Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results

The combination of pomalidomide and low-dose dexamethasone (Pom-Dex) can be safely administered to patients with end-stage relapsed/refractory multiple myeloma (RRMM). However, we observed a shorter median progression-free survival (PFS) and overall survival (OS) in these patients when characterized...

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Veröffentlicht in:Blood 2015-02, Vol.125 (9), p.1411-1417
Hauptverfasser: Leleu, Xavier, Karlin, Lionel, Macro, Margaret, Hulin, Cyrille, Garderet, Laurent, Roussel, Murielle, Arnulf, Bertrand, Pegourie, Brigitte, Kolb, Brigitte, Stoppa, Anne Marie, Brechiniac, Sabine, Marit, Gerald, Thielemans, Beatrice, Onraed, Brigitte, Mathiot, Claire, Banos, Anne, Lacotte, Laurence, Tiab, Mourad, Dib, Mamoun, Fuzibet, Jean-Gabriel, Petillon, Marie Odile, Rodon, Philippe, Wetterwald, Marc, Royer, Bruno, Legros, Laurence, Benboubker, Lotfi, Decaux, Olivier, Escoffre-Barbe, Martine, Caillot, Denis, Fermand, Jean Paul, Moreau, Philippe, Attal, Michel, Avet-Loiseau, Herve, Facon, Thierry
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Sprache:eng
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Zusammenfassung:The combination of pomalidomide and low-dose dexamethasone (Pom-Dex) can be safely administered to patients with end-stage relapsed/refractory multiple myeloma (RRMM). However, we observed a shorter median progression-free survival (PFS) and overall survival (OS) in these patients when characterized with adverse cytogenetics (deletion 17p and translocation [4;14]) in the Intergroupe Francophone Myélome (IFM) 2009-02 trial. We then sought to determine whether MM with adverse cytogenetics would benefit more from Pom-Dex if exposed earlier in the multicenter IFM 2010-02 trial. The intention-to-treat population included 50 patients, with a median age of 63 years (38% were ≥65 years). Interestingly, there was a striking difference in time to progression (TTP), duration of response, and overall response rate (ORR) according to the presence of del(17p) compared with t(4;14) (TTP, 7.3 vs 2.8 months; duration of response, 8.3 vs 2.4 months; and ORR, 32% vs 15%). OS was prolonged after Pom-Dex, particularly in t(4;14), given the short TTP, suggesting that patients were rescued at relapse with further lines of therapy. Pom-Dex, a doublet immunomodulatory drug–based regimen, is active and well tolerated in adverse cytogenetic patients with early RRMM, particularly in those with del(17p), who are characterized by a high and rapid development of a refractoriness state and known for their poor prognosis. Future studies will determine the underlying mechanisms of Pom-Dex activity in del(17p). This trial is registered at www.clinicaltrials.gov as #NCT01745640. •Pom-Dex is active and well tolerated in adverse cytogenetic patients with early RRMM, particularly in those with del(17p).•Pom-Dex prolonged OS in adverse cytogenetic patients with early RRMM.
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2014-11-612069