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History of Changes for Study: NCT02654132
Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma
Latest version (submitted October 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 12, 2016 None (earliest Version on record)
2 February 12, 2016 Study Status, Contacts/Locations and Study Design
3 February 25, 2016 Study Status
4 March 11, 2016 Study Status
5 March 28, 2016 Recruitment Status, Contacts/Locations, Sponsor/Collaborators and Study Status
6 April 12, 2016 Contacts/Locations and Study Status
7 April 21, 2016 Study Status and Study Identification
8 April 25, 2016 Contacts/Locations and Study Status
9 April 29, 2016 Study Status
10 May 10, 2016 Contacts/Locations and Study Status
11 May 25, 2016 Contacts/Locations and Study Status
12 June 9, 2016 Contacts/Locations and Study Status
13 June 17, 2016 Study Status, Study Identification and Study Design
14 June 24, 2016 Contacts/Locations, Study Design and Study Status
15 July 11, 2016 Contacts/Locations and Study Status
16 July 26, 2016 Contacts/Locations and Study Status
17 August 8, 2016 Contacts/Locations and Study Status
18 August 23, 2016 Contacts/Locations and Study Status
19 September 7, 2016 Study Status
20 September 23, 2016 Contacts/Locations and Study Status
21 October 7, 2016 Contacts/Locations and Study Status
22 October 26, 2016 Contacts/Locations and Study Status
23 November 8, 2016 Contacts/Locations and Study Status
24 November 30, 2016 Contacts/Locations and Study Status
25 December 6, 2016 Contacts/Locations and Study Status
26 December 23, 2016 Contacts/Locations and Study Status
27 January 5, 2017 Contacts/Locations and Study Status
28 January 9, 2017 Study Status
29 January 23, 2017 Contacts/Locations and Study Status
30 January 27, 2017 Study Status
31 February 16, 2017 Contacts/Locations and Study Status
32 February 22, 2017 Contacts/Locations, Study Status and References
33 March 2, 2017 Study Status
34 March 3, 2017 Contacts/Locations, References and Study Status
35 March 29, 2017 Contacts/Locations and Study Status
36 April 10, 2017 Study Status, Oversight, References, Contacts/Locations, Study Description and Study Identification
37 April 17, 2017 Study Status, References and Contacts/Locations
38 May 11, 2017 Recruitment Status, Study Status, Contacts/Locations and References
39 August 1, 2017 Study Status and Contacts/Locations
40 September 1, 2017 Study Status
41 September 14, 2017 Study Status
42 September 27, 2017 Study Status
43 October 17, 2017 Study Status
44 November 3, 2017 Study Status
45 November 13, 2017 Study Status
46 December 11, 2017 Study Status
47 February 2, 2018 Study Status and Study Design
48 February 15, 2018 Study Status
49 February 26, 2018 Study Status
50 April 23, 2018 Contacts/Locations and Study Status
51 June 5, 2018 Study Status and Contacts/Locations
52 August 27, 2018 References, Study Status and Contacts/Locations
53 September 10, 2018 Study Status
54 September 24, 2018 Study Status
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Results Submission Events
55 May 31, 2019 Study Status, Outcome Measures, Document Section, Results and Contacts/Locations
56 November 26, 2019 Study Status
57 December 10, 2019 Study Status
58 December 23, 2019 Study Status
59 March 16, 2020 Study Status
60 June 5, 2020 Study Status
61 June 16, 2020 Study Status
62 July 6, 2020 Study Status and Outcome Measures
63 January 11, 2022 Recruitment Status, Study Status and References
64 October 5, 2022 Outcome Measures, Adverse Events, Participant Flow, Baseline Characteristics, Contacts/Locations, References, Study Status, More Information and Study Design
Comparison Format:
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Study NCT02654132
Submitted Date:  May 10, 2016 (v10)
Open or close this module Study Identification
Unique Protocol ID: CA204-125
Brief Title: Trial of Pomalidomide and Low-dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma
Official Title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma
Secondary IDs: 2014-003282-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2016
Overall Status: Recruiting
Study Start: March 2016
Primary Completion: May 2017 [Anticipated]
Study Completion: November 2018 [Anticipated]
First Submitted: December 31, 2015
First Submitted that
Met QC Criteria:		 January 12, 2016
First Posted: January 13, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 10, 2016
Last Update Posted: May 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators: Celgene
AbbVie
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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 alone.
Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 121 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Elotuzumab Arm

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: ElotuzumabDrug: Pomalidomide
Other Names:
  • Pomalyst
Drug: Dexamethasone
Other Names:
  • Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
Active Comparator: Control Arm

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
 Drug: Pomalidomide
Other Names:
  • Pomalyst
Drug: Dexamethasone
Other Names:
  • Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival (PFS)
[ Time Frame: Approximately 14 months ]

PFS will be defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause
Secondary Outcome Measures:
1. Objective Response Rate (ORR)
[ Time Frame: Approximately 14 months ]
2. Overall Survival (OS)
[ Time Frame: Approximately 32 months ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email: Clinical.Trials@bms.com
Central Contact Backup: First line of the email MUST contain NCT# and Site #.
Study Officials: Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Locations: United States, Illinois
Local Institution
[Not yet recruiting]
Chicago, Illinois, United States, 60612
Contact:Contact: Site 0053
United States, Indiana
Investigative Clinical Research Of Indiana, Llc
[Recruiting]
Indianapolis, Indiana, United States, 46260
Contact:Contact: Robert Manges, Site 0039 317-716-0323
United States, Massachusetts
Local Institution
[Not yet recruiting]
Boston, Massachusetts, United States, 02215
Contact:Contact: Site 0051
United States, New York
Local Institution
[Not yet recruiting]
Rochester, New York, United States, 14621
Contact:Contact: Site 0055
United States, North Carolina
Local Institution
[Not yet recruiting]
Charlotte, North Carolina, United States, 28204
Contact:Contact: Site 0052
United States, Pennsylvania
Local Institution
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19111
Contact:Contact: Site 0059
Local Institution
[Not yet recruiting]
Pittsburgh, Pennsylvania, United States, 15240
Contact:Contact: Site 0040
United States, South Carolina
Local Institution
[Not yet recruiting]
Greenville, South Carolina, United States, 29607
Contact:Contact: Site 0058
United States, Tennessee
Local Institution
[Not yet recruiting]
Knoxville, Tennessee, United States, 37909
Contact:Contact: Site 0037
United States, Utah
Northern Utah Associates
[Recruiting]
Ogden, Utah, United States, 84403
Contact:Contact: Vincent Hansen, Site 0036
United States, Washington
Local Institution
[Not yet recruiting]
Seattle, Washington, United States, 98109
Contact:Contact: Site 0044
Canada, Ontario
Local Institution
[Not yet recruiting]
London, Ontario, Canada, N6A 4G5
Contact:Contact: Site 0049
Canada, Quebec
Local Institution
[Not yet recruiting]
Gatineau, Quebec, Canada, J8P 7H2
Contact:Contact: Site 0054
Local Institution
[Not yet recruiting]
Montreal, Quebec, Canada, H1T 2M4
Contact:Contact: Site 0048
France
Local Institution
[Recruiting]
Nantes Cedex 1, France, 44000
Contact:Contact: Site 0022
Local Institution
[Not yet recruiting]
Paris Cedex 12, France, 75571
Contact:Contact: Site 0021
Local Institution
[Not yet recruiting]
Pessac, France, 33604
Contact:Contact: Site 0020
Local Institution
[Recruiting]
Poitiers Cedex, France, 86021
Contact:Contact: Site 0019
Local Institution
[Recruiting]
Saint Pierre Cedex, France, 97448
Contact:Contact: Site 0043
Germany
Local Institution
[Not yet recruiting]
Dresden, Germany, 01307
Contact:Contact: Site 0013
Local Institution
[Not yet recruiting]
Freiburg, Germany, 79106
Contact:Contact: Site 0042
Local Institution
[Not yet recruiting]
Hamm, Germany, 59063
Contact:Contact: Site 0009
Local Institution
[Not yet recruiting]
Heidelberg, Germany, 69120
Contact:Contact: Site 0041
Local Institution
[Not yet recruiting]
Lubeck, Germany, 23538
Contact:Contact: Site 0056
Local Institution
[Not yet recruiting]
Mainz, Germany, 55101
Contact:Contact: Site 0011
Local Institution
[Not yet recruiting]
Tuebingen, Germany, 72076
Contact:Contact: Site 0008
Italy
Local Institution
[Not yet recruiting]
Ancona, Italy, 60126
Contact:Contact: Site 0003
Local Institution
[Not yet recruiting]
Bologna, Italy, 40138
Contact:Contact: Site 0002
Local Institution
[Not yet recruiting]
Firenze, Italy, 50134
Contact:Contact: Site 0005
Local Institution
[Not yet recruiting]
Roma, Italy, 00144
Contact:Contact: Site 0007
Local Institution
[Not yet recruiting]
Roma, Italy, 00161
Contact:Contact: Site 0004
Local Institution
[Not yet recruiting]
Torino, Italy, 10126
Contact:Contact: Site 0001
Japan, Aichi
Local Institution
[Recruiting]
Nagoya-shi, Aichi, Japan, 4678602
Contact:Contact: Site 0030
Japan, Kyoto
Local Institution
[Recruiting]
Kyoto-shi, Kyoto, Japan, 6028566
Contact:Contact: Site 0031
Japan, Niigata
Local Institution
[Recruiting]
Niigata-shi, Niigata, Japan, 9518566
Contact:Contact: Site 0029
Japan, Okayama
Local Institution
[Recruiting]
Okayama-shi, Okayama, Japan, 7011192
Contact:Contact: Site 0032
Japan, Tokyo
Local Institution
[Not yet recruiting]
Shibuya-ku, Tokyo, Japan, 1508935
Contact:Contact: Site 0027
Local Institution
[Recruiting]
Tachikawa-shi, Tokyo, Japan, 1900014
Contact:Contact: Site 0028
Netherlands
Local Institution
[Not yet recruiting]
Amsterdam, Netherlands, 1081 HV
Contact:Contact: Site 0017
Local Institution
[Not yet recruiting]
Groningen, Netherlands, 9713 GZ
Contact:Contact: Site 0016
Local Institution
[Not yet recruiting]
Maastrict, Netherlands, 6229 HX
Contact:Contact: Site 0018
Local Institution
[Not yet recruiting]
Utrecht, Netherlands, 3584 CX
Contact:Contact: Site 0015
Spain
Hospital De La Santa Creu I Sant Pau
[Recruiting]
Barcelona, Spain, 08025
Contact:Contact: Miquel Granell, Site 0025 +34935597453
Hospital Universitario 12 De Octubre
[Recruiting]
Madrid, Spain, 28041
Contact:Contact: Joaquin Martinez Lopez, Site 0024
Clinica Universitaria De Navarra
[Recruiting]
Pamplona, Spain, 31008
Contact:Contact: Jesus San Miguel, Site 0010 +34948255400
Hospital Universitario Dr. Peset
[Recruiting]
Valencia, Spain, 46017
Contact:Contact: Javier De La Rubia Comos, Site 0026 +34961622743
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: BMS clinical trial educational resource
Available IPD/Information:
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