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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01478048
First received: November 2, 2011
Last updated: May 16, 2016
Last verified: January 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Biological: Elotuzumab
Drug: Bortezomib
Drug: Dexamethasone

  Participant Flow
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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. Study is on-going.

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     75     75  
COMPLETED     14 [1]   7 [1]
NOT COMPLETED     63     68  
Disease Progression                 46                 32  
study drug toxicity                 8                 13  
Adverse Event                 1                 9  
subject request to discontinue treatment                 1                 5  
Withdrawal by Subject                 2                 5  
non-specified                 1                 3  
poor/non-compliance                 1                 1  
no longer meets study criteria                 1                 0  
Not reported                 1                 0  
Physician Decision                 1                 0  
[1] completed=treatment on-going



  Baseline Characteristics
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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: 10 mg/kg Intravenous (IV): In Cycles 1 & 2: Treatment on Days 1, 8 & 15; In Cycles 3-8: on Days 1 & 11; In Cycle 9+: on Days 1 & 15.

Bortezomib: 1.3 mg/m^2 IV or subcutaneous; (Cycles 1 - 8: on Days 1, 4, 8, 11; Cycles 9+: on Days 1, 8, 15

Dexamethasone: On days of elotuzumab infusion, dexamethasone was administered as a split dose of 8mg oral 3 - 24 hours prior to elotuzumab followed by 8mg IV at least 45 minutes prior to elotuzumab. On other non-elotuzumab days, 20 mg oral dexamethasone was given once daily (QD) in Cycles 1 and 2 on Days 2, 4, 5, 9, 11; in Cycles 3 - 8 on Days 2, 4, 5, 8, 9, 12; in Cycles 9+ on Days 2, 8, 9, 16.

Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation.

Bortezomib + Dexamethasone

Bortezomib: 1.3 mg/m^2 IV; (Cycles 1 - 8 on Days 1, 4, 8, 11; Cycles 9+ on Days 1, 8, 15.

Dexamethasone: 20 mg oral; (Cycles 1-8 QD on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ QD on Days 1, 2, 8, 9, 15, 16).

Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation.

Total Total of all reporting groups

Baseline Measures
    Elotuzumab + Bortezomib + Dexamethasone     Bortezomib + Dexamethasone     Total  
Number of Participants  
[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]
     
< 65 years     34     33     67  
≥65 and <75 years     28     28     56  
>= 75 years     15     14     29  
Gender  
[units: participants]
     
Female     35     38     73  
Male     42     37     79  
Region of Enrollment [2]
[units: participants]
     
United States     25     23     48  
Italy     34     32     66  
France     10     11     21  
Spain     8     9     17  
Prior Protease Inhibitor Use [3]
[units: participants]
     
Yes     38     37     75  
No     39     38     77  
Presence of At Least 1 FcγRIIIa V allele [4]
[units: participants]
     
Yes     55     54     109  
No     22     21     43  
Number of Prior Lines of Therapy [3]
[units: participants]
     
1 line of prior therapy     55     51     106  
2 or 3 lines of prior therapy     22     24     46  
[1] Less than (<); Greater than, equal to (≥).
[2] Number of participants enrolled, by country, were summarized.
[3] Categories presented as they were at randomization.
[4] 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.



  Outcome Measures
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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
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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
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  More Information
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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



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01478048     History of Changes
Other Study ID Numbers: CA204-009
2011-002695-16 ( EudraCT Number )
Study First Received: November 2, 2011
Results First Received: December 17, 2015
Last Updated: May 16, 2016
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