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

Primary Purpose

Lymphoma, Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Dexamethasone
Dexamethasone (Oral)
Dexamethasone (IV)
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 Lymphoma

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:

  • Documented progression from most recent line of therapy
  • 1-3 prior lines of therapy
  • Measurable disease
  • Life expectancy ≥3 months

  • Prior treatment with Lenalidomide permitted if:

    1. Best response achieved was ≥Partial Response (PR)
    2. Patient was not refractory
    3. Patient did not discontinue due to a Grade ≥3 related adverse event
    4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Exclusion Criteria:

  • Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma
  • Active plasma cell leukemia
  • Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C

Sites / Locations

  • Northwest Alabama Cancer Center, Pc
  • Acrc/Arizona Clinical Research Center, Inc.
  • Local Institution
  • Local Institution
  • Compassionate Cancer Res Grp
  • Local Institution
  • San Diego Pacific Oncology& Hematology Associates, Inc
  • Local Institution
  • Ucla-Division Of Hematology/Oncology
  • Medical Oncology Care Associates
  • Sharp Clinical Oncology Research
  • Local Institution
  • Local Institution
  • Cancer Care Centers Of Florida
  • Mount Sinai Comprehensive Cancer Center
  • Local Institution
  • Cancer Institute Of Florida
  • Local Institution
  • Florida Cancer Specialists
  • Winship Cancer Institute.
  • Georgia Health Science University
  • Orchard Healthcare Research Inc.
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Pikeville Medical Center
  • Cancer Center Of Acadiana At Lafayette General
  • Local Institution
  • Local Institution
  • Willis Knighton Cancer Center
  • Dana Farber Cancer Inst
  • Dana-Farber Cancer Institute
  • Henry Ford Health System
  • Capitol Comprehensive Cancer Care Center
  • Washington University School Of Medicine
  • Local Institution
  • Local Institution
  • NYU Clinical Cancer Center
  • Local Institution
  • Weill Cornell Medical College
  • Local Institution
  • Levine Cancer Institute
  • Gaston Hematology & Oncology
  • Local Institution
  • University Of Oklahoma Health Sciences Center
  • Local Institution
  • Local Institution
  • Western Pennsylvania Hospital
  • Local Institution
  • Local Institution
  • Local Institution
  • The West Clinic
  • Cancer Specialists Of South Texas, Pa
  • Ut Southwestern Medical Center
  • University Of Texas Md Anderson Cancer Ctr
  • Northwest Cancer Center
  • Hematology-Oncology Associates Of Fredricksburg, Inc
  • Va Puget Sound Health Care System
  • Gundersen Clinic, Ltd
  • University Of Wisconsin Hospital And Clinics
  • Medical College of Wisconsin
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
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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

Median Progression Free Survival (PFS)
Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Objective Response Rate (ORR)
Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.

Secondary Outcome Measures

Median Overall Survival (OS)
Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
Change From Baseline of Mean Score Pain Severity (BPI-SF)
The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Change From Baseline of Mean Score Pain Interference (BPI-SF)
The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

Full Information

First Posted
November 8, 2010
Last Updated
May 5, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT01239797
Brief Title
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Acronym
ELOQUENT - 2
Official Title
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 20, 2011 (Actual)
Primary Completion Date
September 2, 2014 (Actual)
Study Completion Date
April 21, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
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
Lymphoma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
646 (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 (Oral)
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention Type
Drug
Intervention Name(s)
Dexamethasone (IV)
Other Intervention Name(s)
Decadron®, Dexamethasone Intensol®, Dexpak®, Taperpak®
Intervention Description
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 subject meets criteria for discontinuation of study drug
Intervention Type
Biological
Intervention Name(s)
Elotuzumab (BMS-901608; HuLuc63)
Intervention Description
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 subject meets criteria for discontinuation of study drug
Primary Outcome Measure Information:
Title
Median Progression Free Survival (PFS)
Description
Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
Time Frame
From randomization up to 326 events (up to approximately 38 months)
Title
Objective Response Rate (ORR)
Description
Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
Time Frame
From randomization up to approximately 38 months
Secondary Outcome Measure Information:
Title
Median Overall Survival (OS)
Description
Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
Time Frame
Randomization to the date of death from any cause (up to approximately 9 years)
Title
Change From Baseline of Mean Score Pain Severity (BPI-SF)
Description
The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Time Frame
From baseline up to approximately 38 months
Title
Change From Baseline of Mean Score Pain Interference (BPI-SF)
Description
The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
Time Frame
From baseline up to approximately 38 months

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: Documented progression from most recent line of therapy 1-3 prior lines of therapy Measurable disease Life expectancy ≥3 months Prior treatment with Lenalidomide permitted if: Best response achieved was ≥Partial Response (PR) Patient was not refractory Patient did not discontinue due to a Grade ≥3 related adverse event Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression Exclusion Criteria: Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma 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
Northwest Alabama Cancer Center, Pc
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35661
Country
United States
Facility Name
Acrc/Arizona Clinical Research Center, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Local Institution
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Local Institution
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Compassionate Cancer Res Grp
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Local Institution
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
San Diego Pacific Oncology& Hematology Associates, Inc
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Local Institution
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Ucla-Division Of Hematology/Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Medical Oncology Care Associates
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Local Institution
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Local Institution
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Cancer Care Centers Of Florida
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Local Institution
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Cancer Institute Of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Local Institution
City
Titusville
State/Province
Florida
ZIP/Postal Code
32796
Country
United States
Facility Name
Florida Cancer Specialists
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Winship Cancer Institute.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Health Science University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Orchard Healthcare Research Inc.
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Local Institution
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Local Institution
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
Facility Name
Local Institution
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Pikeville Medical Center
City
Pikeville
State/Province
Kentucky
ZIP/Postal Code
41501
Country
United States
Facility Name
Cancer Center Of Acadiana At Lafayette General
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Local Institution
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Local Institution
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Willis Knighton Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Dana Farber Cancer Inst
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65101
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Local Institution
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Local Institution
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8151
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Gaston Hematology & Oncology
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Local Institution
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
University Of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Local Institution
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Local Institution
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Local Institution
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Cancer Specialists Of South Texas, Pa
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78412
Country
United States
Facility Name
Ut Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8565
Country
United States
Facility Name
University Of Texas Md Anderson Cancer Ctr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northwest Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Hematology-Oncology Associates Of Fredricksburg, Inc
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22408
Country
United States
Facility Name
Va Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Gundersen Clinic, Ltd
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University Of Wisconsin Hospital And Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Local Institution
City
Canberra
State/Province
New South Wales
ZIP/Postal Code
2605
Country
Australia
Facility Name
Local Institution
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Local Institution
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Local Institution
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1220
Country
Austria
Facility Name
Local Institution
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Brussles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Edegem-antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Local Institution
City
Barrie
ZIP/Postal Code
L4M 6M2
Country
Canada
Facility Name
Local Institution
City
Montreal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Local Institution
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Local Institution
City
Clamart Cedex
ZIP/Postal Code
92140
Country
France
Facility Name
Local Institution
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Local Institution
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris 12
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution
City
Pierre Benita
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Tours Cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Local Institution
City
Vandoeuvre
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Local Institution
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Local Institution
City
Hamm
ZIP/Postal Code
59071
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution
City
Munchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Local Institution
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Local Institution
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Local Institution
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Local Institution
City
Gyor
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Local Institution
City
Szeged
ZIP/Postal Code
H-6725
Country
Hungary
Facility Name
Local Institution
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Local Institution
City
Tullamore
Country
Ireland
Facility Name
Local Institution
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Local Institution
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Local Institution
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Local Institution
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Local Institution
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Local Institution
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4600001
Country
Japan
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution
City
Maebashi-shi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
Facility Name
Local Institution
City
Shibukawa-shi
State/Province
Gunma
ZIP/Postal Code
3770280
Country
Japan
Facility Name
Local Institution
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
0608543
Country
Japan
Facility Name
Local Institution
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
980-8754
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5438555
Country
Japan
Facility Name
Local Institution
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
1138677
Country
Japan
Facility Name
Local Institution
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Facility Name
Local Institution
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
1508935
Country
Japan
Facility Name
Local Institution
City
Shinjuuku-ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution
City
Kamogawa
State/Province
Toyko
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Local Institution
City
Chiba-shi
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Local Institution
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Local Institution
City
Niigata
ZIP/Postal Code
9518566
Country
Japan
Facility Name
Local Institution
City
Okayama
ZIP/Postal Code
7011192
Country
Japan
Facility Name
Local Institution
City
Toyohashi-shi
ZIP/Postal Code
4418570
Country
Japan
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Local Institution
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Local Institution
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Local Institution
City
Brasov
ZIP/Postal Code
700106
Country
Romania
Facility Name
Local Institution
City
Bucaresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
22328
Country
Romania
Facility Name
Local Institution
City
Badalona-Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Local Institution
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Local Institution
City
Santiago De Comp-coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Toledo
ZIP/Postal Code
45004
Country
Spain
Facility Name
Local Institution
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution
City
Geneve 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Local Institution
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution
City
Istanbul
State/Province
Capa
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Local Institution
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Local Institution
City
Izmir
ZIP/Postal Code
35330
Country
Turkey
Facility Name
Local Institution
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Arab Emirates
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Airdrie
State/Province
Lancashire
ZIP/Postal Code
ML6 OJS
Country
United Kingdom
Facility Name
Local Institution
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Local Institution
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution
City
Leeds
ZIP/Postal Code
LS9 7FT
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30204239
Citation
Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.
Results Reference
derived
PubMed Identifier
28070715
Citation
Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.
Results Reference
derived
PubMed Identifier
26035255
Citation
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, Rollig 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.
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 Relapsed or Refractory Multiple Myeloma

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