Maintenance with weekly carfilzomib in elderly newly diagnosed multiple myeloma (IFM 2012-03).

person Arthur Bobin Poitiers Hospital, Poitiers, France info_outline Arthur Bobin, Guillemette Fouquet, Alain Duhamel, Salomon Manier, Lionel Karlin, Brigitte Kolb, Mourad Tiab, Carla Araujo, Nathalie Meuleman, Jean-Valère Malfuson, Pascal Bourquard, Pascal Lenain, Arnaud Jaccard, Michel Attal, Philippe Moreau, Herve Avet-Loiseau, Cyrille Hulin, Thierry Facon, Xavier Leleu, Karim Belhadj

Authors person Arthur Bobin Poitiers Hospital, Poitiers, France info_outline Arthur Bobin, Guillemette Fouquet, Alain Duhamel, Salomon Manier, Lionel Karlin, Brigitte Kolb, Mourad Tiab, Carla Araujo, Nathalie Meuleman, Jean-Valère Malfuson, Pascal Bourquard, Pascal Lenain, Arnaud Jaccard, Michel Attal, Philippe Moreau, Herve Avet-Loiseau, Cyrille Hulin, Thierry Facon, Xavier Leleu, Karim Belhadj Organizations Poitiers Hospital, Poitiers, France, Hematology, CHRU Lille, Lille, France, Department of Biostatistics, University Lille Nord de France, CHRU de Lille, Lille, France, Centre Hospitalier de Lille, Lille, France, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France, Hôpital Robert Debré, Reims Cedex, France, CHD Vendée, La Roche Sur Yon Cedex 9, France, Centre Hospitalier de la Côte Basque, Bayonne, France, Institut Jules Bordet, Bruxelles, Belgium, Hôpital d’Instruction des Armées Percy, Clamart, France, CHU Nîmes, Department of Haematology, Nîmes, France, Hématologie, Centre Henri Becquerel, Rouen, France, Centre Hospitalier Universitaire de Limoges-Hôpital Dupuytren, Limoges, France, Hôpital Purpan, Toulouse, France, CHU de Nantes-Hôtel Dieu, Nantes, France, University Hospital, Nantes, France, Department of Hematology, Hospital Haut Leveque, University Hospital Bordeaux, Pessac, France, Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France, CHU de Poitiers, Poitiers, France, Hematology, Hopital Henri Mondor, Créteil, France Abstract Disclosures Research Funding Other Foundation Background: Prolonged treatments have significantly improved survival in newly diagnosed multiple myeloma (NDMM). Lenalidomide (IMiDs), is currently approved in this indication, but remains a daily treatment, although oral, and may favor side effects in the long run. Furthermore, the use of a proteasome inhibitor (PI) is warranted in certain type of MM, such as high-risk. Carfilzomib, a second generation PI, has proved active combined with an acceptable security profile but its added benefit when given continuously is unknown. We thought to study maintenance Carfilzomib for elderly NDMM (eNDMM). Methods: The IFM 2012-03 multicenter phase I KMP (Carfilzomib, Melphalan, Prednisone) weekly study for eNDMM (≥ 65 years old) determined the maximal tolerated dose of weekly Carfilzomib at 70mg/m². We focus herein on the second part of the study with IV Carfilzomib monotherapy given at 36mg/m² for 13 cycles maintenance on an every 2 weeks schedule. Results: Thirty eNDMM were recruited in IFM 2012-03. Median age is 75, with 56% R-ISS 2 or 3 and 11% high-risk cytogenetic. With K weekly from 36 to 70mg/m², OS is reported at 93.3%, including 46.7% ≥CR; median PFS is 35.8 months and median OS was not reached. Twenty-two (73%) patients started K maintenance and 16 (73%) completed it. Four patients progressed and 2 stopped for AEs (renal amylosis, sensory neuropahty) during the maintenance phase. At maintenance completion, 50% were ≥CR. From the start of maintenance, in landmark analysis, median PFS is 28.1 months and the estimated 36-months OS approximately 70%. Conclusions: Carfilzomib monotherapy can be used safely in maintenance for 1 year in eNDMM, including for patients above 75 years. K maintenance may lead to deep response rate, certainly a most relevant prognostic factor for prolonged survival. Therefore, Carfilzomib maintenance, characterized with a simple administration modality, might be considered as an alternative to Lenalidomide and integrate the armamentarium of prolonged therapy in eNDMM. Clinical trial information: NCT02302495