PMID- 31664647
OWN - NLM
STAT- MEDLINE
DCOM- 20200615
LR  - 20200615
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 111
IP  - 1
DP  - 2020 Jan
TI  - Final results of a phase I study of carfilzomib, lenalidomide, and dexamethasone 
      for heavily pretreated multiple myeloma.
PG  - 57-64
LID - 10.1007/s12185-019-02754-3 [doi]
AB  - We report the final results from a multicenter, open-label phase I study of 
      carfilzomib plus lenalidomide and dexamethasone in Japanese patients with heavily 
      pretreated relapsed and/or refractory multiple myeloma (RRMM). Twenty-six RRMM 
      patients were enrolled and received a median of 4.0 prior regimens; 12/26 
      patients (46.2%) completed the planned 18 administration cycles (mean number of 
      cycles: 14.5 +/- 4.9). The safety profile was consistent with that of previous 
      carfilzomib studies. All patients experienced adverse events (AEs), but no new 
      safety concerns were observed. The most common grade >/= 3 AEs (incidence: >/= 10%) 
      were lymphocyte count decreased (46.2%), platelet count decreased (42.3%), and 
      neutrophil count decreased (34.6%). The overall response rate was 88.5% (23/26; 
      90% confidence interval: 72.8-96.8). Complete response (CR) or better was 
      achieved by 30.8% of patients compared with 3.8% in the interim analysis. The 
      median time to CR or better response was 9.4 months. Median progression-free 
      survival and duration of response were 19.5 months and 20.3 months, respectively. 
      Median overall survival was not reached. Long-term administration of carfilzomib 
      produced deep response and long-term disease control. The combination of 
      carfilzomib plus lenalidomide and dexamethasone was well tolerated and showed 
      promising clinical efficacy for heavily pretreated RRMM patients. CLINICAL TRIAL 
      REGISTRATION: This clinical trial was registered in the database 
      clinicaltrials.jp (clinical trial registration number: Japic CTI 142677).
FAU - Sugiura, Isamu
AU  - Sugiura I
AUID- ORCID: 0000-0002-4430-7544
AD  - Division of Hematology and Oncology, Toyohashi Municipal Hospital, 50 Aza 
      Hachiken-nishi, Aotake-cho, Toyohashi, Aichi, 441-8570, Japan. 
      sugiura-isamu@toyohashi-mh.jp.
FAU - Suzuki, Kenshi
AU  - Suzuki K
AD  - Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
FAU - Ri, Masaki
AU  - Ri M
AD  - Department of Hematology and Oncology, Nagoya City University Graduate School of 
      Medical Science, Nagoya, Japan.
FAU - Chou, Takaaki
AU  - Chou T
AD  - Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
FAU - Takezako, Naoki
AU  - Takezako N
AD  - Department of Hematology, National Hospital Organization Disaster Medical Center, 
      Tachikawa, Japan.
FAU - Sunami, Kazutaka
AU  - Sunami K
AD  - Department of Hematology, National Hospital Organization Okayama Medical Center, 
      Okayama, Japan.
FAU - Ishida, Tadao
AU  - Ishida T
AD  - Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
AD  - Department of Gastroenterology, Rheumatology and Clinical Immunology, Sapporo 
      Medical University School of Medicine, Sapporo, Japan.
FAU - Izumi, Tohru
AU  - Izumi T
AD  - Department of Hematology, Tochigi Cancer Center, Utsunomiya, Japan.
FAU - Ozaki, Shuji
AU  - Ozaki S
AD  - Department of Hematology, Tokushima Prefectural Central Hospital, Tokushima, 
      Japan.
FAU - Shumiya, Yoshihisa
AU  - Shumiya Y
AD  - Department of Oncology Clinical Development Planning, Ono Pharmaceutical, Osaka, 
      Japan.
FAU - Iida, Shinsuke
AU  - Iida S
AD  - Department of Hematology and Oncology, Nagoya City University Graduate School of 
      Medical Science, Nagoya, Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
DEP - 20191029
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Oligopeptides)
RN  - 72X6E3J5AR (carfilzomib)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Dexamethasone/*administration & dosage/adverse effects
MH  - Female
MH  - Humans
MH  - Japan
MH  - Lenalidomide/*administration & dosage/adverse effects
MH  - Lymphocyte Count
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/metabolism/pathology/physiopathology
MH  - Neutrophils/drug effects/metabolism
MH  - Oligopeptides/*administration & dosage/adverse effects
MH  - Platelet Count
MH  - Progression-Free Survival
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Carfilzomib
OT  - Clinical trial
OT  - Dexamethasone
OT  - Lenalidomide
OT  - Multiple myeloma
EDAT- 2019/10/31 06:00
MHDA- 2020/06/17 06:00
CRDT- 2019/10/31 06:00
PHST- 2019/06/28 00:00 [received]
PHST- 2019/09/24 00:00 [accepted]
PHST- 2019/09/24 00:00 [revised]
PHST- 2019/10/31 06:00 [pubmed]
PHST- 2020/06/17 06:00 [medline]
PHST- 2019/10/31 06:00 [entrez]
AID - 10.1007/s12185-019-02754-3 [pii]
AID - 10.1007/s12185-019-02754-3 [doi]
PST - ppublish
SO  - Int J Hematol. 2020 Jan;111(1):57-64. doi: 10.1007/s12185-019-02754-3. Epub 2019 
      Oct 29.