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
  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:


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:
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 April 14, 2014