PMID- 27434748
OWN - NLM
STAT- MEDLINE
DCOM- 20170515
LR  - 20171116
IS  - 1365-2141 (Electronic)
IS  - 0007-1048 (Linking)
VI  - 175
IP  - 3
DP  - 2016 Nov
TI  - Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 
      single-arm safety study in patients with relapsed/refractory multiple myeloma.
PG  - 448-456
LID - 10.1111/bjh.14263 [doi]
AB  - Elotuzumab is an immunostimulatory, humanized immunoglobulin G1 monoclonal 
      antibody that selectively targets and kills signalling lymphocytic activation 
      molecule family member 7-expressing myeloma cells. We evaluated the safety and 
      tolerability of elotuzumab 10 mg/kg combined with thalidomide 50-200 mg and 
      dexamethasone 40 mg (with/without cyclophosphamide 50 mg) in patients with 
      relapsed/refractory multiple myeloma (RRMM). The primary endpoint was the 
      proportion of grade >/=3 non-haematological adverse events (AEs); other endpoints 
      included the number of dose reductions/discontinuations and efficacy. Forty 
      patients were treated, who had a median of three previous therapies, including 
      bortezomib (98%) and lenalidomide (73%). Grade >/=3 non-haematological AEs were 
      reported in 63% of patients, most commonly asthenia (35%) and peripheral oedema 
      (25%). Six (15%) patients had an infusion reaction. Twenty-six (65%) patients had 
      >/=1 dose reduction/discontinuation due to an AE, none related to elotuzumab. 
      Overall response rate was 38%; median progression-free survival was 3.9 months. 
      Median overall survival was 16.3 months and the 1-year survival rate was 63%. 
      Minimal incremental toxicity was observed with addition of elotuzumab to 
      thalidomide/dexamethasone with or without cyclophosphamide, and efficacy data 
      suggest clinical benefit in a highly pre-treated population. Elotuzumab combined 
      with thalidomide may provide an additional treatment option for patients with 
      RRMM.
CI  - (c) 2016 John Wiley & Sons Ltd.
FAU - Mateos, Maria-Victoria
AU  - Mateos MV
AD  - Haematology Department, Complejo Asistencial Universitario de Salamanca/Instituto 
      Biosanitario de Salamanca (IBSAL), Salamanca, Spain. mvmateos@usal.es.
FAU - Granell, Miguel
AU  - Granell M
AD  - Haematology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
FAU - Oriol, Albert
AU  - Oriol A
AD  - Institut Catala d'Oncologia, Institut Josep Carreras, Hospital Germans Trias, 
      Pujol, Badalona, Spain.
FAU - Martinez-Lopez, Joaquin
AU  - Martinez-Lopez J
AD  - Haematology Department, Hospital Universitario 12 de Octubre, Medicine School 
      Complutense University, CNIO, Madrid, Spain.
FAU - Blade, Joan
AU  - Blade J
AD  - Haematology Department, Hospital Clinica, IDIBAPS, Barcelona, Spain.
FAU - Hernandez, Miguel T
AU  - Hernandez MT
AD  - Complejo Hospitalario Universitario de Canarias, Santa Cruz de Tenerife, Spain.
FAU - Martin, Jesus
AU  - Martin J
AD  - Haematology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
FAU - Gironella, Mercedes
AU  - Gironella M
AD  - Haematology Department, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
FAU - Lynch, Mark
AU  - Lynch M
AD  - Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Bleickardt, Eric
AU  - Bleickardt E
AD  - Oncology Clinical Development, Bristol-Myers Squibb, Princeton, NJ, USA.
FAU - Paliwal, Prashni
AU  - Paliwal P
AD  - Global Regulatory Safety and Biometrics, Bristol-Myers Squibb, Princeton, NJ, 
      USA.
FAU - Singhal, Anil
AU  - Singhal A
AD  - AbbVie Biotherapeutics Inc. (ABR), Redwood City, CA, USA.
FAU - San-Miguel, Jesus
AU  - San-Miguel J
AD  - Clinical and Translational Medicine, Clinica Universidad de Navarra - CIMA 
      (Centro de Investigacion Medica Aplicada) - IdiSNA (Instituto de Investigacion 
      Sanitaria de Navarra), Pamplona, Spain.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160719
PL  - England
TA  - Br J Haematol
JT  - British journal of haematology
JID - 0372544
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 1351PE5UGS (elotuzumab)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Dexamethasone/administration & dosage
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy/mortality/*pathology
MH  - Neoplasm Staging
MH  - Recurrence
MH  - Retreatment
MH  - Survival Analysis
MH  - Thalidomide/administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - elotuzumab
OT  - multiple myeloma
OT  - relapsed/refractory
OT  - signalling lymphocytic activation molecule family member 7
OT  - thalidomide
EDAT- 2016/10/28 06:00
MHDA- 2017/05/16 06:00
CRDT- 2016/07/20 06:00
PHST- 2016/03/22 00:00 [received]
PHST- 2016/06/07 00:00 [accepted]
PHST- 2016/10/28 06:00 [pubmed]
PHST- 2017/05/16 06:00 [medline]
PHST- 2016/07/20 06:00 [entrez]
AID - 10.1111/bjh.14263 [doi]
PST - ppublish
SO  - Br J Haematol. 2016 Nov;175(3):448-456. doi: 10.1111/bjh.14263. Epub 2016 Jul 19.