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

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ClinicalTrials.gov Identifier: NCT01478048
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : January 26, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Biological: Elotuzumab
Drug: Bortezomib
Drug: Dexamethasone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
185 participants were enrolled, 152 participants were randomized. Reasons not randomized: 23 no longer met study criteria, 5 withdrew consent, 2 died, 3 had poor/non-compliance. 150 were treated with study drug. 2 participants were not treated: 1 withdrawal by subject and 1 physician decision.

Reporting Groups
  Description
Elotuzumab + Bortezomib + Dexamethasone 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 participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 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 criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of 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 criteria met for discontinuation
Bortezomib + Dexamethasone Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 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 criteria is met for discontinuation of study drug

Participant Flow:   Overall Study
    Elotuzumab + Bortezomib + Dexamethasone   Bortezomib + Dexamethasone
STARTED   77   75 
Received Treatment   76 [1]   74 [1] 
COMPLETED [2]   0   0 
NOT COMPLETED   77   75 
Disease Progression                52                35 
study drug toxicity                11                14 
Adverse Event                2                11 
subject request to discontinue treatment                3                5 
Withdrawal by Subject                2                5 
non-specified                6                4 
poor/non-compliance                0                1 
no longer meets study criteria                1                0 
[1] 1 randomized to E-Bd but received Bd. Included in E-Bd group for efficacy and Bd group for safety
[2] Completed = Still on treatment



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants who were randomized to a treatment arm were summarized.

Reporting Groups
  Description
Elotuzumab + Bortezomib + Dexamethasone 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 participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 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 criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of 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 criteria met for discontinuation
Bortezomib + Dexamethasone Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 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 criteria is met for discontinuation of study drug
Total Total of all reporting groups

Baseline Measures
   Elotuzumab + Bortezomib + Dexamethasone   Bortezomib + Dexamethasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 77   75   152 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.4  (9.48)   65.1  (10.34)   65.3  (9.88) 
Age, Customized [1] 
[Units: Participants]
Count of Participants
     
< 65 years   34   33   67 
≥65 and <75 years   28   28   56 
>= 75 years   15   14   29 
[1] Less than (<); Greater than, equal to (≥).
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      35  45.5%      38  50.7%      73  48.0% 
Male      42  54.5%      37  49.3%      79  52.0% 
Region of Enrollment [1] 
[Units: Participants]
Count of Participants
     
United States   25   23   48 
Italy   34   32   66 
France   10   11   21 
Spain   8   9   17 
[1] Number of participants enrolled, by country, were summarized.
Prior Protease Inhibitor Use [1] 
[Units: Participants]
Count of Participants
     
Yes   38   37   75 
No   39   38   77 
[1] Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
Presence of At Least 1 FcγRIIIa V allele [1] 
[Units: Participants]
Count of Participants
     
Yes   55   54   109 
No   22   21   43 
[1] An allele is any one of a series of 2 or more different genes that may be on a specific chromosome. Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
Number of Prior Lines of Therapy [1] 
[Units: Participants]
Count of Participants
     
1 line of prior therapy   55   51   106 
2 or 3 lines of prior therapy   22   24   46 
[1] Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.


  Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   1 Year Progression-Free Survival Rate - Randomized Participants   [ Time Frame: Year 1 after last participant was randomized ]

4.  Secondary:   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 ]

5.  Secondary:   Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants   [ Time Frame: Randomization until 111 events, up to May 2014, approximately 2 years ]

6.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01478048     History of Changes
Other Study ID Numbers: CA204-009
2011-002695-16 ( EudraCT Number )
First Submitted: November 2, 2011
First Posted: November 23, 2011
Results First Submitted: December 17, 2015
Results First Posted: January 26, 2016
Last Update Posted: May 21, 2018