LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma

Summary

The study drug elotuzumab, has been clinically shown to be effective in treating relapsed/refractory MM in combination with either bortezomib, or lenalidomide and dexamethasone. Elotuzumab in combination with lenalidomide and dexamethasone is currently approved by the Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma. Carfilzomib is also FDA approved for treating multiple myeloma and frequently given in combination with lenalidomide and dexamethasone for treatment of relapsed/refractory MM. Based on these findings, this study will look at how subjects with relapsed/refractory MM respond to a combination treatment with the following drugs: elotuzumab, carfilzomib, lenalidomide and dexamethasone. The combination of these four drugs is not FDA approved and is experimental.

Timeline

Start

2018-01-09

Primary completion

2021-06-04

Completion

2025-02-14

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry As enrollment was halted early, this p-value is descriptive in nature and cannot determine the success/failure of the trial. NCT03361306 ↗

Publications

• Results Bhutani M, Foureau DM, Robinson M, Guo F, Fesenkova K, Atrash S, Paul B, Varga C, Friend R, Pineda-Roman M, Rigby K, Symanowski JT, Norek S, Tucker MR, Druhan LJ, Voorhees PM, Usmani SZ. A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. Clin Lymphoma Myeloma Leuk. 2023 Jul;23(7):535-544.e1. doi: 10.1016/j.clml.2023.03.016. Epub 2023 Apr 7.

Drugs

Indications