drugset / Trial / NCT01239797
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma
RandomizedParallel-groupOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2011-06-20
- Primary completion
- 2014-09-02
- Completion
- 2021-04-21
Outcome
Met primary endpoint
registry analysis (superiority test); Lenalidomide + Dexamethasone + Elotuzumab vs Lenalidomide + Dexamethasone; p = 0.0014; Hazard Ratio (HR) 0.73 (95% CI 0.60 to 0.89); Log Rank NCT01239797 ↗
registry analysis (superiority test); Lenalidomide + Dexamethasone + Elotuzumab vs Lenalidomide + Dexamethasone; p = 0.0002; Odds Ratio (OR) 1.95 (95% CI 1.36 to 2.78); Cochran-Mantel-Haenszel NCT01239797 ↗
Publications
- Dimopoulos 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.
- Passey 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.
- Lonial 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 8 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 28 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Elotuzumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |