Clinical trial · Interventional
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)
NCT01239797CI-TRIAL-00058815ELOQUENT - 2completedPhase 3Results 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 the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Dexamethasone (IV) | Drug | Dexamethasone | ALIAS |
| Dexamethasone (Oral) | Drug | Dexamethasone | ALIAS |
| Elotuzumab (BMS-901608; HuLuc63) | Biological | Elotuzumab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lenalidomide + Dexamethasone
- interventionNames
- Drug: Lenalidomide
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Lenalidomide + Dexamethasone +Elotuzumab
- interventionNames
- Drug: Lenalidomide
- Drug: Dexamethasone (Oral)
- Drug: Dexamethasone (IV)
- Biological: Elotuzumab (BMS-901608; HuLuc63)
Primary outcomes (2)
- measure
- Median Progression Free Survival (PFS)
- timeFrame
- From randomization up to 326 events (up to approximately 38 months)
- description
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: * Documented progression from most recent line of therapy * 1-3 prior lines of therapy * Measurable disease * Life expectancy ≥3 months * Prior treatment with Lenalidomide permitted if: 1. Best response achieved was ≥Partial Response (PR) 2. Patient was not refractory 3. Patient did not discontinue due to a Grade ≥3 related adverse event 4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression Exclusion Criteria: * Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma * Active plasma cell leukemia * Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C
References
Publications (3)
- DERIVEDDimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11. PMID 30204239
- DERIVEDPassey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9. PMID 28070715
- DERIVEDLonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2. PMID 26035255