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

Meletios A. Dimopoulos, Paul G. Richardson, Rudolf Schlag, Nuriet K. Khuageva, Ofer Shpilberg, Efstathios Kastritis, Martin Kropff, Maria T. Petrucci, Michel Delforge, Julia Alexeeva, Rik Schots, T. Masszi, Maria Victoria Mateos, William Deraedt, Kevin Liu, Andrew Cakana, Helgi Van De Velde, Jesús F. San Miguel

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Abstract

Purpose: 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. Patients and Methods: Patients received nine 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 were 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 were 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 (<75 years; P = .006) and less severe impairment (GFR ≥ 30 mL/min; P = .027) were associated with higher reversal rates. In addition, treatment with VMP approached significance (P = .07). 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. Conclusion: 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.

Original languageEnglish
Pages (from-to)6086-6093
Number of pages8
JournalJournal of Clinical Oncology
Volume27
Issue number36
DOIs
Publication statusPublished - Dec 20 2009

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Melphalan
Prednisone
Multiple Myeloma
Cohort Studies
Kidney
Glomerular Filtration Rate
Bortezomib
Survival
Creatinine
Multivariate Analysis

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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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. / Dimopoulos, Meletios A.; Richardson, Paul G.; Schlag, Rudolf; Khuageva, Nuriet K.; Shpilberg, Ofer; Kastritis, Efstathios; Kropff, Martin; Petrucci, Maria T.; Delforge, Michel; Alexeeva, Julia; Schots, Rik; Masszi, T.; Mateos, Maria Victoria; Deraedt, William; Liu, Kevin; Cakana, Andrew; Van De Velde, Helgi; San Miguel, Jesús F.

In: Journal of Clinical Oncology, Vol. 27, No. 36, 20.12.2009, p. 6086-6093.

Research output: Contribution to journalArticle

Dimopoulos, MA, Richardson, PG, Schlag, R, Khuageva, NK, Shpilberg, O, Kastritis, E, Kropff, M, Petrucci, MT, Delforge, M, Alexeeva, J, Schots, R, Masszi, T, Mateos, MV, Deraedt, W, Liu, K, Cakana, A, Van De Velde, H & San Miguel, JF 2009, '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, vol. 27, no. 36, pp. 6086-6093. https://doi.org/10.1200/JCO.2009.22.2232
Dimopoulos, Meletios A. ; Richardson, Paul G. ; Schlag, Rudolf ; Khuageva, Nuriet K. ; Shpilberg, Ofer ; Kastritis, Efstathios ; Kropff, Martin ; Petrucci, Maria T. ; Delforge, Michel ; Alexeeva, Julia ; Schots, Rik ; Masszi, T. ; Mateos, Maria Victoria ; Deraedt, William ; Liu, Kevin ; Cakana, Andrew ; Van De Velde, Helgi ; San Miguel, Jesús F. / 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. In: Journal of Clinical Oncology. 2009 ; Vol. 27, No. 36. pp. 6086-6093.
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abstract = "Purpose: 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. Patients and Methods: Patients received nine 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 were 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 were 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 (<75 years; P = .006) and less severe impairment (GFR ≥ 30 mL/min; P = .027) were associated with higher reversal rates. In addition, treatment with VMP approached significance (P = .07). 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. Conclusion: 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.",
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TY - JOUR

T1 - 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

T2 - Cohort analysis of the phase III VISTA study

AU - Dimopoulos, Meletios A.

AU - Richardson, Paul G.

AU - Schlag, Rudolf

AU - Khuageva, Nuriet K.

AU - Shpilberg, Ofer

AU - Kastritis, Efstathios

AU - Kropff, Martin

AU - Petrucci, Maria T.

AU - Delforge, Michel

AU - Alexeeva, Julia

AU - Schots, Rik

AU - Masszi, T.

AU - Mateos, Maria Victoria

AU - Deraedt, William

AU - Liu, Kevin

AU - Cakana, Andrew

AU - Van De Velde, Helgi

AU - San Miguel, Jesús F.

PY - 2009/12/20

Y1 - 2009/12/20

N2 - Purpose: 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. Patients and Methods: Patients received nine 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 were 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 were 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 (<75 years; P = .006) and less severe impairment (GFR ≥ 30 mL/min; P = .027) were associated with higher reversal rates. In addition, treatment with VMP approached significance (P = .07). 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. Conclusion: 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.

AB - Purpose: 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. Patients and Methods: Patients received nine 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 were 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 were 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 (<75 years; P = .006) and less severe impairment (GFR ≥ 30 mL/min; P = .027) were associated with higher reversal rates. In addition, treatment with VMP approached significance (P = .07). 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. Conclusion: 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.

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