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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: June 25, 2014
Last verified: October 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: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (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

For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478048

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Hide Study Locations
Locations
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         
Usc Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Ann Mohrbacher, Site 1927    323-865-0371      
Ucla Department Of Medicine Recruiting
Los Angeles, California, United States, 90095
Contact: Gary Schiller, Site 1928    310-206-5755      
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    858-939-5052      
Kaiser Permanente Medical Center Recruiting
Vallejo, California, United States, 94589
Contact: Tatjana Kolevska, Site 1958    707-651-2878      
Local Institution Not yet recruiting
Vallejo, California, United States, 94589
Contact: Site 1989         
United States, Florida
Cancer Specialists Of North Florida Beaches Recruiting
Jacksonville, Florida, United States, 32256
Contact: Mehdi M Moezi, Site 1904    904-538-4488      
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Jose Lutzky, Site 1917    305-674-2625      
Palm Beach Cancer Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Shachar Peles, Site 1919    561-472-1278      
United States, Hawaii
Kaiser Permanente-Moanalua Medical Center Recruiting
Honolulu, Hawaii, United States, 96819
Contact: Jennifer F Carney, Site 1972    808-432-5555      
United States, Illinois
University Of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Andrzej Jakubowiak, Site 1944    773-702-1982      
Local Institution Not yet recruiting
Decatur, Illinois, United States, 62526
Contact: Site 1965         
Oncology Specialists, S.C. Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Jacob Bitran, Site 1975    847-268-8200      
Local Institution Not yet recruiting
Urbana, Illinois, United States, 61801
Contact: Site 1983         
United States, Indiana
Investigative Clinical Research Of Indiana, Llc Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Robert Manges, Site 1921    317-297-2208      
United States, Kentucky
Local Institution Not yet recruiting
Hazard, Kentucky, United States, 41701
Contact: Site 1929         
University Of Kentucky Markey Cancer Center Suspended
Lexington, Kentucky, United States, 40536
United States, Louisiana
Cancer Center Of Acadiana Recruiting
Lafayette, Louisiana, United States, 70503
Contact: Victoria Panelli, Site 1909    337-289-8658      
Local Institution Not yet recruiting
Shreveport, Louisiana, United States, 71101
Contact: Site 1987         
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21204
Contact: Site 1971         
United States, Massachusetts
Dana Faber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jacob Laubach, Site 1912    617-632-6319      
Local Institution Not yet recruiting
Worcester, Massachusetts, United States, 01608
Contact: Site 1907         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Vrushali Dabak, Site 1984    313-916-9249      
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ravi Vij, Site 1926    314-454-8302      
Mercy Medical Research Institute Recruiting
Springfield, Missouri, United States, 65807
Contact: Viran Roger Holden, Site 1902    417-820-4587      
United States, Nevada
Southern Nevada Cancer Research Foundation Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A Ellerton, Site 1930    702-384-0013      
United States, North Carolina
Waverly Hematology Oncology Suspended
Cary, North Carolina, United States, 27518
United States, Pennsylvania
St. Agnes Hospital Suspended
Baltimore, Pennsylvania, United States, 21229
Cancer Care Associates Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Yacoub Faroun, Site 1969    484-526-5190      
Penn State Hershey Cancer Institute Suspended
Hershey, Pennsylvania, United States, 17033
Penn State Hershey Cancer Inst Suspended
Hershey, Pennsylvania, United States, 17033
The Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Entezam A Sahovic, Site 1973    412-578-4415      
United States, South Carolina
Medical University Of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Robert Stuart, Site 1914    843-792-6968      
Local Institution Not yet recruiting
Greenville, South Carolina, United States, 29615
Contact: Site 1957         
United States, Texas
Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Joseph Fay, Site 1981    214-820-1530      
Northwest Cancer Center Recruiting
Houston, Texas, United States, 77090
Contact: Laurent Gressot, Site 1955    281-440-5006      
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         
Canada, Nova Scotia
Local Institution Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Site 2902         
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
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 Not yet 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, 25123
Contact: Site 4935         
Local Institution Recruiting
Firenze, Italy, 50139
Contact: Site 4930         
Local Institution Recruiting
Genova, Italy, 16132
Contact: Site 4939         
Local Institution Not yet recruiting
Lecce, Italy, 73100
Contact: Site 4937         
Local Institution Recruiting
Modena, Italy, 41124
Contact: Site 4933         
Local Institution Recruiting
Pescara, Italy, 65124
Contact: Site 4945         
Local Institution Recruiting
Ravenna, Italy, 48121
Contact: Site 4943         
Local Institution Not yet recruiting
Rimini, Italy, 47900
Contact: Site 4949         
Local Institution Recruiting
Rimini, Italy, 47014
Contact: Site 4944         
Local Institution Not yet recruiting
Roma, Italy, 00168
Contact: Site 4931         
Local Institution Recruiting
Roma, Italy, 161
Contact: Site 4946         
Local Institution Recruiting
Rome, Italy, 00144
Contact: Site 4942         
Local Institution Recruiting
Torino, Italy, 10126
Contact: Site 4934         
Spain
Local Institution Recruiting
Barcelona, Spain, 08003
Contact: Site 4969         
Local Institution Recruiting
Madrid, Spain, 28006
Contact: Site 4961         
Local Institution Not yet 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, 46010
Contact: Site 4967         
Local Institution Recruiting
Valencia, Spain, 46026
Contact: Site 4963         
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: June 25, 2014
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 August 01, 2014