Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Phase 3 Completed 748 enrolled Bristol-Myers Squibb AbbVie · collab

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: 2011-08-04
Primary completion: 2019-10-01
Completion: 2021-09-03

Publications

Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elotuzumab	Monoclonal antibody	10 mg/kg	Intravenous
Subject	Elotuzumab	Monoclonal antibody	20 mg/kg	Intravenous
Background	Dexamethasone	Small molecule	8 mg	Oral
Background	Dexamethasone	Small molecule	28 mg	Oral
Background	Dexamethasone	Small molecule	40 mg	Oral
Background	Lenalidomide	Other / unclassified	25 mg	Oral

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications