting
Rome, Italy, 00144
Contact: Site 4942            
Local Institution Recruiting
Torino, Italy, 10126
Contact: Site 4934            
Puerto Rico
Local Institution Not yet recruiting
Ponce, Puerto Rico, 00716
Contact: Site 7901            
Spain
Local Institution Recruiting
Barcelona, Spain, 08003
Contact: Site 4969            
Local Institution Recruiting
Madrid, Spain, 28006
Contact: Site 4961            
Local Institution Recruiting
Murcia, Spain, 30008
Contact: Site 4970            
Local Institution Recruiting
Salamanca, Spain, 37007
Contact: Site 4966            
Local Institution Recruiting
Santiago Compostela, Spain, 15706
Contact: Site 4965            
Local Institution Recruiting
Toledo, Spain, 45004
Contact: Site 4962            
Local Institution Recruiting
Valencia, Spain, 46026
Contact: Site 4963            
Local Institution Recruiting
Valencia, Spain, 46010
Contact: Site 4967            
Local Institution Recruiting
Zaragoza, Spain, 50009
Contact: Site 4964            
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01478048     History of Changes
Other Study ID Numbers: CA204-009, 2011-002695-16
Study First Received: November 2, 2011
Last Updated: January 4, 2013
Health Authority: United States: Food and Drug Administration
Italy: Ministry of Health
Italy: National Bioethics Committee
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines

Keywords provided by Bristol-Myers Squibb:
Relapsed/Refractory Multiple Myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
 Dexamethasone
Dexamethasone 21-phosphate
Bortezomib
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 16, 2013