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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Lymphoma; 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
Sex: Female, Male; [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) ]

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2. Primary:

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

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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

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  Other Adverse Events

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  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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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: 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. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

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):

Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Röllig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01239797 History of Changes
Other Study ID Numbers:	CA204-004; 2010-020347-12 ( EudraCT Number )
First Submitted:	November 8, 2010
First Posted:	November 11, 2010
Results First Submitted:	August 4, 2016
Results First Posted:	January 5, 2017
Last Update Posted:	September 26, 2017