title: Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results.
abstract: 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.
authors.affiliation: Hôpital Huriez, Lille, France;
authors.forename: Xavier
authors.initials: X
authors.lastname: Leleu
authors.affiliation: Hôpital Lyon Sud, Lyon Pierre Benite, France;
authors.forename: Lionel
authors.initials: L
authors.lastname: Karlin
authors.affiliation: Hôpital Côte de Nacre, Caen, France;
authors.forename: Margaret
authors.initials: M
authors.lastname: Macro
authors.affiliation: Hôpital de Brabois, Nancy Vandoeuvre, France;
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.affiliation: Hôpital Saint Antoine, Assistance Publiques des Hôpitaux de Paris, Paris, France;
authors.forename: Laurent
authors.initials: L
authors.lastname: Garderet
authors.affiliation: Hôpital Purpan, Toulouse, France;
authors.forename: Murielle
authors.initials: M
authors.lastname: Roussel
authors.affiliation: Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France;
authors.forename: Bertrand
authors.initials: B
authors.lastname: Arnulf
authors.affiliation: Hôpital A. Michallon, Grenoble, France;
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pegourie
authors.affiliation: Hôpital Robert Debré, Reims, France;
authors.forename: Brigitte
authors.initials: B
authors.lastname: Kolb
authors.affiliation: Institut Paoli Calmettes, Marseille, France;
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Stoppa
authors.affiliation: Hôpital Bobigny-Avicennes, Assistance Publiques-Hôpitaux de Paris, Paris, France;
authors.forename: Sabine
authors.initials: S
authors.lastname: Brechiniac
authors.affiliation: Hôpital du Haut-Lévèque, Bordeaux Pessac, France;
authors.forename: Gerald
authors.initials: G
authors.lastname: Marit
authors.affiliation: Hôpital Huriez, Lille, France;
authors.forename: Beatrice
authors.initials: B
authors.lastname: Thielemans
authors.affiliation: Hôpital Huriez, Lille, France;
authors.forename: Brigitte
authors.initials: B
authors.lastname: Onraed
authors.affiliation: Institut Curie, Paris, France;
authors.forename: Claire
authors.initials: C
authors.lastname: Mathiot
authors.affiliation: Hôpital de la côte basque, Bayonne, France;
authors.forename: Anne
authors.initials: A
authors.lastname: Banos
authors.affiliation: Hôpital Jean Bernard, Poitiers, France;
authors.forename: Laurence
authors.initials: L
authors.lastname: Lacotte
authors.affiliation: Hôpital Départemental, La Roche sur Yon, France;
authors.forename: Mourad
authors.initials: M
authors.lastname: Tiab
authors.affiliation: Hôpital du Bocage, Angers, France;
authors.forename: Mamoun
authors.initials: M
authors.lastname: Dib
authors.affiliation: Hôpital Archet, Nice, France;
authors.forename: Jean-Gabriel
authors.initials: JG
authors.lastname: Fuzibet
authors.affiliation: Hôpital Huriez, Lille, France;
authors.forename: Marie Odile
authors.initials: MO
authors.lastname: Petillon
authors.affiliation: Hopital de Perigueux, Perigueux, France;
authors.forename: Philippe
authors.initials: P
authors.lastname: Rodon
authors.affiliation: Hôpital Général, Dunkerque, France;
authors.forename: Marc
authors.initials: M
authors.lastname: Wetterwald
authors.affiliation: Hôpital Sud, Amiens, France;
authors.forename: Bruno
authors.initials: B
authors.lastname: Royer
authors.affiliation: Hôpital Archet, Nice, France;
authors.forename: Laurence
authors.initials: L
authors.lastname: Legros
authors.affiliation: Hôpital Bretonneau, Tours, France;
authors.forename: Lotfi
authors.initials: L
authors.lastname: Benboubker
authors.affiliation: Hôpital Sud, Rennes, France;
authors.forename: Olivier
authors.initials: O
authors.lastname: Decaux
authors.affiliation: Hôpital Pontchaillou, Rennes, France;
authors.forename: Martine
authors.initials: M
authors.lastname: Escoffre-Barbe
authors.affiliation: Hôpital d'Enfants, Dijon, France; and.
authors.forename: Denis
authors.initials: D
authors.lastname: Caillot
authors.affiliation: Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France;
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Fermand
authors.affiliation: Hotel Dieu, Nantes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.affiliation: Hôpital Purpan, Toulouse, France;
authors.forename: Michel
authors.initials: M
authors.lastname: Attal
authors.affiliation: Hôpital Purpan, Toulouse, France;
authors.forename: Herve
authors.initials: H
authors.lastname: Avet-Loiseau
authors.affiliation: Hôpital Huriez, Lille, France;
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002883:Chromosomes, Human, Pair 14 / Q000235:genetics*; D002886:Chromosomes, Human, Pair 17 / Q000235:genetics*; D002894:Chromosomes, Human, Pair 4 / Q000235:genetics*; D003907:Dexamethasone / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D017353:Gene Deletion; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D014178:Translocation, Genetic / Q000235:genetics*
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; C467566:pomalidomide