The efficacy and safety of lenalidomide plus dexamethasone in relapsed and/or
refractory multiple myeloma patients with impaired renal function.
Author(s): Dimopoulos M, Alegre A, Stadtmauer EA, Goldschmidt H, Zonder JA, de Castro CM,
Masliak Z, Reece D, Olesnyckyj M, Yu Z, Weber DM.
Affiliation(s): Department of Clinical Therapeutics, University of Athens School of Medicine,
Alexandra Hospital, Athens, Greece. mdimop@med.uoa.gr
Publication date & source: 2010, Cancer. , 116(16):3807-14
BACKGROUND: In patients with multiple myeloma, renal impairment (RI) at the time
of diagnosis is associated with poor survival. To the authors' knowledge, the
current retrospective analysis presented is the first to assess the impact of
various degrees of renal dysfunction on safety and efficacy outcomes in a large
cohort of patients with relapsed and/or refractory multiple myeloma who received
treatment with lenalidomide plus dexamethasone.
METHODS: Three hundred fifty-three patients from 2 large phase 3 trials were
randomized to receive lenalidomide (25 mg) plus dexamethasone (40 mg). For the
purpose of this analysis, RI was defined according to the calculated creatinine
clearance (CLCr) level as follows: mild or no RI (CLCr>or=60 mL/minute), moderate
RI (CLCr from >or=30 mL/minute to <60 mL/minute), and severe RI (CLCr<30
mL/minute).
RESULTS: The RI subgroups did not differ significantly in terms of the overall
response rate (range, 50%-64%) or response quality (very good partial response or
better, 27%-37%). In all RI subgroups, the time to progression and
progression-free survival did not differ significantly compared with the mild or
no RI group. Patients with RI experienced an increased incidence of
thrombocytopenia, required more frequent lenalidomide dose reduction or
interruption, and had shorter overall survival than patients with mild or no RI
(P=.006). Lenalidomide plus dexamethasone led to improvement in renal function in
the majority of patients.
CONCLUSIONS: The results from this study indicated that, with careful monitoring
of the CLCr level and adverse events as well as appropriate dose adjustments,
lenalidomide plus dexamethasone is an effective and well tolerated treatment
option for patients with multiple myeloma who have RI.
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