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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)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Elotuzumab
Pomalidomide
Dexamethasone
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

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:

  • ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination
  • Documented refractory or relapsed and refractory multiple myeloma
  • Refractory to proteosome inhibitor and lenalidomide, and to last treatment
  • Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment
  • Measurable disease at screening
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • Active plasma cell leukemia
  • Prior treatment with pomalidomide
  • Unable to tolerate thromboembolic prophylaxis while on the study
  • Prior autologous stem cell transplant within 12 weeks
  • Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C

Sites / Locations

  • Winship Cancer Institute
  • Rush University Medical Center
  • Investigative Clinical Research Of Indiana, Llc
  • Beth Israel Comprehensive Cancer Center
  • Dana Farber Cancer Institute.
  • Rochester General Hospital
  • Carolinas Healthcare System
  • Va Pittsburgh Healthcare System
  • St Francis Hospital
  • Tennessee Cancer Specialists
  • Northern Utah Associates
  • University Of Washington
  • Local Institution
  • Local Institution
  • CISSS de l'Outaouais
  • Local Institution - 0048
  • Local Institution - 0022
  • Local Institution - 0021
  • Local Institution - 0020
  • Local Institution - 0019
  • Local Institution
  • Universitaetsklinikum Carl Gustav Carus
  • Universitaetsklinikum Freiburg
  • St. Barbara-Klinik
  • Local Institution - 0041
  • Local Institution - 0056
  • Klinikum Der Johannes Gutenberg Universitaet Mainz
  • Universitaetsklinikum Tuebingen
  • Laiko University Hospital
  • Alexandra General Hospital Of Athens
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
  • A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
  • Azienda Ospedaliera Universitaria Careggi
  • Local Institution
  • Universita' La Sapienza
  • Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
  • Local Institution - 0030
  • Local Institution - 0069
  • Local Institution - 0031
  • Local Institution - 0029
  • Local Institution - 0027
  • Local Institution - 0028
  • Local Institution - 0067
  • Local Institution - 0032
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
  • Local Institution
  • Oddzial Hematologii i Transplantacji Szpiku
  • Local Institution
  • Local Institution
  • Local Institution - 0024
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elotuzumab Arm

Control Arm

Arm Description

Biological:Elotuzumab (BMS-901608; HuLuc63) Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Subjects > 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak

Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects > 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: Decadron Dexamethasone Intensol Dexpak Taperpak

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 or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder

Secondary Outcome Measures

Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.
Overall Survival (OS)
OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.

Full Information

First Posted
December 31, 2015
Last Updated
October 5, 2022
Sponsor
Bristol-Myers Squibb
Collaborators
Celgene, AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02654132
Brief Title
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)
Official Title
An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 18, 2016 (Actual)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
October 21, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if adding Elotuzumab to Pomalidomide and low-dose dexamethasone is a more effective treatment of relapsed and refractory multiple myeloma compared to pomalidomide and low-dose dexamethasone by itself.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elotuzumab Arm
Arm Type
Experimental
Arm Description
Biological:Elotuzumab (BMS-901608; HuLuc63) Solution, Intravenous(IV),10 mg/kg(Cycles 1 and 2 weekly, on Days 1,8,15,22) Solution, Intravenous(IV),20 mg/kg(Cycle 3 and Beyond: Day 1) Drug: Pomalidomide •Capsules,Oral,4 mg,once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: •Tablets, Oral,28 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral,40 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Subjects > 75 years old: •Tablets, Oral,8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Solution, Intravenous(IV), 8 mg, once daily on: Days 1,8,15,22(Cycles 1&2) Day 1(Cycle 3 and Beyond) •Tablets, Oral, 20 mg, once daily on: Days 8,15,22(Cycle 3 and Beyond) Other Names: Decadron,Dexamethasone ,Intensol,Dexpak,Taperpak
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Drug: Pomalidomide • Capsules, Oral, 4 mg, once daily, on Days 1-21 Other Name: Pomalyst Drug: Dexamethasone Subjects ≤ 75 years old: • Tablets, Oral, 40 mg, weekly on Days 1, 8, 15 and 22 Subjects > 75 years old: • Tablets, Oral, 20 mg, weekly on Days 1, 8, 15 and 22, Other Names: Decadron Dexamethasone Intensol Dexpak Taperpak
Intervention Type
Drug
Intervention Name(s)
Elotuzumab
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Pomalyst
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
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 or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following: 1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder
Time Frame
From randomization to date of progression or death (up to approximately 21 months)
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour.
Time Frame
From first dose to disease progression (up to approximately 21 months)
Title
Overall Survival (OS)
Description
OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up.
Time Frame
From randomization to death (up to approximately 52 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: ≥ 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination Documented refractory or relapsed and refractory multiple myeloma Refractory to proteosome inhibitor and lenalidomide, and to last treatment Relapsed and refractory patients must have achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment Measurable disease at screening Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Exclusion Criteria: Active plasma cell leukemia Prior treatment with pomalidomide Unable to tolerate thromboembolic prophylaxis while on the study Prior autologous stem cell transplant within 12 weeks 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
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigative Clinical Research Of Indiana, Llc
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Beth Israel Comprehensive Cancer Center
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
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Carolinas Healthcare System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Va Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
St Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Northern Utah Associates
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
University Of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
CISSS de l'Outaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8P 7H2
Country
Canada
Facility Name
Local Institution - 0048
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution - 0022
City
Nantes Cedex 1
ZIP/Postal Code
44000
Country
France
Facility Name
Local Institution - 0021
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution - 0020
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 0019
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution
City
Saint Pierre Cedex
ZIP/Postal Code
97448
Country
France
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
St. Barbara-Klinik
City
Hamm
ZIP/Postal Code
59075
Country
Germany
Facility Name
Local Institution - 0041
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 0056
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum Der Johannes Gutenberg Universitaet Mainz
City
Mainz
ZIP/Postal Code
55101
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Laiko University Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Alexandra General Hospital Of Athens
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Ancona
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
A. O. U. Di Bologna, Policlinico S. Orsola Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Universita' La Sapienza
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Citta' Della Salute E Della Scienza Di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 0030
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution - 0069
City
Morioka-shi
State/Province
Iwate
ZIP/Postal Code
0208505
Country
Japan
Facility Name
Local Institution - 0031
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution - 0029
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Local Institution - 0027
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
1508935
Country
Japan
Facility Name
Local Institution - 0028
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
1900014
Country
Japan
Facility Name
Local Institution - 0067
City
Kasama-shi
ZIP/Postal Code
3091793
Country
Japan
Facility Name
Local Institution - 0032
City
Okayama
ZIP/Postal Code
701-1154
Country
Japan
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution
City
Maastrict
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Local Institution
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Oddzial Kliniczny Hematologii i Profilaktyki Chorob Nowotworowych
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Local Institution
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Oddzial Hematologii i Transplantacji Szpiku
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Local Institution
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution - 0024
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35960908
Citation
Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Yao D, Das P, San-Miguel J. Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. J Clin Oncol. 2023 Jan 20;41(3):568-578. doi: 10.1200/JCO.21.02815. Epub 2022 Aug 12.
Results Reference
derived
PubMed Identifier
30403938
Citation
Dimopoulos MA, Dytfeld D, Grosicki S, Moreau P, Takezako N, Hori M, Leleu X, LeBlanc R, Suzuki K, Raab MS, Richardson PG, Popa McKiver M, Jou YM, Shelat SG, Robbins M, Rafferty B, San-Miguel J. Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. N Engl J Med. 2018 Nov 8;379(19):1811-1822. doi: 10.1056/NEJMoa1805762.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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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