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VMP (bortezomib, melphalan, and prednisone) is active and well tolerated in newly diagnosed patients with multiple myeloma with moderately impaired renal function, and results in reversal of renal impairment: Cohort analysis of the phase III Vista study
Journal of Clinical Oncology, 10/29/09

Dimopoulos MA et al. – The goal of this study was to assess bortezomib plus melphalan and prednisone (VMP) and melphalan and prednisone (MP) in previously untreated patients with multiple myeloma (MM) with renal impairment enrolled on the phase III VISTA study, and to evaluate renal impairment reversibility. VMP is a feasible, active, and well-tolerated treatment option for previously untreated patients with MM with moderate renal impairment, resulting in 44% renal impairment reversal.

Methods

Patients received 9 6-week cycles of VMP (bortezomib 1.3 mg/m2, melphalan 9 mg/m2, prednisone 60 mg/m2) or MP
Patients with serum creatinine higher than 2 mg/dL excluded

Results

In the VMP/MP arms, 6%/4%, 27%/30%, and 67%/66% of patients had baseline glomerular filtration rate (GFR) of 30, 31 to 50, and higher than 50 mL/min, respectively
Response rates higher and time to progression (TTP) and overall survival (OS) longer with VMP versus MP across renal cohorts
Response rates with VMP and TTP in both arms did not appear significantly different between patients with GFR ⊾ 50 or higher than 50 mL/min; OS appeared somewhat longer in patients with normal renal function in both arms
Renal impairment reversal (baseline GFR < 50 improving to > 60 mL/min) was seen in 49 (44%) of 111 patients receiving VMP versus 40 (34%) of 116 patients receiving MP
By multivariate analysis, younger age and less severe impairment associated with higher reversal rates
In both arms, rates of grade 4 and 5 adverse events (AEs) and
Treatment with VMP approached significance
In both arms, rates of grade 4 and 5 adverse events (AEs) and serious AEs appeared higher in patients with renal impairment; with VMP, rates of discontinuations/bortezomib dose reductions due to AEs did not appear affected

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