PMID- 24963043
OWN - NLM
STAT- MEDLINE
DCOM- 20150429
LR  - 20220410
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Print)
IS  - 0006-4971 (Linking)
VI  - 124
IP  - 6
DP  - 2014 Aug 7
TI  - A phase 2 single-center study of carfilzomib 56 mg/m2 with or without low-dose 
      dexamethasone in relapsed multiple myeloma.
PG  - 899-906
LID - 10.1182/blood-2014-02-556308 [doi]
AB  - Standard carfilzomib (20 mg/m(2) cycle 1, 27 mg/m(2) thereafter; 2- to 10-minute 
      infusion) is safe and effective in relapsed or refractory multiple myeloma 
      (R/RMM). We report phase 2 results of carfilzomib 20 mg/m(2) on days 1 to 2 of 
      cycle 1, 56 mg/m(2) thereafter (30-minute infusion), in R/RMM with the option of 
      adding dexamethasone (20 mg) for suboptimal response/progression. Forty-four 
      patients enrolled, all having prior bortezomib and immunomodulatory drugs and a 
      median of 5 prior regimens. Of 42 response-evaluable patients, 23 (55%) achieved 
      at least partial response (PR). Median (95% confidence interval) duration of 
      response, progression-free, and overall survival were 11.7 (6.7-14.7), 4.1 
      (2.5-11.8), and 20.3 months (6.4-not estimable), respectively. High-risk 
      cytogenetics did not impact outcomes. Treatment was active in 
      bortezomib-refractory subgroups, but these patients tended to have poorer 
      outcomes. Four/10 patients with prior allogeneic transplant achieved at least PR. 
      Of 6 patients who responded, progressed and had dexamethasone added, 4 achieved 
      at least stable disease. The most frequent grade 3/4 adverse events (AEs) 
      possibly related to carfilzomib included lymphopenia (43%), thrombocytopenia 
      (32%), hypertension (25%), pneumonia (18%), and heart failure (11%). Seven 
      patients (16%) discontinued treatment due to AEs. Carfilzomib 56 mg/m(2) +/- 
      dexamethasone was tolerable and provided durable responses. This trial was 
      registered at www.clinicaltrials.gov as #NCT01351623.
CI  - (c) 2014 by The American Society of Hematology.
FAU - Lendvai, Nikoletta
AU  - Lendvai N
AD  - Myeloma Service, Memorial Sloan-Kettering Cancer Center, New York, NY; Department 
      of Medicine, Weill Medical College of Cornell University, New York, NY; and.
FAU - Hilden, Patrick
AU  - Hilden P
AD  - Epidemiology and Biostatistics.
FAU - Devlin, Sean
AU  - Devlin S
AD  - Epidemiology and Biostatistics.
FAU - Landau, Heather
AU  - Landau H
AD  - Department of Medicine, Weill Medical College of Cornell University, New York, 
      NY; and Adult Bone Marrow Transplantation Service.
FAU - Hassoun, Hani
AU  - Hassoun H
AD  - Myeloma Service, Memorial Sloan-Kettering Cancer Center, New York, NY; Department 
      of Medicine, Weill Medical College of Cornell University, New York, NY; and.
FAU - Lesokhin, Alexander M
AU  - Lesokhin AM
AD  - Myeloma Service, Memorial Sloan-Kettering Cancer Center, New York, NY; Department 
      of Medicine, Weill Medical College of Cornell University, New York, NY; and.
FAU - Tsakos, Ioanna
AU  - Tsakos I
AD  - Department of Medicine, and.
FAU - Redling, Kaitlyn
AU  - Redling K
AD  - Department of Medicine, and.
FAU - Koehne, Guenther
AU  - Koehne G
AD  - Department of Medicine, Weill Medical College of Cornell University, New York, 
      NY; and Adult Bone Marrow Transplantation Service.
FAU - Chung, David J
AU  - Chung DJ
AD  - Department of Medicine, Weill Medical College of Cornell University, New York, 
      NY; and Adult Bone Marrow Transplantation Service.
FAU - Schaffer, Wendy L
AU  - Schaffer WL
AD  - Department of Medicine, Weill Medical College of Cornell University, New York, 
      NY; and Cardiology Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
FAU - Giralt, Sergio A
AU  - Giralt SA
AD  - Department of Medicine, Weill Medical College of Cornell University, New York, 
      NY; and Adult Bone Marrow Transplantation Service.
LA  - eng
SI  - ClinicalTrials.gov/NCT01351623
GR  - P30 CA008748/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20140624
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Boronic Acids)
RN  - 0 (Oligopeptides)
RN  - 0 (Pyrazines)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 69G8BD63PP (Bortezomib)
RN  - 72X6E3J5AR (carfilzomib)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - *Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Boronic Acids/therapeutic use
MH  - Bortezomib
MH  - Dexamethasone/*administration & dosage
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lenalidomide
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/genetics
MH  - Oligopeptides/*administration & dosage/adverse effects
MH  - Pyrazines/therapeutic use
MH  - Risk Factors
MH  - Thalidomide/analogs & derivatives/therapeutic use
MH  - Treatment Outcome
PMC - PMC4624439
EDAT- 2014/06/26 06:00
MHDA- 2015/04/30 06:00
PMCR- 2014/08/07
CRDT- 2014/06/26 06:00
PHST- 2014/06/26 06:00 [entrez]
PHST- 2014/06/26 06:00 [pubmed]
PHST- 2015/04/30 06:00 [medline]
PHST- 2014/08/07 00:00 [pmc-release]
AID - S0006-4971(20)39876-1 [pii]
AID - 2014/556308 [pii]
AID - 10.1182/blood-2014-02-556308 [doi]
PST - ppublish
SO  - Blood. 2014 Aug 7;124(6):899-906. doi: 10.1182/blood-2014-02-556308. Epub 2014 
      Jun 24.