Combination of bendamustine, lenalidomide, and dexamethasone (BLD) in patients with relapsed or refractory multiple myeloma is feasible and highly effective: results of phase I/II open-label, dose escalation study
Mené sur 29 patients atteints d'un myélome multiple récidivant ou réfractaire (âge médian : 63 ans), cet essai multicentrique de phase I/II évalue un traitement combinant bendamustine, lénalidomide et dexaméthasone (durée médiane de suivi : 13 mois)
This multicenter phase I/II trial investigated the combination of bendamustine (BEN), lenalidomide (LEN) and dexamethasone (DEX) (BLD) in repeating 4-week cycles as treatment for relapsed multiple myeloma (MM). Patients ≥18 years with symptomatic relapsed or refractory MM were enrolled. Phase I established maximum tolerated dose (MTD). Phase II assessed overall response rate (ORR) at the MTD. Secondary endpoints included progression free survival (PFS) and overall survival (OS). 29 evaluable patients were enrolled. Median age was 63 years (Range: 38-80). Median number of prior therapies was 3 (range: 1-6). MTD was BEN 75 mg/m2 (days 1 and 2), LEN 10 mg (days 1-21), and DEX 40 mg (weekly) of a 28 day cycle. Partial response (PR) rate was 52%, with very good partial response achieved in 24%, and minimal response in an additional 24% of patients. Median follow-up was 13 months, median OS has not been reached. One year OS is 93% (95% CI; 59-99%). Median PFS is 6.1 months (95% CI; 3.7-9.4 months) with one-year PFS of 20% (95% CI; 6-41%). Grade 3/4 adverse events included neutropenia, thrombocytopenia, anemia, hyperglycemia, and fatigue. This first phase I/II trial testing BLD as treatment of relapsed MM was feasible and highly active. This study is registered at www.clinicaltrials.gov as NCT01042704.