Study of Carfilzomib Weekly Plus Melphalan and Prednisone in Untreated Symptomatic Elderly Multiple Myeloma

Summary

IFM 2012-03 protocol is a Phase 2 multicenter nonrandomized open in elderly patients with multiple myeloma at diagnosis. Study primary objectives are in the first step to determine Maximum tolerated dose (MTD) of Carfilzomib Weekly based on definition of Dose-limiting toxicities (DLTs) and in the second step to expanded cohort, to determine the VGPR (Very Good Partial Response) + CR (Complete Response) rate of Carfilzomib Weekly at the MTD in combination with Melphalan Prednisone at the end of the 9 induction cycles.

Timeline

Start

2014-01-08

Primary completion

2016-07-17

Completion

2021-07-31

Publications

• Results Leleu X, Fouquet G, Richez V, Guidez S, Duhamel A, Machuron F, Karlin L, Kolb B, Tiab M, Araujo C, Meuleman N, Malfuson JV, Bourquard P, Lenain P, Roussel M, Jaccard A, Petillon MO, Belhadj-Merzoug K, Lepeu G, Chretien ML, Fontan J, Rodon P, Schmitt A, Offner F, Voillat L, Cereja S, Kuhnowski F, Rigaudeau S, Decaux O, Humbrecht-Kraut C, Frayfer J, Fitoussi O, Roos-Weil D, Eisenmann JC, Dorvaux V, Voog EG, Attal M, Moreau P, Avet-Loiseau H, Hulin C, Facon T. Carfilzomib Weekly plus Melphalan and Prednisone in Newly Diagnosed Transplant-Ineligible Multiple Myeloma (IFM 2012-03): A Phase I Trial. Clin Cancer Res. 2019 Jul 15;25(14):4224-4230. doi: 10.1158/1078-0432.CCR-18-3642. Epub 2019 May 3.

Drugs

Indications