PMID- 25749662
OWN - NLM
STAT- MEDLINE
DCOM- 20160212
LR  - 20220801
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 101
IP  - 6
DP  - 2015 Jun
TI  - Phase I study of pegylated liposomal doxorubicin in combination with bortezomib 
      for Japanese patients with relapsed or refractory multiple myeloma.
PG  - 578-84
LID - 10.1007/s12185-015-1773-5 [doi]
AB  - This phase I open-label study evaluated the tolerability of pegylated liposomal 
      doxorubicin (PLD) and bortezomib combination in Japanese patients with relapsed 
      or refractory multiple myeloma. Eligible patients (>/=20 years) who had >/=1 line of 
      prior chemotherapy received bortezomib 1.3 mg/m(2) rapid intravenous infusion on 
      days 1, 4, 8 and 11 (each 21-day cycle), followed by PLD 30 mg/m(2) intravenous 
      infusion on day 4 (each cycle), up to 6 cycles. Dose-limiting toxicity (DLT), 
      defined as Grade 4 hematologic or Grade >/=3 non-hematologic, was evaluated through 
      end of day 21. All three patients enrolled in the study developed DLTs [Grade 4 
      thrombocytopenia (n = 2) and Grade 3 ileus (n = 1)]. The study was, therefore, 
      terminated without adding new patients, as per protocol-specified criteria. The 
      most common Grade 3-4 adverse events (AEs) were hematologic, including 
      thrombocytopenia, leucopenia, and neutropenia. The treatment was prematurely 
      discontinued in all three patients due to AEs: Grade 3 bronchiolitis (serious 
      AE), Grade 3 peripheral sensory neuropathy, and Grade 2 stomatitis. All patients 
      achieved partial response (efficacy, secondary endpoint). In conclusion, the 
      tolerability of PLD and bortezomib combination at dose levels approved in various 
      countries was not confirmed in relapsed or refractory multiple myeloma patients 
      from Japan.
FAU - Kusumoto, Shigeru
AU  - Kusumoto S
AD  - Department of Hematology and Oncology, Nagoya City University Graduate School of 
      Medical Sciences, Nagoya, Japan.
FAU - Sunami, Kazutaka
AU  - Sunami K
FAU - Inagaki, Mitsuo
AU  - Inagaki M
FAU - Iida, Shinsuke
AU  - Iida S
LA  - eng
SI  - ClinicalTrials.gov/NCT01371227
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150307
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (Antineoplastic Agents)
RN  - 0 (liposomal doxorubicin)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 69G8BD63PP (Bortezomib)
RN  - 80168379AG (Doxorubicin)
RN  - Thrombocytopenia 4
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Bortezomib/administration & dosage/adverse effects/*therapeutic use
MH  - Doxorubicin/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Female
MH  - Humans
MH  - Ileus/chemically induced
MH  - Japan/epidemiology
MH  - Male
MH  - Multiple Myeloma/*drug therapy/epidemiology
MH  - Neoplasm Recurrence, Local/*drug therapy/epidemiology
MH  - Neutropenia/chemically induced
MH  - Polyethylene Glycols/administration & dosage/adverse effects/therapeutic use
MH  - Thrombocytopenia/chemically induced
EDAT- 2015/03/10 06:00
MHDA- 2016/02/13 06:00
CRDT- 2015/03/10 06:00
PHST- 2014/12/12 00:00 [received]
PHST- 2015/02/25 00:00 [accepted]
PHST- 2015/02/25 00:00 [revised]
PHST- 2015/03/10 06:00 [entrez]
PHST- 2015/03/10 06:00 [pubmed]
PHST- 2016/02/13 06:00 [medline]
AID - 10.1007/s12185-015-1773-5 [doi]
PST - ppublish
SO  - Int J Hematol. 2015 Jun;101(6):578-84. doi: 10.1007/s12185-015-1773-5. Epub 2015 
      Mar 7.