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

April 20, 2018 updated by: Bristol-Myers Squibb

A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Local Institution
      • Grenoble Cedex 9, France, 38043
        • Local Institution
      • Le Mans, France, 72037
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Nantes, France, 44093
        • Local Institution
      • Paris 12, France, 75012
        • Local Institution
      • Toulouse, France, 31059
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54500
        • Local Institution
      • Ancona, Italy, 60126
        • Local Institution
      • Bari, Italy, 70124
        • Local Institution
      • Bologna, Italy, 40138
        • Local Institution
      • Brescia, Italy, 25123
        • Local Institution
      • Firenze, Italy, 50134
        • Local Institution
      • Genova, Italy, 16132
        • Local Institution
      • Lecce, Italy, 73100
        • Local Institution
      • Meldola (fc), Italy, 47014
        • Local Institution
      • Modena, Italy, 41124
        • Local Institution
      • Pescara, Italy, 65124
        • Local Institution
      • Ravenna, Italy, 48100
        • Local Institution
      • Rimini, Italy, 47900
        • Local Institution
      • Roma, Italy, 00168
        • Local Institution
      • Roma, Italy, 161
        • Local Institution
      • Rome, Italy, 00144
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
    • Parma
      • Milano, Parma, Italy, 20132
        • Local Institution
      • Roma, Parma, Italy, 00144
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Madrid, Spain, 28006
        • Local Institution
      • Murcia, Spain, 30008
        • Local Institution
      • Salamanca, Spain, 37007
        • Local Institution
      • Santiago Compostela, Spain, 15706
        • Local Institution
      • Toledo, Spain, 45004
        • Local Institution
      • Valencia, Spain, 46026
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
      • Zaragoza, Spain, 50009
        • Local Institution
    • California
      • Corona, California, United States, 92879
        • Compassionate Cancer Res Grp
      • Corona, California, United States, 92879
        • Local Institution
      • Long Beach, California, United States, 90806
        • Local Institution
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA Department of Medicine
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • San Diego, California, United States, 92123
        • Sharp Clinical Oncology Research
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Center
      • Vallejo, California, United States, 94589
        • Local Institution
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North FL
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente-Moanalua Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Decatur, Illinois, United States, 62526
        • Local Institution
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, S.C.
      • Urbana, Illinois, United States, 61801
        • Local Institution
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Investigative Clinical Research of Indiana, LLC
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Local Institution
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Markey Cancer Center
      • Pikeville, Kentucky, United States, 41501
        • Pikeville Medical Center Leonard Lawson Cancer Center
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Cancer Center of Acadiana
      • Shreveport, Louisiana, United States, 71101
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01608
        • Local Institution
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, United States, 65807
        • Mercy Medical Research Institute
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Southern Nevada Cancer Research Foundation
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Waverly Hematology Oncology
    • Pennsylvania
      • Baltimore, Pennsylvania, United States, 21229
        • St. Agnes Hospital
      • Bethlehem, Pennsylvania, United States, 18015
        • Cancer Care Associates
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Cancer Institute
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Cancer Inst
      • Pittsburgh, Pennsylvania, United States, 15224
        • The Western Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29615
        • Local Institution
    • Texas
      • Dallas, Texas, United States, 75246
        • Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77090
        • Northwest Cancer Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Local Institution
    • Washington
      • Seattle, Washington, United States, 98108
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • BMS-901608
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 Names:
  • Velcade®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
Active Comparator: Arm B: Bortezomib + Dexamethasone
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 Names:
  • Velcade®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®
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®
  • Dexpak®
  • Taperpak®
  • Intensol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants
Time Frame: Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years
PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years
Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants
Time Frame: Randomization until 111 events, up to May 2014, approximately 2 years
PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.
Randomization until 111 events, up to May 2014, approximately 2 years
1 Year Progression-Free Survival Rate - Randomized Participants
Time Frame: Year 1 after last participant was randomized
PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.
Year 1 after last participant was randomized

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele
Time Frame: Randomization until 111 events, up to May 2014, approximately 2 years
PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.
Randomization until 111 events, up to May 2014, approximately 2 years
Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants
Time Frame: Randomization until 111 events, up to May 2014, approximately 2 years
ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.
Randomization until 111 events, up to May 2014, approximately 2 years
Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele
Time Frame: Randomization until 111 events, up to May 2014, approximately 2 years
ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.
Randomization until 111 events, up to May 2014, approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2011

Primary Completion (Actual)

May 30, 2014

Study Completion (Actual)

April 21, 2017

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

April 20, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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