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Trial record 1 of 1 for:    NCT02654132
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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)

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ClinicalTrials.gov Identifier: NCT02654132
Recruitment Status : Active, not recruiting
First Posted : January 13, 2016
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborators:
Celgene
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
Actual Study Start Date : March 16, 2016
Actual Primary Completion Date : January 17, 2018
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
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: Elotuzumab
Drug: Pomalidomide
Other Name: Pomalyst

Drug: Dexamethasone
Other Name: 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 Name: Pomalyst

Drug: Dexamethasone
Other Name: Decadron, Dexamethasone, Intensol, Dexpak, Taperpak




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. 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 :
  1. Objective Response Rate (ORR) [ Time Frame: Approximately 14 months ]
    ORR is the proportion of randomized subjects who achieve a best response 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.

  2. Overall Survival (OS) [ Time Frame: Approximately 32 months ]
    OS is the time from randomization to the date of death from any cause. The survival time for subjects 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. NOTE: This data is immature and will be analyzed again at time of LPLV final.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654132


  Show 55 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Celgene
AbbVie
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] November 11, 2015
Statistical Analysis Plan  [PDF] May 1, 2018


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02654132     History of Changes
Other Study ID Numbers: CA204-125
2014-003282-19 ( EudraCT Number )
First Posted: January 13, 2016    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: May 2019

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

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Dexamethasone acetate
Pomalidomide
Thalidomide
Elotuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal