PMID- 19858394
OWN - NLM
STAT- MEDLINE
DCOM- 20100121
LR  - 20151119
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 27
IP  - 36
DP  - 2009 Dec 20
TI  - 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.
PG  - 6086-93
LID - 10.1200/JCO.2009.22.2232 [doi]
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/m(2), melphalan 9 mg/m(2), prednisone 60 
      mg/m(2)) 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 < or = 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 < or = 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 > or = 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.
FAU - Dimopoulos, Meletios A
AU  - Dimopoulos MA
AD  - Department of Clinical Therapeutics, Alexandra Hospital, University of Athens, 
      School of Medicine, Athens, Greece. mdimop@med.uoa.gr
FAU - Richardson, Paul G
AU  - Richardson PG
FAU - Schlag, Rudolf
AU  - Schlag R
FAU - Khuageva, Nuriet K
AU  - Khuageva NK
FAU - Shpilberg, Ofer
AU  - Shpilberg O
FAU - Kastritis, Efstathios
AU  - Kastritis E
FAU - Kropff, Martin
AU  - Kropff M
FAU - Petrucci, Maria T
AU  - Petrucci MT
FAU - Delforge, Michel
AU  - Delforge M
FAU - Alexeeva, Julia
AU  - Alexeeva J
FAU - Schots, Rik
AU  - Schots R
FAU - Masszi, Tamas
AU  - Masszi T
FAU - Mateos, Maria-Victoria
AU  - Mateos MV
FAU - Deraedt, William
AU  - Deraedt W
FAU - Liu, Kevin
AU  - Liu K
FAU - Cakana, Andrew
AU  - Cakana A
FAU - van de Velde, Helgi
AU  - van de Velde H
FAU - San Miguel, Jesus F
AU  - San Miguel JF
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20091026
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Boronic Acids)
RN  - 0 (Pyrazines)
RN  - 69G8BD63PP (Bortezomib)
RN  - Q41OR9510P (Melphalan)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Boronic Acids/administration & dosage/adverse effects
MH  - Bortezomib
MH  - Cohort Studies
MH  - Disease Progression
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Kidney Diseases/*drug therapy/*etiology
MH  - Male
MH  - Melphalan/administration & dosage/adverse effects
MH  - Multiple Myeloma/*complications/*drug therapy
MH  - Multivariate Analysis
MH  - Prednisone/administration & dosage/adverse effects
MH  - Prognosis
MH  - Pyrazines/administration & dosage/adverse effects
MH  - Treatment Outcome
EDAT- 2009/10/28 06:00
MHDA- 2010/01/22 06:00
CRDT- 2009/10/28 06:00
PHST- 2009/10/28 06:00 [entrez]
PHST- 2009/10/28 06:00 [pubmed]
PHST- 2010/01/22 06:00 [medline]
AID - JCO.2009.22.2232 [pii]
AID - 10.1200/JCO.2009.22.2232 [doi]
PST - ppublish
SO  - J Clin Oncol. 2009 Dec 20;27(36):6086-93. doi: 10.1200/JCO.2009.22.2232. Epub 
      2009 Oct 26.