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Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Dexamethasone
Dexamethasone
Dexamethasone
Dexamethasone
Elotuzumab (BMS-901608; HuLuc63)
Elotuzumab (BMS-901608; HuLuc63)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Newly Diagnosed, Previously Untreated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

    • have not received any prior systemic anti-myeloma therapy AND
    • have measurable disease AND
    • are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

  • Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
  • Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
  • Monoclonal Gammopathy of Undetermined Significance (MGUS)
  • Active plasma cell leukemia
  • Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Sites / Locations

  • Local Institution - 1628
  • Local Institution - 7619
  • Local Institution - 7618
  • Local Institution - 7617
  • Local Institution - 1644
  • Local Institution - 1618
  • Local Institution - 1602
  • Local Institution - 1636
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  • Local Institution - 1648
  • Local Institution - 7613
  • Local Institution - 1623
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  • Local Institution - 1649
  • Local Institution - 1611
  • Local Institution - 1630
  • Local Institution - 1684
  • Local Institution - 1607
  • Local Institution - 1635
  • Local Institution - 1632
  • Local Institution - 7606
  • Local Institution - 7610
  • Local Institution - 1603
  • Local Institution - 7616
  • Local Institution - 7620
  • Local Institution - 1669
  • Local Institution - 1656
  • Local Institution - 1633
  • Local Institution - 1674
  • Local Institution - 1683
  • Local Institution - 1646
  • Local Institution - 7614
  • Local Institution - 1626
  • Local Institution - 1652
  • Local Institution - 1676
  • Local Institution - 1650
  • Local Institution - 1619
  • Local Institution - 1699
  • Local Institution - 1604
  • Local Institution - 1667
  • Local Institution - 1645
  • Local Institution - 1651
  • Local Institution - 1637
  • Local Institution - 7621
  • Local Institution - 1615
  • Local Institution - 1671
  • Local Institution - 7604
  • Local Institution - 1610
  • Local Institution - 1608
  • Local Institution - 1693
  • Local Institution - 1638
  • Local Institution - 1664
  • Local Institution - 1690
  • Local Institution - 1655
  • Local Institution - 7611
  • Local Institution - 1647
  • Local Institution - 1679
  • Local Institution - 1677
  • Local Institution - 1629
  • Local Institution - 7615
  • Local Institution - 1624
  • Local Institution - 7607
  • Local Institution - 1600
  • Local Institution - 7628
  • Local Institution - 1627
  • Local Institution - 1670
  • Local Institution - 1634
  • Local Institution - 7612
  • Local Institution - 1643
  • Local Institution - 1686
  • Local Institution - 1642
  • Local Institution - 7623
  • Local Institution - 1657
  • Local Institution - 1640
  • Local Institution - 1631
  • Local Institution - 1601
  • Gundersen Clinic, Ltd
  • Local Institution - 1663
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  • Local Institution - 3600
  • Local Institution - 3607
  • Local Institution - 3610
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  • Local Institution - 5252
  • Local Institution - 5254
  • Local Institution - 7626
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  • Local Institution - 5251
  • Local Institution - 7600
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  • Local Institution - 5551
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  • Local Institution - 5554
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  • Local Institution - 5550
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  • Local Institution - 5556
  • Local Institution - 5751
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  • Local Institution - 5951
  • Local Institution - 5953
  • Local Institution - 5950
  • Local Institution - 5954
  • Local Institution - 5952
  • Local Institution - 5955

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lenalidomide + Dexamethasone

Lenalidomide + Dexamethasone + Elotuzumab

Arm Description

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. Participants without any post-baseline tumor assessments were censored on the date of randomization

Secondary Outcome Measures

Objective Response Rate (ORR)
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
Overall Survival (OS)
Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
Progression Free Survival (PFS) Rate at Specific Time-points
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.

Full Information

First Posted
April 13, 2011
Last Updated
September 2, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT01335399
Brief Title
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Acronym
ELOQUENT - 1
Official Title
A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 4, 2011 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
September 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Newly Diagnosed, Previously Untreated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
748 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide + Dexamethasone
Arm Type
Active Comparator
Arm Title
Lenalidomide + Dexamethasone + Elotuzumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid®
Intervention Description
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Biological
Intervention Name(s)
Elotuzumab (BMS-901608; HuLuc63)
Intervention Description
Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Biological
Intervention Name(s)
Elotuzumab (BMS-901608; HuLuc63)
Intervention Description
Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. Participants without any post-baseline tumor assessments were censored on the date of randomization
Time Frame
From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
Time Frame
From randomization to primary completion date (approximately 8 years)
Title
Overall Survival (OS)
Description
Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
Time Frame
From randomization to the date of death (up to 8 years)
Title
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
Description
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
Time Frame
From Baseline to End of Treatment (approximately 8 years)
Title
Progression Free Survival (PFS) Rate at Specific Time-points
Description
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.
Time Frame
From randomization to the specified time-point (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who: have not received any prior systemic anti-myeloma therapy AND have measurable disease AND are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old Exclusion Criteria: Subjects with non-secretory or oligo-secretory or free light-chain only myeloma Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions Monoclonal Gammopathy of Undetermined Significance (MGUS) Active plasma cell leukemia Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 1628
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Local Institution - 7619
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Local Institution - 7618
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Local Institution - 7617
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Local Institution - 1644
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Local Institution - 1618
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Local Institution - 1602
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Local Institution - 1636
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Local Institution - 1668
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Local Institution - 1616
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Local Institution - 7609
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Local Institution - 1660
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Local Institution - 1673
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Institution - 1613
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution - 1621
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Local Institution - 1612
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Local Institution - 1682
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Local Institution - 1617
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Local Institution - 1648
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Local Institution - 7613
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Local Institution - 1623
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Local Institution - 1625
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Local Institution - 1649
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Local Institution - 1611
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Local Institution - 1630
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 1684
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Local Institution - 1607
City
Chicago
State/Province
Illinois
ZIP/Postal Code
19123
Country
United States
Facility Name
Local Institution - 1635
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Local Institution - 1632
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Local Institution - 7606
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Local Institution - 7610
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Local Institution - 1603
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Local Institution - 7616
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Local Institution - 7620
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Local Institution - 1669
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Local Institution - 1656
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Local Institution - 1633
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution - 1674
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Local Institution - 1683
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Local Institution - 1646
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Local Institution - 7614
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Local Institution - 1626
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Local Institution - 1652
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Local Institution - 1676
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Local Institution - 1650
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Local Institution - 1619
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 1699
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 1604
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Local Institution - 1667
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Local Institution - 1645
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution - 1651
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Local Institution - 1637
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Local Institution - 7621
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Local Institution - 1615
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Local Institution - 1671
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8183
Country
United States
Facility Name
Local Institution - 7604
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Local Institution - 1610
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Local Institution - 1608
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 1693
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 1638
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 1664
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
Local Institution - 1690
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Local Institution - 1655
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Local Institution - 7611
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Local Institution - 1647
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution - 1679
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Local Institution - 1677
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Local Institution - 1629
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution - 7615
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 1624
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Local Institution - 7607
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Local Institution - 1600
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Local Institution - 7628
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Local Institution - 1627
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 1670
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5505
Country
United States
Facility Name
Local Institution - 1634
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Local Institution - 7612
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 1643
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 1686
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 1642
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Local Institution - 7623
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Local Institution - 1657
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Local Institution - 1640
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Local Institution - 1631
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution - 1601
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Gundersen Clinic, Ltd
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Local Institution - 1663
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Local Institution - 1609
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Local Institution - 3600
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Local Institution - 3607
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Local Institution - 3610
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 3609
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Local Institution - 3608
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Local Institution - 3612
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution - 3606
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5001
Country
Australia
Facility Name
Local Institution - 3601
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Local Institution - 3602
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Local Institution - 3603
City
Heidelberg Melbourne
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 3604
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Local Institution - 3605
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 3611
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 4052
City
Fadingerstraße 1
ZIP/Postal Code
4020
Country
Austria
Facility Name
Local Institution - 4051
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution - 4054
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Local Institution - 4053
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution - 4160
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Local Institution - 4156
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 4157
City
Brussles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 4154
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Local Institution - 4159
City
Haine St Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
Local Institution - 4158
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 4150
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 4153
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Local Institution - 4151
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution - 2601
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution - 2600
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution - 2602
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Local Institution - 2611
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Local Institution - 2610
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Local Institution - 2606
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Local Institution - 2612
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution - 2603
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Local Institution - 2605
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution - 2607
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Local Institution - 4252
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution - 4250
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution - 4251
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution - 4565
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Local Institution - 4550
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Local Institution - 4555
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Local Institution - 4562
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 4552
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Local Institution - 4553
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 4560
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution - 4563
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 4554
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Local Institution - 4561
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution - 4558
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution - 4551
City
Offenbach
ZIP/Postal Code
63069
Country
Germany
Facility Name
Local Institution - 4556
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Local Institution - 4564
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 4559
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution - 4653
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 4651
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Local Institution - 4650
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Local Institution - 4652
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Local Institution - 4654
City
Patras
ZIP/Postal Code
26504
Country
Greece
Facility Name
Local Institution - 4751
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Local Institution - 4754
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Local Institution - 4750
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Local Institution - 4753
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Local Institution - 4752
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Local Institution - 4852
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Local Institution - 4850
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Local Institution - 4851
City
Galway
ZIP/Postal Code
0
Country
Ireland
Facility Name
Local Institution - 4950
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Local Institution - 4956
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Local Institution - 4960
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Local Institution - 4958
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution - 4951
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 4959
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Local Institution - 4954
City
Nahariya
ZIP/Postal Code
2210001
Country
Israel
Facility Name
Local Institution - 4952
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution - 4957
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 4955
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution - 5067
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Local Institution - 5065
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution - 5053
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution - 5070
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution - 5066
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution - 5050
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution - 5057
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution - 5075
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution - 5069
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Local Institution - 5052
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Local Institution - 5062
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 5068
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 5055
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Local Institution - 5063
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Local Institution - 5073
City
Reggio Nell Emilia (RE)
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution - 5064
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Local Institution - 5058
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution - 5054
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 5056
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 5072
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution - 5051
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 5250
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Local Institution - 5252
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Local Institution - 5254
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution - 7626
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Local Institution - 5258
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Local Institution - 5257
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Local Institution - 5259
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Local Institution - 5255
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Local Institution - 5256
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Local Institution - 5253
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Local Institution - 5260
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Local Institution - 5251
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Local Institution - 7600
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Local Institution - 7602
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Local Institution - 5356
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Local Institution - 5350
City
Bucaresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Local Institution - 5355
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Local Institution - 5353
City
Bucuresti
ZIP/Postal Code
050098
Country
Romania
Facility Name
Local Institution - 5352
City
Bucuresti
ZIP/Postal Code
22328
Country
Romania
Facility Name
Local Institution - 5351
City
Lasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
Local Institution - 5453
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Local Institution - 5450
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution - 5452
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution - 5552
City
Badalona-barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution - 5559
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 5555
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Local Institution - 5561
City
La Laguna- Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Local Institution - 5553
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Local Institution - 5551
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution - 5560
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution - 5554
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 5558
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 5550
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution - 5557
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Local Institution - 5556
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Local Institution - 5751
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution - 5750
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Local Institution - 5753
City
Zurich
ZIP/Postal Code
8028
Country
Switzerland
Facility Name
Local Institution - 5752
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 5853
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution - 5851
City
Ankara
State/Province
Dikimevi
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Local Institution - 5854
City
Izmir
State/Province
Inciralti
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Local Institution - 5856
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Local Institution - 5951
City
Belfast
State/Province
Antrim
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Local Institution - 5953
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution - 5950
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Local Institution - 5954
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Local Institution - 5952
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Local Institution - 5955
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35550060
Citation
Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

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