Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (ELOQUENT - 2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01239797
First received: November 8, 2010
Last updated: January 4, 2017
Last verified: January 2017
Results First Received: August 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma (Myeloma)
Multiple Myeloma
Interventions: Drug: Lenalidomide
Drug: Dexamethasone
Drug: Dexamethasone (Oral)
Drug: Dexamethasone (IV)
Biological: Elotuzumab (BMS-901608; HuLuc63)

  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
Study initiated: June 2011; Study Completion: Study on-going

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
761 participants were enrolled and 646 participants were randomized (321 Lenalidomide with Elotuzumab, E-Ld and 325 Lenalidomide, Ld). 635 were treated (318 Lenalidomide with Elotuzumab, E-Ld and 317 Lenalidomide, Ld). Reason for non-treatment include 11 non-specified reasons.

Reporting Groups
  Description
Lenalidomide + Dexamethasone + Elotuzumab

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug

Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide + Dexamethasone

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug


Participant Flow for 2 periods

Period 1:   Randomized Participants
    Lenalidomide + Dexamethasone + Elotuzumab   Lenalidomide + Dexamethasone
STARTED   321   325 
COMPLETED   319   316 
NOT COMPLETED   2   9 

Period 2:   Treated Participants
    Lenalidomide + Dexamethasone + Elotuzumab   Lenalidomide + Dexamethasone
STARTED   318 [1]   317 [1] 
COMPLETED   83 [2]   43 [2] 
NOT COMPLETED   235   274 
Disease Progression                153                161 
Study Drug Toxicity                30                44 
Adverse Event Unrelated to Study Drug                22                32 
Withdrawal by Subject                27                23 
Non-specified                1                11 
Death                1                1 
Subject No Longer Meets Study Criteria                1                1 
Poor/Non-compliance                0                1 
[1] 1 participant was randomized to treatment E-Ld but received treatment Ld
[2] Completed = Still on Treatment



  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.
Randomized: all participants randomized to any treatment group

Reporting Groups
  Description
Lenalidomide + Dexamethasone + Elotuzumab

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (Oral):

On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone (IV):

On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug

Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

Lenalidomide + Dexamethasone

Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

Total Total of all reporting groups

Baseline Measures
   Lenalidomide + Dexamethasone + Elotuzumab   Lenalidomide + Dexamethasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 321   325   646 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.2  (9.34)   65.3  (10.26)   65.7  (9.81) 
Age, Customized 
[Units: Participants]
     
< 65 years old   134   142   276 
>= 65 and < 75 years old   119   122   241 
>= 75 years old   68   61   129 
Gender 
[Units: Participants]
Count of Participants
     
Female      129  40.2%      132  40.6%      261  40.4% 
Male      192  59.8%      193  59.4%      385  59.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      5   1.6%      1   0.3%      6   0.9% 
Not Hispanic or Latino      28   8.7%      33  10.2%      61   9.4% 
Unknown or Not Reported      288  89.7%      291  89.5%      579  89.6% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   264   280   544 
Black or African American   13   10   23 
American Indian or Alaska Native   0   0   0 
Asian   33   31   64 
Native Hawaiian or Other Pacific Islander   1   0   1 
Other   9   4   13 
Not Reported   1   0   1 


  Outcome Measures
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1.  Primary:   Median Progression Free Survival (PFS)   [ Time Frame: Randomization until 326 events (approximately 2 years) ]

2.  Primary:   Objective Response Rate (ORR)   [ Time Frame: Randomization to end of treatment (approximately 2 years) ]

3.  Secondary:   Median Overall Survival (OS)   [ Time Frame: Randomization to 427 deaths (approximately 7 years) ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  

4.  Secondary:   Change in Baseline of Brief Pain Inventory-Short Form (BPI-SF) Scores   [ Time Frame: Baseline to Study Completion (up to 7 years) ]
Results not yet reported.   Anticipated Reporting Date:   10/2019  


  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


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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01239797     History of Changes
Other Study ID Numbers: CA204-004
2010-020347-12 ( EudraCT Number )
Study First Received: November 8, 2010
Results First Received: August 4, 2016
Last Updated: January 4, 2017