Lenalidomide in combination with melphalan and dexamethasone in patients with newly-diagnosed AL amyloidosis: a multicenter phase 1/2 dose escalation study. - Université Claude Bernard Lyon 1 Accéder directement au contenu
Article Dans Une Revue Blood Année : 2010

Lenalidomide in combination with melphalan and dexamethasone in patients with newly-diagnosed AL amyloidosis: a multicenter phase 1/2 dose escalation study.

Résumé

New treatment options are required for primary systemic AL amyloidosis (AL). This phase 1 / 2 dose-escalation study aimed to determine the maximum tolerated dose (MTD) of lenalidomide in combination with melphalan and dexamethasone (M-dex), and to assess the efficacy and tolerability of this therapy for patients with de novo AL. Twenty-six patients were enrolled across 4 cohorts: M-dex plus lenalidomide 5, 10, 15 and 20 mg once daily on days 1-21 in a 28-day cycle. No DLT was observed in cohort n degrees 1, 2 and 3. Four patients / 7 in cohort n degrees 4, M-dex + lenalidomide 20 mg/day, experienced dose-limiting toxicity. 15 mg lenalidomide was defined as MTD. A complete hematologic response was achieved in 42% at the dose of 15 mg of lenalidomide / day. After a median follow-up of 19 months, estimated 2-year overall survival and event-free survival (EFS) were 80.8% and 53.8%, respectively. Hematologic and organ responses were both associated with superior EFS rates (P = .0001). A higher EFS was also observed in patients whose free light chains decreased by more than 50% during therapy (P = .019). Lenalidomide 15 mg/day plus M-dex is a new effective combination therapy in patients with newly diagnosed AL. This study is registered at http://clinicaltrials.gov as NCT00621400.

Domaines

Immunologie

Dates et versions

hal-00512420 , version 1 (30-08-2010)

Identifiants

Citer

Philippe Moreau, Arnaud Jaccard, Lotfi Benboubker, Bruno Royer, Xavier Leleu, et al.. Lenalidomide in combination with melphalan and dexamethasone in patients with newly-diagnosed AL amyloidosis: a multicenter phase 1/2 dose escalation study.. Blood, 2010, 116 (23), epub ahead of print. ⟨10.1182/blood-2010-07-294405⟩. ⟨hal-00512420⟩
161 Consultations
0 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More