NCT02654132 · CITED IN SOURCE DOCUMENTS

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)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2022-11-01

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

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
intervention Names
Drug: Elotuzumab
Drug: Pomalidomide
Drug: Dexamethasone
label
Elotuzumab Arm
type
EXPERIMENTAL
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 Names
Drug: Pomalidomide
Drug: Dexamethasone
label
Control Arm
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Elotuzumab Arm
name
Elotuzumab
type
DRUG
arm Group Labels
Control Arm
Elotuzumab Arm
name
Pomalidomide
other Names
Pomalyst
type
DRUG
arm Group Labels
Control Arm
Elotuzumab Arm
name
Dexamethasone
other Names
Decadron, Dexamethasone, Intensol, Dexpak, Taperpak
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 117
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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
measure
Progression Free Survival (PFS)
time Frame
From randomization to date of progression or death (up to approximately 21 months)

secondary Outcomes

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.
measure
Objective Response Rate (ORR)
time Frame
From first dose to disease progression (up to approximately 21 months)
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.
measure
Overall Survival (OS)
time Frame
From randomization to death (up to approximately 52 months)

Full 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.

Source references

references

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.
pmid
35960908
type
DERIVED
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.
pmid
30403938
type
DERIVED