Study of Bortezomib and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Phase 2 Completed 185 enrolled Bristol-Myers Squibb AbbVie · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens \[progression free survival (PFS)\].

Timeline

Start: 2011-11-30
Primary completion: 2014-05-30
Completion: 2017-04-21

Outcome

Missed primary endpoint

registry p = 0.0923; Hazard Ratio (HR) 0.72 (95% CI 0.49 to 1.06); Log Rank NCT01478048 ↗

Publications

Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Elotuzumab	Monoclonal antibody	10 mg/kg	Intravenous
Background	Bortezomib	Small molecule	1.3 mg/m2	Intravenous
Comparator	Dexamethasone	Small molecule	8 mg	Oral
Comparator	Dexamethasone	Small molecule	20 mg	Oral