Phase 2 study of carfilzomib, thalidomide and dexamethasone as induction/consolidation therapy for newly diagnosed multiple myeloma
Mené en Europe sur 91 patients atteints d'un myélome multiple et éligibles à une greffe autologue de cellules souches, cet essai multicentrique de phase II évalue l'efficacité, du point de vue du taux de réponse complète, d'une combinaison carfilzomib, thalidomide et dexaméthase en traitement d'induction/consolidation (durée médiane de suivi : 23 mois)
Résumé en anglais
This multicenter phase 2 study of the European Myeloma Network investigated the combination of carfilzomib, thalidomide, and dexamethasone (KTd) as induction/consolidation therapy for transplant-eligible patients with previously untreated multiple myeloma (N=91). During KTd induction therapy, patients received 4 cycles of carfilzomib 20/27 mg/m2 (n=50), 20/36 mg/m2 (n=20), 20/45 mg/m2 (n=21), or 20/56 mg/m2 (n=20) on days 1, 2, 8, 9, 15, and 16 of a 28-day cycle; thalidomide 200 mg on days 1–28; and dexamethasone 20 mg on days 1, 2, 8, 9, 15, and 16. After autologous stem cell transplantation, patients proceeded to KTd consolidation therapy, where the target doses of carfilzomib were 27 mg/m2, 36 mg/m2, 45 mg/m2, or 56 mg/m2 respectively, and thalidomide 50 mg. Common grade 3/4 adverse events included respiratory (15%), gastrointestinal (12%), and skin disorders (10%); polyneuropathy was infrequent (1%). Complete response rates after induction and consolidation treatment were 25% and 63%, respectively; rates of very good partial response or better after induction and consolidation were 68% and 89%, respectively. At a median follow-up of 23 months, the 36-month progression-free survival rate was 72%. The KTd induction and consolidation regimens were active, safe, and well-tolerated. This study was registered at http://www.trialregister.nl as NTR2422.
