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)

• ClinicalTrials.gov Identifier: NCT02654132
• Recruitment Status: Completed
• First Posted: January 13, 2016
• Results First Posted: June 3, 2019
• Last Update Posted: November 1, 2022
• Sponsor: Bristol-Myers Squibb
• Collaborators: Celgene; AbbVie
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: December 31, 2015
• First Posted Date: January 13, 2016
• Results First Submitted Date: January 17, 2019
• Results First Posted Date: June 3, 2019
• Last Update Posted Date: November 1, 2022
• Actual Study Start Date: March 18, 2016
• Actual Primary Completion Date: January 17, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 5, 2022)

Progression Free Survival (PFS) [ Time Frame: From randomization to date of progression or death (up to approximately 21 months) ]

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

Original Primary Outcome Measures (submitted: January 12, 2016)

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

Current Secondary Outcome Measures (submitted: October 5, 2022)

• Objective Response Rate (ORR) [ Time Frame: From first dose to disease progression (up to approximately 21 months) ]
  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) [ Time Frame: From randomization to death (up to approximately 52 months) ]
  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.

Original Secondary Outcome Measures (submitted: January 12, 2016)

• Objective Response Rate (ORR) [ Time Frame: Approximately 14 months ]
• Overall Survival (OS) [ Time Frame: Approximately 32 months ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• Drug: Elotuzumab
• Drug: Pomalidomide
  Other Name: Pomalyst
• Drug: Dexamethasone
  Other Name: Decadron, Dexamethasone, Intensol, Dexpak, Taperpak

Study Arms

• 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

  Interventions:

  • Drug: Elotuzumab
  • Drug: Pomalidomide
  • Drug: Dexamethasone
• 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
  Interventions:

  • Drug: Pomalidomide
  • Drug: Dexamethasone

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 5, 2022): 117
• Original Estimated Enrollment (submitted: January 12, 2016): 114
• Actual Study Completion Date: October 21, 2021
• Actual Primary Completion Date: January 17, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Canada, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Spain, United States

Administrative Information

• NCT Number: NCT02654132
• Other Study ID Numbers: CA204-125; 2014-003282-19 ( EudraCT Number )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current

Collaborators

• Celgene
• AbbVie

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: October 2022