PMID- 30531133
OWN - NLM
STAT- MEDLINE
DCOM- 20190507
LR  - 20190507
IS  - 0485-1439 (Print)
IS  - 0485-1439 (Linking)
VI  - 59
IP  - 11
DP  - 2018
TI  - [Safety and management of adverse events of ixazomib/lenalidomide/dexamethasone 
      therapy in Japanese patients with relapsed/refractory multiple myeloma].
PG  - 2399-2407
LID - 10.11406/rinketsu.59.2399 [doi]
AB  - Based on the outcomes of the TOURMALINE-MM1 trial-a global, randomized, 
      double-blind, placebo-controlled phase III clinical study-the use of an oral 
      proteasome inhibitor has been approved in combination with lenalidomide and 
      dexamethasone (Rd) for the treatment of relapsed/refractory multiple myeloma 
      (MM). In this study, we enrolled 41 Japanese patients, who constituted the safety 
      population. The overall incidence of adverse events (AEs) was similar in IRd and 
      placebo-Rd groups. AEs including thrombocytopenia, skin disorders (rash), 
      vomiting, nausea, and diarrhea occurred more frequently in the IRd group than in 
      the placebo-Rd group. There were no cumulative toxicities, and most toxicities 
      were usually manageable with close monitoring, supportive care, and dose 
      modifications. Compared with the overall safety population, the safety profile of 
      Japanese patients was consistent. Moreover, in Japanese patients, there were no 
      on-study deaths and the incidence of serious AEs was less frequent.
FAU - Iida, Shinsuke
AU  - Iida S
AD  - Department of Hematology and Oncology, Nagoya City University Graduate School of 
      Medical Sciences.
FAU - Izumi, Tohru
AU  - Izumi T
AD  - Department of Hematology, Tochigi Cancer Center.
FAU - Aotsuka, Nobuyuki
AU  - Aotsuka N
AD  - Department of Hematology and Oncology, Japanese Red Cross Narita Hospital.
FAU - Komeno, Takuya
AU  - Komeno T
AD  - Department of Hematology, National Hospital Organization Mito Medical Center.
FAU - Ishida, Tadao
AU  - Ishida T
AD  - Department of Hematology, Japanese Red Cross Medical Center.
FAU - Sunami, Kazutaka
AU  - Sunami K
AD  - Department of Hematology, National Hospital Organization Okayama Medical Center.
FAU - Handa, Hiroshi
AU  - Handa H
AD  - Department of Medicine and Clinical Science, Gunma University Graduate School of 
      Medicine.
FAU - Berg, Deborah
AU  - Berg D
AD  - Millennium Pharmaceuticals Inc., a Wholly Owned Subsidiary of Takeda 
      Pharmaceutical Company Limited.
FAU - Kase, Yoichi
AU  - Kase Y
AD  - Oncology Clinical Research Department, Oncology Therapeutic Area Unit for Japan 
      and Asia, Takeda Pharmaceutical Company Limited.
FAU - Soeda, Junpei
AU  - Soeda J
AD  - Japan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical 
      Company Limited.
LA  - jpn
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Japan
TA  - Rinsho Ketsueki
JT  - [Rinsho ketsueki] The Japanese journal of clinical hematology
JID - 2984782R
RN  - 0 (Boron Compounds)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 71050168A2 (ixazomib)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - F0P408N6V4 (Lenalidomide)
RN  - TE7660XO1C (Glycine)
SB  - IM
MH  - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/therapeutic use
MH  - Boron Compounds/administration & dosage/adverse effects
MH  - Dexamethasone
MH  - Double-Blind Method
MH  - Glycine/administration & dosage/adverse effects/analogs & derivatives
MH  - Humans
MH  - Lenalidomide/administration & dosage/adverse effects
MH  - *Multiple Myeloma/drug therapy
MH  - Thalidomide/administration & dosage/adverse effects
OTO - NOTNLM
OT  - AE management
OT  - Ixazomib
OT  - Multiple myeloma
OT  - TOURMALINE MM1study
EDAT- 2018/12/12 06:00
MHDA- 2019/05/08 06:00
CRDT- 2018/12/12 06:00
PHST- 2018/12/12 06:00 [entrez]
PHST- 2018/12/12 06:00 [pubmed]
PHST- 2019/05/08 06:00 [medline]
AID - 10.11406/rinketsu.59.2399 [doi]
PST - ppublish
SO  - Rinsho Ketsueki. 2018;59(11):2399-2407. doi: 10.11406/rinketsu.59.2399.