An Investigational Immuno-therapy Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
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| ClinicalTrials.gov Identifier: NCT02654132 |
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Recruitment Status :
Completed
First Posted : January 13, 2016
Results First Posted : June 3, 2019
Last Update Posted : November 1, 2022
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Sponsor:
Bristol-Myers Squibb
Collaborators:
Celgene
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Multiple Myeloma |
| Interventions |
Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone |
| Enrollment | 117 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 117 participants were randomized, and 115 participants were treated. |
| Arm/Group Title | E-Pd Cohort | Pd Cohort |
|---|---|---|
 Arm/Group Description |
Elotuzumab + Pomalidomide + Dexamethasone | Pomalidomide + Dexamethasone |
| Period Title: Pre-Treatment Period | ||
| Started [1] | 60 | 57 |
| Completed [2] | 60 | 55 |
| Not Completed | 0 | 2 |
| Reason Not Completed | ||
| Participant Withdrew Consent | 0 | 2 |
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[1]
Started = Randomized
[2]
Completed = Continued into Treatment Period
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| Period Title: Treatment Period | ||
| Started | 60 | 55 |
| Completed | 0 | 0 |
| Not Completed | 60 | 55 |
| Reason Not Completed | ||
| Disease progression | 43 | 38 |
| Adverse Event unrelated to study drug | 6 | 9 |
| Other reasons | 4 | 2 |
| Study drug toxicity | 2 | 2 |
| Withdrawal by Subject | 2 | 1 |
| Maximum Clinical Benefit | 0 | 2 |
| Participant request to discontinue | 2 | 0 |
| Administrative reasons by sponsor | 0 | 1 |
| Death | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | E-Pd Cohort | Pd Cohort | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Elotuzumab + Pomalidomide + Dexamethasone | Pomalidomide + Dexamethasone | Total of all reporting groups | |
| Overall Number of Baseline Participants | 60 | 57 | 117 | |
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Baseline Analysis Population Description |
All randomized participants
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 60 participants | 57 participants | 117 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
22 36.7%
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22 38.6%
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44 37.6%
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| >=65 years |
38 63.3%
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35 61.4%
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73 62.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 60 participants | 57 participants | 117 participants | |
| 66.2 (9.92) | 65.5 (9.95) | 65.9 (9.90) | ||
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 60 participants | 57 participants | 117 participants | |
| Female |
28 46.7%
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22 38.6%
|
50 42.7%
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| Male |
32 53.3%
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35 61.4%
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67 57.3%
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[1]
Measure Analysis Population Description: All treated participants
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 60 participants | 57 participants | 117 participants | |
| Hispanic or Latino |
1 1.7%
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0 0.0%
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1 0.9%
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| Not Hispanic or Latino |
10 16.7%
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18 31.6%
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28 23.9%
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| Unknown or Not Reported |
49 81.7%
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39 68.4%
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88 75.2%
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Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 60 participants | 57 participants | 117 participants | |
| White |
45 75.0%
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45 78.9%
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90 76.9%
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| Black or African American |
0 0.0%
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1 1.8%
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1 0.9%
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| Asian |
15 25.0%
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9 15.8%
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24 20.5%
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| Other |
0 0.0%
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2 3.5%
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2 1.7%
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[1]
Measure Analysis Population Description: All treated participants
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
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 |
| Phone: | Please email |
| EMail: | Clinical.Trials@bms.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02654132 |
| Other Study ID Numbers: |
CA204-125 2014-003282-19 ( EudraCT Number ) |
| First Submitted: | December 31, 2015 |
| First Posted: | January 13, 2016 |
| Results First Submitted: | January 17, 2019 |
| Results First Posted: | June 3, 2019 |
| Last Update Posted: | November 1, 2022 |