Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
Data from two randomized pivotal, phase 3 trials evaluating the combination of lenalidomide and dexamethasone in relapsed/refractory multiple myeloma (RRMM) were pooled to characterize the subset of patients who achieved long-term benefit of therapy (progression-free survival ⩾ 3 years). Patients with long-term benefit of therapy (n = 45) had a median duration of treatment of 48.1 months and a response rate of 100%. Humoral improvement (uninvolved immunoglobulin A) was more common in patients with long-term benefit of therapy (79% vs 55%; P = 0.002). Significant predictors of long-term benefit of therapy in multivariate analysis were age < 65 years (P = 0.03), β2-microglobulin <2.5 mg/l (P = 0.002) and fewer prior therapies (P = 0.002). The exposure-adjusted incidence rate (EAIR) of grade 3-4 neutropenia was lower in patients with long-term benefit of therapy (13.9 vs 38.2 per 100 patient-years). The EAIR for invasive second primary malignancy was the same in patients with long-term benefit of therapy and other patients (1.7 per 100 patient-years). These findings indicate that patients with RRMM can experience long-term benefit with lenalidomide and dexamethasone treatment with manageable side effects.
Department of Clinical Therapeutics, University of Athens School of Medicine, Athens, Greece.
M A
MA
Dimopoulos
Department of Biostatistics, Celgene Corporation, Summit, NJ, USA.
A S
AS
Swern
Department of Biostatistics, Celgene Corporation, Summit, NJ, USA.
J S
JS
Li
Department of Medical Affairs, Celgene Corporation, Summit, NJ, USA.
M
M
Hussein
Department of Drug Safety, Celgene Corporation, Summit, NJ, USA.
L
L
Weiss
Department of Medical Affairs, Celgene Corporation, Summit, NJ, USA.
Y
Y
Nagarwala
Department of Hematologic Malignancies, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
R
R
Baz
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide