FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior therapies included: stem cell transplant (55%), bortezomib (70%) melphalan (65%), thalidomide (48%), and lenalidomide (6%).
Maltese: It-terapiji ta' qabel inkludew: trapjant ta' ċelloli staminali (55%), bortezomib (70%) melphalan (65%), thalidomide (48%), u lenalidomide (6%).
English: Renal function Baseline CrCl < 60 mL/min Baseline CrCl ≥ 60 mL/min
Maltese: Indeboliment tal-kliewi CrCl tal-linja bażi < 60 mL/min CrCl tal-linja bażi ≥ 60 mL/min
English: The active substance is elotuzumab.
Maltese: Is-sustanza attiva hi elotuzumab.
English: Excipients: sucrose, sodium citrate, citric acid monohydrate, and polysorbate 80.
Maltese: Eċċipjenti: sucrose, sodium citrate, citric acid monohydrate, u polysorbate 80.
English: HR (95% CI): 0.54 (0.34, 0.86) p-value: 0.0078
Maltese: HR (95% CI): 0.54 (0.34, 0.86) valur-p: 0.0078
English: Overall Response (ORR)c n (%)
Maltese: Rispons Globali (ORR)c n (%)
English: HR (97.61% CI): 0.68 (0.55, 0.85) p-value: 0.0001
Maltese: HR (97.61% CI): 0.68 (0.55, 0.85) valur-p: 0.0001
English: H2 blocker: ranitidine (50 mg intravenous or 150 mg orally) or equivalent H2 blocker.
Maltese: Imblokkatur H2: ranitidine (50 mg ġol-vina jew 150 mg mill-ħalq) jew imblokkatur H2 ekwivalenti.
English: Elotuzumab is an immunostimulatory humanised, IgG1 monoclonal antibody that specifically targets the SLAMF7 (signaling lymphocyte activation molecule family member 7) protein.
Maltese: Elotuzumab huwa antikorp immunostimulatorju umanizzat, IgG1 monoklonali li jimmira speċifikament il-proteina molekula ta' sinjalar tal-attivazzjoni tal-limfoċiti membru tal-familja 7 (signaling lymphocyte activation molecule family member 7, SLAMF7).
English: The International Staging System (ISS) Stage was I in 50%, II in 38% and III in 12% of patients.
Maltese: L-Istadju tas-Sistema ta' Fażijiet Internazzjonali (International Staging System, ISS) kien I f'50 %, II fi 38 % u III fi 12 % tal-pazjenti.
English: Belgique/België/Belgien N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Maltese: België/Belgique/Belgien N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: Other symptoms may occur as well.
Maltese: Jista' jkun hemm sintomi oħra wkoll.
English: Rate (incidence rate/100 patient years)
Maltese: Rata (rata ta' inċidenza/ 100 sena ta' pazjent)
English: Bristol-Myers Squibb Company 38 Jackson Road, Devens MA 01434
Maltese: Bristol-Myers Squibb Company 38 Jackson Road, Devens
English: In cycles 1 and 2, once weekly on days 1, 8, 15, and 22.
Maltese: F'ċikli 1 u 2, darba fil-ġimgħa fil-jiem 1, 8, 15, u 22.
English: Table 10: CA204125 Efficacy results
Maltese: Tabella 7: CA204125
English: PFS ITT assessment per investigator was evaluated in several subgroups including age (< 65 versus ≥ 65), race, ISS stage, prior therapies, transplant, risk category, ECOG status, creatinine clearance, and cytogenic abnormalities.
Maltese: Il-valutazzjoni tal-PFS ITT skont l-investigatur ġiet evalwata f'diversi sottogruppi inkluż età (< 65 kontra ≥ 65), razza, stadju ISS, terapiji preċedenti, trapjant, kategorija tar-riskju, status ECOG, tneħħija tal-kreatinina, u anormalitajiet ċitoġeniċi.
English: Figure 3: CA204125 Progression free survival per investigator
Maltese: Figura 3: CA204125 Sopravivenza mingħajr progressjoni skont l-investigatur
English: E-Pd 60 48 43 37 32 25 7 1 1 1 1
Maltese: E-Pd 60 48 43 37 32 25 7 1 1 1 1 Pd 57 42 31 22 16 10 6 2 1
English: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057
Maltese: Thompson Road, East Syracuse New York 13057
English: Absence of del17p Presence of t(4;14) Absence of t(4;14) ISS Stage I
Maltese: Nuqqas ta' del17p Preżenza ta' t(4;14) Nuqqas ta' t(4;14) Fażi
English: The International Staging System (ISS) Stage was I in 43%, II in 32% and III in 21% of patients.
Maltese: L-Istadju tas-Sistema ta' Fażijiet Internazzjonali (International Staging System, ISS) kien I fi 43%, II fi 32% u III f'21% tal-pazjenti.
English: The high risk cytogenetic categories of del17p and t(4;14) were present in 32% and 9% of patients, respectively.
Maltese: Il-kategoriji ċitoġenetiċi ta' riskju għoli ta' del17p u t(4;14) kienu preżenti fi 32% u 9% tal-pazjenti, rispettivament.
English: The chromosomal abnormalities as determined by the FISH of del(17p), t(4;14) and t(14;16) were present in 5%, 11%
Maltese: L-anormalitajiet kromożomali kif iddeterminat minn FISH ta' del(17p), t(4;14) u t(14;16) kienu preżenti f'5 %, 11 % u 7 % tal-pazjenti, rispettivament.
English: How to store Empliciti 6.
Maltese: Kif taħżen Empliciti 6.
English: Cycle 1, Dose 2
Maltese: Ċiklu 1, Doża 2
English: Premedication consisting of dexamethasone, H1 blocker, H2 blocker, and paracetamol must be administered prior to Empliciti infusion (see section 4.2 Premedication).
Maltese: Premedikazzjoni li tikkonsisti minn dexamethsaone, imblokkatur H1, imblokkatur H2, u paracetamol għandha tingħata qabel l-infużjoni ta' Empliciti (ara sezzjoni 4.2 Premedikazzjoni).
English: The minimum follow-up was 70.6 months.
Maltese: Is-segwitu minimu kien 70.6 xhur.
English: Dexamethasone was administered on day 1, 8, 15 and 22 of each cycle.
Maltese: Dexamethasone ngħata f'jum 1, 8, 15 u 22 ta' kull ċiklu.
English: The OS data from the exploratory analysis were not mature at the data cut-off (29 November 2018) with a minimum follow up of 18.3 months.
Maltese: Id-data tal-OS millanaliżi esploratorja ma kinitx matura fil-cut-off tad-data (29 ta' Novembru 2018) b'segwitu minimu ta' 18.3 xhur.
English: All reports of infusion reaction were ≤ Grade 3.
Maltese: Ir-rapporti kollha tar-reazzjoni għallinfużjoni kienu ≤ Grad 3.
English: A pre-specified final analysis for OS was performed based on at least 427 deaths with a minimum follow-up time of 70.6 months.
Maltese: Analiżi finali pre-speċifikata għal OS twettqet abbażi ta' mill-inqas 427 mewt bi żmien ta' segwitu minimu ta' 70.6 xhur.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Empliciti contains sodium
Maltese: Empliciti fih is-sodium
English: The 1-, 2-, 3-, 4- and 5-year rates of overall survival for Empliciti in combination with lenalidomide and dexamethasone treatment were 91%, 73%, 60%, 50% and 40% respectively, compared with 83%, 69%, 53%, 43% and 33% respectively, for lenalidomide and dexamethasone treatment (See Figure 2).
Maltese: Ir-rati ta' sopravivenza globali ta' sena, sentejn, 3, 4 u 5 snin għal Empliciti flimkien mal-kura b'lenalidomide u dexamethasone kienu ta' 91%, 73%, 60%, 50% u 40% rispettivament, meta mqabbla ma' 83%, 69%, 53%, 43% u 33% rispettivament, għall-kura b'lenalidomide u dexamethasone (Ara Figura 2).
English: b modified International Myeloma Working Group (IMWG) criteria.
Maltese: b kriterji tal-Grupp ta' Ħidma Internazzjonali tal-Majeloma (IMWG) modifikati.
English: Kaplan-Meier curve for PFS per the investigator is provided in Figure 3.
Maltese: Il-kurva ta' Kaplan Meier għall-PFS skont l-investigatur hija pprovduta f'Figura 3.
English: The geometric mean volume of distribution of elotuzumab at the recommended dosing regimen in combination with lenalidomide/dexamethasone or pomalidomide/dexamethasone at steady state is 5.7 L (CV: 23%) and 5.6 L (CV: 21%) respectively.
Maltese: Il-volum medju ġeometriku tad-distribuzzjoni ta' elotuzumab bil-kors tad-dożaġġ rakkomandat flimkien ma' lenalidomide/dexamethasone jew pomalidomide/dexamethasone fi stat fiss huwa 5.7 L (CV: 23%) u 5.6 L (CV: 21%) rispettivament.
English: Dose delay, interruption, or discontinuation
Maltese: Posponiment, interruzzjoni, jew twaqqif tad-doża
English: Prior bortezomib exposure No prior bortezomib exposure
Maltese: Ebda espożizzjoni preċedenti għal bortezomib
English: The pharmacokinetics (PK) of elotuzumab was studied in patients with multiple myeloma.
Maltese: Il-farmakokinetika (pharmacokinetics, PK) ta' elotuzumab ġiet studjata f'pazjenti b'majeloma multipla.
English: EU/1/16/1088/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1088/001-002
English: Figure 2: CA204004 Overall survival
Maltese: Figura 2: CA204004 Sopravivenza globali
English: As with all therapeutic proteins, there is a potential for immunogenicity to Empliciti.
Maltese: Bħal kull proteina terapewtika, hemm potenzjal għall-immunoġeniċità għal Empliciti.
English: As Empliciti will be given to you by a healthcare professional, it is unlikely you will be given too much.
Maltese: Peress li Empliciti ser jingħata minn professjonist fil-kura tas-saħħa, huwa improbabbli li ser tingħata wisq.
English: Lenalidomide and Dexamethasone N = 317
Maltese: Lenalidomide u Dexamethasone N = 317
English: 0.0408h
Maltese: MA 01434
English: Premedication for prevention of infusion reaction Patients must be administered with the following premedications 45-90 minutes prior to Empliciti infusion (see section 4.4): Dexamethasone 8 mg intravenous H1 blocker: diphenhydramine (25-50 mg orally or intravenous) or equivalent H1 blocker.
Maltese: Premedikazzjoni għall-prevenzjoni ta' reazzjoni għall-infużjoni Il-pazjenti għandhom jingħataw il-premedikazzjonijiet li ġejjin 45-90 minuta qabel l-infużjoni ta' Empliciti (ara sezzjoni 4.4): Dexamethasone 8 mg ġol-vina Imblokkatur H1: diphenhydramine (25-50 mg mill-ħalq jew ġol-vina) jew imblokkatur H1 ekwivalenti.
English: A total of 117 patients were randomised in a 1:1 ratio to receive treatment: 60 to elotuzumab in combination with pomalidomide and dexamethasone (E-Pd) and 57 to pomalidomide and dexamethasone (Pd).
Maltese: Total ta' 117-il pazjent ġew randomizzati fi proporzjon ta' 1:1 biex jirċievu l-kura: 60 għal elotuzumab flimkien ma' pomalidomide u dexamethasone (E-Pd) u 57 għal pomalidomide u dexamethasone (Pd).
English: IRC assessment was performed post-hoc.
Maltese: Il-valutazzjoni tal-IRC saret post-hoc.
English: Empliciti + Pomalidomide and Dexamethasone N = 60
Maltese: Empliciti + Pomalidomide u Dexamethasone N = 60
English: Pomalidomide and Dexamethasone N = 55
Maltese: Pomalidomide u Dexamethasone N = 55
English: Table 2: Recommended dosing schedule of Empliciti in combination with pomalidomide and dexamethasone
Maltese: Tabella 2: Skeda tad-dożi rakkomandata ta' Empliciti flimkien ma' pomalidomide u dexamethasone
English: Final volume of reconstituted Empliciti in the vial (including volume displaced by the solid cake)
Maltese: Volum finali ta' Empliciti rikostitwit filkunjett (inkluż il-volum spostat mill-kejk solidu)
English: The median PFS per ITT was 10.25 months (95% CI: 5.59, NE) in the E-Pd arm and 4.67 months (95% CI: 2.83, 7.16) in the Pd arm. PFS and ORR were also assessed by the IRC.
Maltese: 25 xhur (95% CI: 5.59, NE) fil-fergħa ta' E-Pd u 4.67 xhur(95% CI: 2.83, 7.16) 56fil-fergħa ta' Pd. Il-PFS u l-ORR ġew ivvalutati wkoll mill-IRC.
English: The safety data of elotuzumab have been assessed from a total of 682 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone (451 patients), bortezomib and dexamethasone (103 patients) or pomalidomide and dexamethasone (128 patients) pooled across 8 clinical trials.
Maltese: Id-dejta ta' sigurtà ta' elotuzumab ġiet ivvalutata minn total ta' 682 pazjent b'majeloma multipla kkurata b'elotuzumab flimkien ma' lenalidomide u dexamethasone (451 pazjent), bortezomib u dexamethasone (103 pazjenti) jew pomalidomide u dexamethasone (128 pazjent) fi 8 provi kliniċi.
English: Empliciti should be initiated at an infusion rate of 0.5 mL/min for 10 mg/kg dose and 3 mL/min for 20 mg/kg dose.
Maltese: Empliciti għandu jiġi injettat b'rata ta' infużjoni ta' 0.5 mL/min għal doża ta' 10 mg/kg u 3 mL/min għal doża ta' 20 mg/kg.
English: Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for the treatment groups.
Maltese: Irrispettivament mis-sottogrupp evalwat, il-PFS ġeneralment kienet konsistenti ma' dik li ġiet osservata fil-popolazzjoni ITT għall-gruppi tal-kura.
English: Cycle 1, Dose 1
Maltese: Ċiklu 1, Doża 1
English: Neutralizing antibodies were detected in 19 of 299 patients in CA204004.
Maltese: Antikorpi li jinnewtralizzaw kienu rilevati f'19 minn 299 pazjent f'CA204004.
English: Elotuzumab also targets SLAMF7 on myeloma cells and through interactions with Fc receptors on specific immune cells, promotes the killing of myeloma cells through NK cell-mediated antibody-dependent cellular cytotoxicity (ADCC) and macrophage-mediated antibody-dependant cellular phagocytosis (ADCP).
Maltese: Elotuzumab jimmira wkoll speċifikament SLAMF7 fiċ-ċelloli tal-majeloma u permezz ta' interazzjonijiet ma' riċetturi Fc fuq ċelloli immuni speċifiċi,jippromwovi l-qtil ta' ċelloli tal-majeloma permezz ta' ċitotossiċità ċellulari li tiddependi fuq l-antikorp (antibody-dependent cellular cytotoxicity, ADCC) medjata miċ-ċellola NK u fagoċitożi ċellulari li tiddependi fuq l-antikorp (antibody-dependant cellular phagocytosis, ADCP) medjata mill-makrofaġu.
English: Neutralizing antibodies were detected in 2 of 53 patients.
Maltese: L-antikorpi newtralizzanti ġew identifikati fi 2 minn 53 pazjent.
English: Empliciti + Lenalidomide and Dexamethasone N = 318
Maltese: Empliciti + Lenalidomide u Dexamethasone N = 318
English: The effect of renal impairment on the pharmacokinetics of elotuzumab was evaluated in patients with normal renal function (CrCl > 90 mL/min; N = 8), severe renal impairment not requiring dialysis (CrCl <30 mL/min; N = 9), or end-stage renal disease requiring dialysis (CrCl < 30 mL/min; N = 9).
Maltese: L-effett ta' indeboliment tal-kliewi fuq ilfarmakokinetika ta' elotuzumab kien evalwat f'pazjenti b'funzjoni tal-kliewi normali (CrCl > 90 mL/min; N = 8), indeboliment tal-kliewi sever li ma jeħtieġx dijaliżi (CrCl < 30 mL/min; N = 9), jew marda tal-kliewi fl-aħħar stadju li teħtieġ dijaliżi (CrCl < 30 mL/min; N = 9).
English: 28-Day Cycles 3+ Day of Cycle 1 8 15 22 1 8 15 22
Maltese: Jum taċ-Ċiklu 1 8 15 22 1 8 15 22
English: Table 1: Reconstitution instructions
Maltese: Tabella 1: Struzzjonijiet ta' rikostituzzjoni
English: Pharmacokinetic interaction studies have not been conducted.
Maltese: Ma twettqux studji dwar interazzjonijiet farmakokinetici.
English: The median number of prior therapies was 2.
Maltese: In-numru medjan ta' terapiji preċedenti kien 2.
English: SLAMF7 is also expressed on natural killer cells (NK), normal plasma cells, and other immune cells including some T cell subsets, monocytes, B cells, macrophages, and pDCs (plasmacytoid dendritic cells), but is not detected on normal solid tissues or haematopoietic stem cells.
Maltese: SLAMF7 tinstab ukoll f'ċelloli qattiela naturali (NK), ċelloli tal-plażma normali, u ċelloli immuni oħrajn inkluż xi subsettijiet ta' ċelloli T, monoċiti, ċelloli B, makrofaġi u pDCs (ċelloli dendtriċi plasmaċitodji), iżda ma tinstabx f'tessuti solidi normali jew ċelloli staminali emopoetiċi.
English: If symptoms do not recur, the infusion rate may be gradually escalated every 30 minutes to a maximum of 5 mL/min (see section 4.2 Method of administration).
Maltese: Jekk is-sintomi ma jerġgħux iseħħu, ir-rata tal-infużjoni tista' tiġi eskalata gradwalment kull 30 minuta għal massimu ta' 5 mL/min (ara sezzjoni 4.2 Metodu ta' kif għandu jingħata).
English: Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy).
Maltese: Ħamsa u tletin fil-mija (35%) tal-pazjenti kienu refrattarji (progress matul jew sa 60 jum mill-aħħar terapija) u 65% kellhom rikaduta (progressjoni wara 60 jum mill-aħħar terapija).
English: Table 8: CA204004 Efficacy results
Maltese: Tabella 8: CA204004
English: E-Ld 321 282 240 206 164 133 87 43 12 1
Maltese: E-Ld 321 282 240 206 164 133 87 43 12 1 Ld 325 262 204 168 130 97 53 24 7
English: The most common adverse reactions (occurring in > 10% of patients) with elotuzumab treatment were infusion related reactions, diarrhoea, herpes zoster, nasopharyngitis, cough, pneumonia, upper respiratory tract infection, lymphopenia and weight decreased.
Maltese: L-aktar reazzjonijiet avversi komuni (li jseħħu f'> 10% tal-pazjenti) bil-kura permezz ta' elotuzumab kienu reazzjonijiet relatati ma' infużjoni, dijarea, herpes zoster, nasofarinġite, sogħla, pnewmonja, infezzjoni tan-naħa ta' fuq tal-apparat respiratorju, limfopenija u tnaqqis fil-piż.
English: SLAMF7 is highly expressed on multiple myeloma cells independent of cytogenetic abnormalities.
Maltese: SLAMF7 tinstab fi kwantità għolja f'ċelloli tal-majeloma multipla indipendentement minn anormalitajiet ċitoġenetiċi.
English: The reconstituted solution should be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose injection to obtain a final infusion concentration range between 1 mg/mL and 6 mg/mL.
Maltese: Is-soluzzjoni rikostitwita għandha tiġi dilwita b'sodium chloride 9 mg/mL (0.9%) soluzzjoni għallinjezzjoni jew injezzjoni ta' 5% glucose sabiex tinkiseb medda tal-konċentrazzjoni tal-infużjoni finali bejn 1 mg/mL u 6 mg/mL.
English: Eleven (9.4%) patients had high-risk myeloma.
Maltese: Ħdax (9.4%)-il pazjent kellhom majeloma ta' riskju għoli.
English: Subset description
Maltese: Deskrizzjoni ta' subsett
English: In nonclinical models, elotuzumab has demonstrated synergistic activity when combined with lenalidomide, pomalidomide or bortezomib.
Maltese: F'mudelli mhux kliniċi, elotuzumab wera attività sinerġistika meta kkombinat ma' lenalidomide, pomalidomide jew bortezomib.
English: Lymphopeniac
Maltese: Limfopenjac
English: Figure 1: CA204004 Progression free survival
Maltese: Figura 1: CA204004 Sopravivenza mingħajr progressjoni
English: The other ingredients (excipients) are sucrose, sodium citrate (see section 2 “Empliciti contains sodium”), citric acid monohydrate, and polysorbate 80.
Maltese: Is-sustanzi mhux attivi l-oħra (eċċipjenti) huma sucrose, sodium citrate (ara sezzjoni 2 “Empliciti fih is-sodium”), citric acid monohydrate, u polysorbate 80.
English: Grade 3/4 frequency
Maltese: Frekwenza ta' Grad 3/4
English: Very Good Partial Response (VGPR) n (%) Partial Response (RR/PR) n (%) Combined Responses (CR+sCR+VGPR) n (%) 12 (20.0)
Maltese: Rispons Parzjali Tajjeb Ħafna (Very Good Partial Response, VGPR) n (%) Rispons Parzjali (RR/PR) n (%) Risponsi Kombinati (CR+sCR+VGPR) n (%)
English: Table 1: Recommended dosing schedule of Empliciti in combination with lenalidomide and dexamethasone
Maltese: Tabella 1: Skeda tad-dożi rakkomandata ta' Empliciti flimkien ma' lenalidomide u dexamethasone
English: The metabolic pathway of elotuzumab has not been characterized.
Maltese: Il-passaġġ metaboliku għal elotuzumab ma ġiex ikkaratterizzat.
English: Stratified log-rank test p-valuea 1-Year PFS rate (%) [95% CI] 2-Year PFS rate (%) [95% CI] 3-Year PFS rateb(%) [95% CI] Median PFS in months [95% CI]
Maltese: Valur-p tat-test log-rank stratifikata Rata PFS ta' Sena (%) [95% CI] Rata PFS ta' Sentejn (%)
English: Cycle 1, Dose 3 and 4 and all subsequent Cycles
Maltese: Ċiklu 1, Doża 3 u 4 u kull Ċiklu sussegwenti
English: Cougha
Maltese: Qawwa
English: In a clinical trial of patients with multiple myeloma (CA204125), infections were reported in 65% of patients in the Empliciti combined with pomalidomide and dexamethasone arm (N = 60) and 65.5% in the pomalidomide and dexamethasone arm (N = 55).
Maltese: Fi prova klinika ta' pazjenti b'majeloma multipla (CA204125), ġew irrappurtati infezzjonijiet f'65 % tal-pazjenti fil-fergħa ta' Empliciti flimkien ma' pomalidomide u dexamethasone (N = 60) u 65.5 % filfergħa ta' pomalidomide u dexamethasone(N = 55).
English: PFS (ITT)
Maltese: PFS medjan (xhur)
English: Improvements observed in PFS were consistent across subsets regardless of age (< 65 versus ≥ 65), risk status, presence or absence of cytogenetic categories del17p or t(4;14), ISS stage, number of prior therapies, prior immunomodulatory exposure, prior bortezomib exposure, relapsed or refractory status or renal function as shown in Table 9.
Maltese: It-titjib osservat fil-PFS kien konsistenti fis-subsettijiet kollha irrispettivament mill-età (< 65 kontra ≥ 65), l-istatus tar-riskju, il-preżenza jew in-nuqqas ta' kategoriji ċitoġenetiċi del17p jew t(4;14), listadju ISS, in-numru ta' terapiji ta' qabel, l-espożizzjoni immunomodulatorja ta' qabel, l-espożizzjoni ta' qabel għal bortezomib, l-istatus rikadut jew refrattarju, jew il-funzjoni tal-kliewi kif muri fitTabella 9.
English: a p-value based on the log-rank test stratified by B2 microglobulins (<3.5 mg/L versus ≥ 3.5 mg/L), number of prior lines of therapy (1 versus 2 or 3), and prior immunomodulatory therapy (no versus prior thalidomide only versus other).
Maltese: B2 (< 3.5 mg/L kontra ≥ 3.5 mg/L), numru ta' linji ta' terapija ta' qabel (1 kontra 2 jew 3), u terapija immunomodulatorja ta' qabel (l-ebda terapija b'thalidomide ta' qabel, kontra terapiji oħrajn biss).
English: An open-label study (CA204007) evaluated the pharmacokinetics of elotuzumab in combination with lenalidomide and dexamethasone in patients with multiple myeloma with varying degrees of renal impairment (classified using the CrCl values).
Maltese: Studju b'tikketta mikxufa (CA204007) evalwa l-farmakokinetika ta' elotuzumab flimkien ma' lenalidomide u dexamethasone f'pazjenti b'majeloma multipla b'diversi gradi ta' indeboliment talkliewi (klassifikat permezz ta' valuri CrCL).
English: Population PK analysis suggested that the following factors had no clinically important effect on the clearance of elotuzumab: age, gender, race, baseline LDH, albumin, renal impairment, mild hepatic impairment, and coadministration with lenalidomide/dexamethasone or pomalidomide/dexamethasone.
Maltese: L-analiżi PK talpopolazzjoni ssuġġeriet li l-fatturi li ġejjin ma kellhom l-ebda effett klinikament importanti fuq ittneħħija ta' elotuzumab: età, sess, razza, LDH fil-linja bażi, albumina, indeboliment tal-kliew, u indebolimen tal-fwied ħafif, u għoti flimkien ma' lenalidomide/dexamethasone jew pomalidomide/dexamethasone.
English: Upon discontinuation of elotuzumab in combination with lenalidomide and dexamethasone or in combination with pomalidomide and dexamethasone, concentrations of elotuzumab will decrease to approximately 3% (approximately 97% washout as estimated by 5 half-lives) of the population predicted steady-state maximal serum concentration by 3 months.
Maltese: Meta jitwaqqaf elotuzumab, f'kombinazzjoni ma' lenalidomide u dexamethasone jew flimkien ma' pomalidomide u dexamethasone, il-konċentrazzjonijiet ta' elotuzumab jonqsu għal bejn wieħed u ieħor 3% (bejn wieħed u ieħor 97% ta' tneħħija mill-ġisem kif stmat minn 5 half-lives) tal-konċentrazzjoni massima fis-serum fi stat fiss mbassra mill-popolazzjoni.
English: No dose adjustment of Empliciti is required for patients with mild (CrCl = 60 - 89 mL/min), moderate (CrCl = 30 - 59 mL/min), severe (CrCl < 30 mL/min) renal impairment or end stage renal disease requiring dialysis (see section 5.2).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ għal Empliciti għal pazjenti b'indeboliment tal-kliewi ħafif (CrCl = 60 - 89 mL/min), moderat (CrCl = 30 - 59 mL/min), sever (CrCl < 30 mL/min) jew mard talkliewi fl-istadju finali li jeħtieġ dijaliżi (ara sezzjoni 5.2).
English: Empliciti may be detected in the serum protein electrophoresis (SPEP) and serum immunofixation assays of myeloma patients and could interfere with correct response classification.
Maltese: Empliciti jista' jinstab fl-elettroforeżi tal-proteina fis-serum (serum protein electrophoresis, SPEP) u lassaġġi ta' immunofissazzjoni fis-serum ta' pazjenti b'majeloma u jista' jinterferixxi malklassifikazzjoni ta' rispons korrett.
English: Median PFS (months) [95% CI]
Maltese: PFS medjana f'xhur [95% CI]