Clinical trial · Interventional
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 Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3)
NCT02654132CI-TRIAL-00061867completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Elotuzumab | Drug | Elotuzumab | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Elotuzumab Arm
- 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
- interventionNames
- Drug: Elotuzumab
- Drug: Pomalidomide
- Drug: Dexamethasone
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDDimopoulos 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
- DERIVEDDimopoulos 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