Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

M. Attal, PG. Richardson, SV. Rajkumar, J. San-Miguel, M. Beksac, I. Spicka, X. Leleu, F. Schjesvold, P. Moreau, MA. Dimopoulos, JS. Huang, J. Minarik, M. Cavo, HM. Prince, S. Macé, KP. Corzo, F. Campana, S. Le-Guennec, F. Dubin, KC. Anderson,...

. 2019 ; 394 (10214) : 2096-2107. [pub] 20191114

Jazyk angličtina Země Velká Británie

Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem, audiovizuální média

Perzistentní odkaz   https://www.medvik.cz/link/bmc20005688
E-zdroje Online Plný text

NLK ProQuest Central od 1992-01-04 do Před 3 měsíci
Nursing & Allied Health Database (ProQuest) od 1992-01-04 do Před 3 měsíci
Health & Medicine (ProQuest) od 1992-01-04 do Před 3 měsíci
Family Health Database (ProQuest) od 1992-01-04 do Před 3 měsíci
Psychology Database (ProQuest) od 1992-01-04 do Před 3 měsíci
Health Management Database (ProQuest) od 1992-01-04 do Před 3 měsíci
Public Health Database (ProQuest) od 1992-01-04 do Před 3 měsíci

Odkazy

PubMed 31735560
DOI 10.1016/s0140-6736(19)32556-5
Knihovny.cz E-zdroje

BACKGROUND: Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. METHODS: We did a randomised, multicentre, open-label, phase 3 study at 102 hospitals in 24 countries in Europe, North America, and the Asia-Pacific regions. Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor. Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody. We randomly assigned patients (1:1) to either isatuximab 10 mg/kg plus pomalidomide 4 mg plus dexamethasone 40 mg (20 mg for patients aged ≥75 years), or pomalidomide 4 mg plus dexamethasone 40 mg. Randomisation was done using interactive response technology and stratified according to the number of previous lines of treatment (2-3 vs >3) and age (<75 years vs ≥75 years). Treatments were assigned based on a permuted blocked randomisation scheme with a block size of four. The isatuximab-pomalidomide-dexamethasone group received isatuximab intravenously on days 1, 8, 15, and 22 in the first 28-day cycle, then on days 1 and 15 in subsequent cycles. Both groups received oral pomalidomide on days 1 to 21 in each cycle, and oral or intravenous dexamethasone on days 1, 8, 15, and 22 of each cycle. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal. Dose reductions for adverse reactions were permitted for pomalidomide and dexamethasone, but not for isatuximab. The primary endpoint was progression-free survival, determined by an independent response committee and assessed in the intention-to-treat population. Safety was assessed in all participants who received at least one dose of study drug. This study is registered at ClinicalTrials.gov, number NCT02990338. FINDINGS: Between Jan 10, 2017, and Feb 2, 2018, we randomly assigned 307 patients to treatment: 154 to isatuximab-pomalidomide-dexamethasone, and 153 to pomalidomide-dexamethasone. At a median follow-up of 11·6 months (IQR 10·1-13·9), median progression-free survival was 11·5 months (95% CI 8·9-13·9) in the isatuximab-pomalidomide-dexamethasone group versus 6·5 months (4·5-8·3) in the pomalidomide-dexamethasone group; hazard ratio 0·596, 95% CI 0·44-0·81; p=0·001 by stratified log-rank test. The most frequent treatment-emergent adverse events (any grade; isatuximab-pomalidomide-dexamethasone vs pomalidomide-dexamethasone) were infusion reactions (56 [38%] vs 0), upper respiratory tract infections (43 [28%] vs 26 [17%]), and diarrhoea (39 [26%] vs 29 [20%]). Adverse events with a fatal outcome were reported in 12 patients (8%) in the isatuximab-pomalidomide-dexamethasone group and 14 (9%) in the pomalidomide-dexamethasone group. Deaths due to treatment-related adverse events were reported for one patient (<1%) in the isatuximab-pomalidomide-dexamethasone group (sepsis) and two (1%) in the pomalidomide-dexamethasone group (pneumonia and urinary tract infection). INTERPRETATION: The addition of isatuximab to pomalidomide-dexamethasone significantly improves progression-free survival in patients with relapsed and refractory multiple myeloma. Isatuximab is an important new treatment option for the management of relapsed and refractory myeloma, particularly for patients who become refractory to lenalidomide and a proteasome inhibitor. FUNDING: Sanofi. VIDEO ABSTRACT.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc20005688
003      
CZ-PrNML
005      
20200525100723.0
007      
ta
008      
200511s2019 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1016/S0140-6736(19)32556-5 $2 doi
035    __
$a (PubMed)31735560
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Attal, Michel $u Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France. Electronic address: attal.michel@iuct-oncopole.fr.
245    10
$a Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study / $c M. Attal, PG. Richardson, SV. Rajkumar, J. San-Miguel, M. Beksac, I. Spicka, X. Leleu, F. Schjesvold, P. Moreau, MA. Dimopoulos, JS. Huang, J. Minarik, M. Cavo, HM. Prince, S. Macé, KP. Corzo, F. Campana, S. Le-Guennec, F. Dubin, KC. Anderson, ICARIA-MM study group,
520    9_
$a BACKGROUND: Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and dexamethasone compared with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma. METHODS: We did a randomised, multicentre, open-label, phase 3 study at 102 hospitals in 24 countries in Europe, North America, and the Asia-Pacific regions. Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor. Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody. We randomly assigned patients (1:1) to either isatuximab 10 mg/kg plus pomalidomide 4 mg plus dexamethasone 40 mg (20 mg for patients aged ≥75 years), or pomalidomide 4 mg plus dexamethasone 40 mg. Randomisation was done using interactive response technology and stratified according to the number of previous lines of treatment (2-3 vs >3) and age (<75 years vs ≥75 years). Treatments were assigned based on a permuted blocked randomisation scheme with a block size of four. The isatuximab-pomalidomide-dexamethasone group received isatuximab intravenously on days 1, 8, 15, and 22 in the first 28-day cycle, then on days 1 and 15 in subsequent cycles. Both groups received oral pomalidomide on days 1 to 21 in each cycle, and oral or intravenous dexamethasone on days 1, 8, 15, and 22 of each cycle. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal. Dose reductions for adverse reactions were permitted for pomalidomide and dexamethasone, but not for isatuximab. The primary endpoint was progression-free survival, determined by an independent response committee and assessed in the intention-to-treat population. Safety was assessed in all participants who received at least one dose of study drug. This study is registered at ClinicalTrials.gov, number NCT02990338. FINDINGS: Between Jan 10, 2017, and Feb 2, 2018, we randomly assigned 307 patients to treatment: 154 to isatuximab-pomalidomide-dexamethasone, and 153 to pomalidomide-dexamethasone. At a median follow-up of 11·6 months (IQR 10·1-13·9), median progression-free survival was 11·5 months (95% CI 8·9-13·9) in the isatuximab-pomalidomide-dexamethasone group versus 6·5 months (4·5-8·3) in the pomalidomide-dexamethasone group; hazard ratio 0·596, 95% CI 0·44-0·81; p=0·001 by stratified log-rank test. The most frequent treatment-emergent adverse events (any grade; isatuximab-pomalidomide-dexamethasone vs pomalidomide-dexamethasone) were infusion reactions (56 [38%] vs 0), upper respiratory tract infections (43 [28%] vs 26 [17%]), and diarrhoea (39 [26%] vs 29 [20%]). Adverse events with a fatal outcome were reported in 12 patients (8%) in the isatuximab-pomalidomide-dexamethasone group and 14 (9%) in the pomalidomide-dexamethasone group. Deaths due to treatment-related adverse events were reported for one patient (<1%) in the isatuximab-pomalidomide-dexamethasone group (sepsis) and two (1%) in the pomalidomide-dexamethasone group (pneumonia and urinary tract infection). INTERPRETATION: The addition of isatuximab to pomalidomide-dexamethasone significantly improves progression-free survival in patients with relapsed and refractory multiple myeloma. Isatuximab is an important new treatment option for the management of relapsed and refractory myeloma, particularly for patients who become refractory to lenalidomide and a proteasome inhibitor. FUNDING: Sanofi. VIDEO ABSTRACT.
650    _2
$a senioři $7 D000368
650    _2
$a monoklonální protilátky $x aplikace a dávkování $7 D000911
650    _2
$a protokoly protinádorové kombinované chemoterapie $x terapeutické užití $7 D000971
650    _2
$a dexamethason $x aplikace a dávkování $7 D003907
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a mnohočetný myelom $x farmakoterapie $7 D009101
650    _2
$a lokální recidiva nádoru $x farmakoterapie $7 D009364
650    _2
$a doba přežití bez progrese choroby $7 D000077982
650    _2
$a thalidomid $x aplikace a dávkování $x analogy a deriváty $7 D013792
650    _2
$a výsledek terapie $7 D016896
651    _2
$a Asie $7 D001208
651    _2
$a Evropa $7 D005060
651    _2
$a Severní Amerika $7 D009656
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a srovnávací studie $7 D003160
655    _2
$a časopisecké články $7 D016428
655    _2
$a multicentrická studie $7 D016448
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
655    _2
$a audiovizuální média $7 D059040
700    1_
$a Richardson, Paul G $u Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: paul_richardson@dfci.harvard.edu.
700    1_
$a Rajkumar, S Vincent $u Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.
700    1_
$a San-Miguel, Jesus $u Clinical and Translational Medicine, Clínica Universidad de Navarra, Navarra, CIMA, IDISNA, CIBER-ONC, Pamplona, Spain.
700    1_
$a Beksac, Meral $u Department of Hematology, Ankara University, Ankara, Turkey.
700    1_
$a Spicka, Ivan $u 1st Department of Medicine, Department of Hematology, First Faculty of Medicine Charles University and General Hospital in Prague, Prague, Czech Republic.
700    1_
$a Leleu, Xavier $u Department of Haematology, CHU La Milétrie-Poitiers, Poitiers, France.
700    1_
$a Schjesvold, Fredrik $u Oslo Myeloma Center, Oslo University Hospital, Oslo, Norway; KG Jebsen Center for B cell malignancies, University of Oslo, Oslo, Norway.
700    1_
$a Moreau, Philippe $u Hematology Department, CHU Nantes, Nantes, France.
700    1_
$a Dimopoulos, Meletios A $u Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece.
700    1_
$a Huang, Jeffrey Shang-Yi $u Department of Hematology, National Taiwan University Hospital, Taiwan.
700    1_
$a Minarik, Jiri $u Department of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.
700    1_
$a Cavo, Michele $u Department of Experimental, Diagnostic and Specialty Medicine, Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.
700    1_
$a Prince, H Miles $u Cancer Immunology and Molecular Oncology, Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia.
700    1_
$a Macé, Sandrine $u Sanofi Research And Development, Vitry-Sur-Seine, France.
700    1_
$a Corzo, Kathryn P $u Sanofi-Genzyme Oncology, Cambridge, MA, USA.
700    1_
$a Campana, Frank $u Sanofi-Genzyme Oncology, Cambridge, MA, USA.
700    1_
$a Le-Guennec, Solenn $u Sanofi Research And Development, Vitry-Sur-Seine, France.
700    1_
$a Dubin, Franck $u Sanofi Research And Development, Vitry-Sur-Seine, France.
700    1_
$a Anderson, Kenneth C $u Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
710    2_
$a ICARIA-MM study group
773    0_
$w MED00010161 $t Lancet (London, England) $x 1474-547X $g Roč. 394, č. 10214 (2019), s. 2096-2107
856    41
$u https://pubmed.ncbi.nlm.nih.gov/31735560 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20200511 $b ABA008
991    __
$a 20200525100723 $b ABA008
999    __
$a ok $b bmc $g 1524546 $s 1095744
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2019 $b 394 $c 10214 $d 2096-2107 $e 20191114 $i 1474-547X $m Lancet $n Lancet $x MED00010161
LZP    __
$a Pubmed-20200511

Najít záznam

Citační ukazatele

Možnosti archivace