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History of Changes for Study: NCT02654132
Trial of Elotuzumab With or Without Pomalidomide and Low-dose Dexamethasone 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:  January 12, 2016 (v1)
Open or close this module Study Identification
Unique Protocol ID: CA204-125
Brief Title: Trial of Elotuzumab With or Without Pomalidomide and Low-dose Dexamethasone 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: January 2016
Overall Status: Not yet recruiting
Study Start: February 2016
Primary Completion: June 2017 [Anticipated]
Study Completion: December 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:		 January 12, 2016
Last Update Posted: January 13, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Bristol-Myers Squibb
Responsible Party: Sponsor
Collaborators: Celgene Corporation
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: 114 [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:
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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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services