natgillin/translations-raw huggingface dataset:
ª The median is based on the Kaplan-Meier estimate ¤PFS2 (an exploratory endpoint) was defined for all patients (ITT) as time from randomisation to start of 3rd line antimyeloma therapy (AMT) or death for all randomised patients
¤ PFS2 (končni cilj raziskave) je bilo definirano za vse bolnike (ITT) kot čas od randomizacije do začetka 3. linije zdravljenja plazmocitoma
After 3 cycles of lenalidomide maintenance, the dose can be increased to 15 mg orally once daily if tolerated.
Po 3 ciklih vzdrževalnega zdravljenja z lenalidomidom se lahko odmerek zveča na 15 mg peroralno enkrat na dan, če ga bolnik prenaša.
• do not break, open or chew the capsules.
• Kapsul ne drobite, odprite ali žvečite.
The serious adverse reactions observed more frequently (≥5%) with lenalidomide in combination with low dose dexamethasone (Rd and Rd18) than with melphalan, prednisone and thalidomide (MPT) were:
Resna neželena učinka, ki so ju opazili pogosteje (≥ 5 %) pri lenalidomidu v kombinaciji z deksametazonom v majhnem odmerku (Rd in Rd18) kot pri melfalanu, prednizonu in talidomidu (MPT), sta bila:
Overall survival Median [95% CI], weeks 1-year Overall survival rate
Mediana celokupnega preživetja [95 % IZ], tedni 1-letna stopnja celokupnega preživetja p = 0,045
• an immunosuppressant medicine called ‘prednisone'.
• zdravilom za zaviranje imunske odzivnosti, ki se imenuje ‘prednizon'.
This study investigated the use of combination therapy of MPR (melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles; prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles; and lenalidomide 10 mg/day orally on days 1 to 21 of repeated 28-day cycles) for induction therapy, up to 9 cycles.
V tej študiji so raziskovali uporabo kombinirane terapije z MPR (melfalan 0,18 mg/kg peroralno od 1. do 4. dne v ponavljajočih se 28-dnevnih ciklih; prednizon 2 mg/kg peroralno od 1. do 4. dne v ponavljajočih se 28-dnevnih ciklih; in lenalidomid 10 mg/dan peroralno od 1. do 21. dne v ponavljajočih se 28-dnevnih ciklih) za indukcijsko zdravljenje, do največ 9 ciklov.
Patients who complete 9 cycles or who are unable to complete the combination therapy due to intolerance are treated with lenalidomide monotherapy as follows: 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles given until disease progression.
Bolniki, ki dokončajo 9 ciklov ali ki niso sposobni dokončati kombiniranega zdravljenja zaradi intolerance, naj se zdravijo z monoterapijo z lenalidomidom, in sicer takole: 10 mg peroralno enkrat na dan od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih, ki ga dajemo do napredovanja bolezni.
The incidence rate of hematologic malignancies, most notably AML, MDS and B-cell malignancies (including Hodgkin's lymphoma), was 1.31 per 100 person-years for the lenalidomide arms and 0.58 per 100 person-years for the placebo arms (1.02 per 100 person-years for patients exposed to lenalidomide after ASCT and 0.60 per 100 person-years for patients not-exposed to lenalidomide after ASCT).
Stopnja incidence hematoloških malignosti, predvsem AML, MDS in malignosti celic B (vključno s Hodgkinovim limfomom), je bila 1,31 na 100 oseb-let v skupinah z lenalidomidom in 0,58 na 100 oseb-let v skupinah s placebom (1,02 na 100 oseb-let pri bolnikih, izpostavljenih lenalidomidu po ASCT, in 0,60 oseb-let pri bolnikih, neizpostavljenih lenalidomidu po ASCT).
Multiple myeloma - in patients who have had treatment before Lenalidomide Accord is taken together with an anti-inflammatory medicine called ‘dexamethasone'.
Diseminirani plazmocitom - pri bolnikih, ki so se že prej zdravili Zdravilo Lenalidomide Accord se jemlje skupaj s protivnetnim zdravilom, ki se imenuje ‘deksametazon'.
There is an increased risk of rhabdomyolysis when statins are administered with lenalidomide, which may be simply additive.
Kadar se statini dajejo skupaj z lenalidomidom, obstaja povečano tveganje za rabdomiolizo, ki se lahko enostavno prišteva.
Cases of AML have been observed in clinical trials of newly diagnosed multiple myeloma in patients taking lenalidomide treatment in combination with melphalan or immediately following HDM/ASCT (see section 4.4).
V kliničnih preskušanjih novo diagnosticiranega diseminiranega plazmocitoma so pri bolnikih, ki so se zdravili z lenalidomidom v kombinaciji z melfalanom ali takoj po HDM/ASCT, opazili primere AML (glejte poglavje 4.4).
Patients should not donate blood during therapy or for 1 week following discontinuation of lenalidomide.
Bolniki med zdravljenjem z lenalidomidom ali en teden po prekinitvi zdravljenja ne smejo darovati krvi.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Talidomid je znana za človeka teratogena učinkovina, ki povzroča hude, smrtno nevarne okvare ploda.
There are no phase III trial experiences with End Stage Renal Disease (ESRD) (CLcr < 30 mL/min, requiring dialysis).
Ni izkušenj iz preskušanj faze III pri končni ledvični odpovedi (ESRD - End Stage Renal Disease) (CLcr < 30 ml/min, dializa je potrebna).
Co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Pri sočasni uporabi lenalidomida in drugih mielosupresivnih zdravil moramo biti previdni.
Cases of allergic reaction/hypersensitivity reactions have been reported in patients treated with lenalidomide (see section 4.8).
Pri bolnikih, zdravljenih z lenalidomidom, so poročali o primerih alergijskih reakcij/preobčutljivostnih reakcij (glejte poglavje 4.8).
Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Grade 3 or 4 thrombocytopenia was observed to a lesser extent in the Rd and Rd18 arms than in the comparator arm (8.1% vs 11.1%, respectively).
Trombocitopenijo 3. ali 4. stopnje so opazili v manjši meri v skupinah z Rd in Rd18 kot v skupini s primerjalnim zdravilom (8,1 % v primerjavi z 11,1 %).
• Local country specific arrangements for a prescription for Lenalidomide Accord to be dispensed
• lokalne, za državo značilne dogovore glede predpisovanja in izdajanja zdravila Lenalidomide
Complete response and overall response rates in the len/dex arm were also significantly higher than the placebo/dex arm in both studies.
Pogostnost popolnega odgovora in celokupnega odgovora je bila v skupini len/deks v obeh študijah pomembno večja kot v skupini placebo/deks.
In total, 353 patients were evaluated in the MM-009 study; 177 in the len/dex group and 176 in the placebo/dex group and, in total, 351 patients were evaluated in the MM-010 study; 176 in the len/dex group and 175 in the placebo/dex group.
V študiji MM-009 so skupno ocenili 353 bolnikov; 177 v skupini len/deks in 176 v skupini placebo/deks.
• Understand that if his female partner becomes pregnant whilst he is taking lenalidomide or shortly after he has stopped taking lenalidomide , he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
• morajo razumeti, da je treba takoj obvestiti lečečega zdravnika, če njegova partnerica zanosi, medtem ko on jemlje lenalidomid ali kratek čas po tistem, ko preneha jemati lenalidomid, in da je priporočljivo napotiti partnerico k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji, zaradi ocene in svetovanja.
The following post-marketing adverse reactions have been reported (frequency unknown): acute hepatic failure and cholestasis (both potentially fatal), toxic hepatitis, cytolytic hepatitis, mixed cytolytic/cholestatic hepatitis.
Poročali so o naslednjih neželenih učinkih v obdobju trženja (z neznano pogostnostjo): akutna odpoved jeter in holestaza (oboje potencialno smrtno), toksični hepatitis, citolitični hepatitis in mešani citolitični/holestatski hepatitis.
The efficacy and safety of lenalidomide maintenance was assessed in two phase 3 multicenter, randomised, double-blind 2-arm, parallel group, placebo-controlled studies: CALGB 100104 and IFM
Učinkovitost in varnost vzdrževalnega zdravljenja z lenalidomidom so ocenili v dveh multicentričnih randomiziranih dvojno slepih študijah faze III z dvema skupinama in paralelnimi skupinami, kontroliranih s placebom: CALGB 100104 in IFM 2005-02.
The incidence rate of solid tumour SPMs was 1.36 per 100 person-years for the lenalidomide arms and 1.05 per 100 person-years for the placebo arms (1.26 per 100 person-years for patients exposed to lenalidomide after ASCT and 0.60 per 100 person-years for patients not-exposed to lenalidomide after ASCT).
Stopnja incidence SPM s čvrstimi tumorji je bila 1,36 na 100 oseb-let v skupinah z lenalidomidom in 1,05 na 100 oseb-let v skupinah s placebom (1,26 na 100 oseb-let pri bolnikih, izpostavljenih lenalidomidu po ASCT, in 0,60 oseb-let pri bolnikih, neizpostavljenih lenalidomidu po ASCT).
• Chest pain or leg pain
• bolečine v prsnem košu ali v nogah;
• That Lenalidomide Accord may cause venous and arterial thromboembolism
• opozorilo, da lahko zdravilo Lenalidomide Accord povzroči vensko ali arterijsko trombembolijo;
Lenalidomide Accord contains the active substance ‘lenalidomide'.
Zdravilo Lenalidomide Accord vsebuje učinkovino, ki se imenuje "lenalidomid".
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK Zdravilo shranjujte nedosegljivo otrokom!
If pregnancy occurs in a woman treated with lenalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če ženska, ki se zdravi z lenalidomidom, zanosi, je treba zdravljenje prekiniti, bolnico pa napotiti k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji zaradi ocene in svetovanja.
The Educational Healthcare Professional's Kit
Izobraževalni paket za zdravstvene delavce
• Darkening of your skin
• potemnitev kože;
It is important to note that a small number of patients may develop additional types of cancer, and it is possible that this risk may be increased with lenalidomide treatment, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed lenalidomide .
Možno je, da se to tveganje poveča pri zdravljenju z lenalidomidom, zato naj zdravnik skrbno oceni koristi in tveganja, ko vam predpiše lenalidomid.
T-cell type acute leukaemia◊, Basal cell carcinoma^,◊, Tumour lysis syndrome
občasni akutna T-celična levkemija◊, bazalnocelični karcinom^,◊, sindrom tumorske lize
• Pregnancy test regime o Before commencing treatment o During treatment, every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
• režim testov nosečnosti: o pred začetkom zdravljenja, o vsake 4 tedne med zdravljenjem razen v primeru potrjene sterilizacije jajcevodov, o po končanem zdravljenju;
If pregnancy occurs in a partner of a male patient taking lenalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Če zanosi partnerica moškega bolnika, ki se zdravi z lenalidomidom, je priporočljivo napotiti partnerico k zdravniku specialistu za teratologijo ali k zdravniku z izkušnjami v teratologiji zaradi ocene in svetovanja.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3).
Lenalidomid je povzročil pri opicah deformacije, ki so podobne deformacijam opisanim pri talidomidu (glejte poglavji 4.6 in 5.3).
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide in combination therapy, and to a lesser extent in patients with multiple myeloma, taking lenalidomide monotherapy, combined oral contraceptive pills are not recommended (see also section 4.5).
Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z diseminiranim plazmocitomom, ki jemljejo lenalidomid v okviru kombiniranega zdravljenja, in v manjšem obsegu pri bolnicah z diseminiranim plazmocitomom, ki se zdravijo z monoterapijo z lenalidomidom, uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočena (glejte tudi poglavje 4.5).
HR [95% CI]; p-value MPR+R vs MPp+p MPR+R vs MPR+p MPR+p vs MPp +p Follow-up (months) Median (min, max): all patients Investigator-assessed Myeloma response n (%) CR PR Stable Disease (SD) Response Not Evaluable (NE) Investigator-assessed Duration of response (CR+PR) (months) Mediana (95% CI)
HR [95 % IZ]; vrednost p MPR+R proti MPp+p MPR+R proti MPR+p MPR+p proti MPp +p Spremljanje (meseci) mediana (min, maks): vsi bolniki Odgovor plazmocitoma po oceni raziskovalca n (%) popolni odgovor (CR) delni odgovor (PR) stabilna bolezen (SD) odgovora ni mogoče oceniti (NE) Trajanje odgovora po oceni raziskovalca (CR+PR) (meseci) medianaa (95 % IZ)
Haemorrhagic disorders are listed under several system organ classes: Blood and lymphatic system disorders; nervous system disorders (intracranial haemorrhage); respiratory, thoracic and mediastinal disorders (epistaxis); gastrointestinal disorders (gingival bleeding, haemorrhoidal haemorrhage, rectal haemorrhage); renal and urinary disorders (haematuria); injury, poisoning and procedural complications (contusion) and vascular disorders (ecchymosis).
Krvavitve so navedene pod več organskimi sistemi: bolezni krvi in limfatičnega sistema; bolezni živčevja (intrakranialna krvavitev); bolezni dihal, prsnega koša in mediastinalnega prostora (epistaksa); bolezni prebavil (krvavitve iz dlesni, krvavitve iz hemoroidov, krvavitve iz rektuma); bolezni sečil (hematurija); poškodbe, zastrupitve in zapleti pri posegih (kontuzija) in žilne bolezni (ekhimoza).
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8).
Eritropoetska zdravila ali druga zdravila, ki lahko povečajo tveganje za trombozo, kot je hormonsko nadomestno zdravljenje, je treba pri bolnikih z diseminiranim plazmocitomom, ki prejemajo lenalidomid v kombinaciji z deksametazonom, uporabljati previdno (glejte poglavji 4.4 in 4.8).
A higher rate of infections was observed with lenalidomide in combination with dexamethasone than with MPT in patients with NDMM who are not eligible for transplant, and with lenalidomide maintenance compared to placebo in patients with NDMM who had undergone ASCT.
Pogostnejše okužbe so opazili pri lenalidomidu v kombinaciji z deksametazonom kot pri MPT (melfalan, prednizon in talidomid), pri bolnikih z NDMM, ki niso primerni za presaditev, in z vzdrževanjem lenalidomida v primerjavi s placebom pri bolnikih z NDDP, ki so bili podvrženi ASCT.
Viral infections, including herpes zoster and hepatitis B virus reactivation
neznana pogostnost virusne okužbe, vključno z reaktivacijo virusa herpesa zostra in virusa hepatitisa B
The median duration of treatment was 44.0 weeks (min: 0.1, max: 254.9) for len/dex and 23.1 weeks (min: 0.3, max: 238.1) for placebo/dex.
Mediana trajanja zdravljenja je bila v celoti 44,0 tednov (min: 0,1; maks: 254,9) za len/deks in 23,1 tedna (min: 0,3 maks: 238,1) za placebo/deks.
Lenalidomide maintenance in patients who have undergone autologous stem cell transplantation (ASCT)
Novo diagnosticirani diseminirani plazmocitom (NDDP) Vzdrževalno zdravljenje z lenalidomidom pri bolnikih, pri katerih je bila opravljena avtologna presaditev matičnih celic (ASCT - autologous stem cell transplantation)
This increase was not observed in clinical trials of newly diagnosed multiple myeloma in patients taking lenalidomide in combination with low dose dexamethasone compared to thalidomide in combination with melphalan and prednisone.
Tega zvečanja niso opazili v kliničnih preskušanjih novo diagnosticiranega diseminiranega plazmocitoma pri bolnikih, ki so jemali lenalidomid v kombinaciji z deksametazonom v majhnem odmerku, v primerjavi s talidomidom v kombinaciji z melfalanom in prednizonom.
• Numbness, tingling or burning sensation to the skin, pains in hands or feet, dizziness, tremor,
• otrplost, mravljinčenje ali pekoč občutek na koži, bolečine v dlaneh ali stopalih, omotica,
The recommended dose of dexamethasone is 40 mg orally once daily on days 1, 8, 15 and 22 of repeated 28-day cycles.
Priporočeni odmerek deksametazona je 40 mg peroralno enkrat na dan 1., 8., 15. in 22. dan, v ponavljajočih se 28-dnevnih ciklih.
In clinical trials in previously treated myeloma patients with lenalidomide/dexamethasone compared to controls, mainly comprising of basal cell or squamous cell skin cancers.
*V kliničnih preskušanjih bolnikov s plazmocitomom, predhodno zdravljenih z lenalidomidom/deksametazonom, v primerjavi s kontrolnimi skupinami, ki so jih pretežno sestavljali bazalnocelični ali ploščatocelični karcinom kože.
Therefore breast-feeding should be discontinued during therapy with lenalidomide.
Zato je treba med zdravljenjem z lenalidomidom dojenje prekiniti.
• That if his partner becomes pregnant whilst he is taking Lenalidomide Accord or shortly after he has stopped taking Lenalidomide Accord he should inform his treating doctor immediately
• če partnerica zanosi, medtem ko bolnik jemlje zdravilo Lenalidomide Accord ali kmalu po prenehanju jemanja zdravila Lenalidomide Accord, mora takoj obvestiti zdravnika, ki je zdravilo predpisal;
Ask your pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.Taki ukrepi pomagajo varovati okolje.
• Wheezing, breathlessness or a dry cough, which may be symptoms caused by inflammation of the tissue in the lungs.
• sopenje, zasoplost ali suh kašelj, ki so lahko simptomi vnetja pljučnega tkiva;
Repeated oral administration of 1 and 2 mg/kg/day to monkeys for up to 1 year produced reversible changes in bone marrow cellularity, a slight decrease in myeloid/erythroid cell ratio and thymic atrophy.
Ponavljajoča se 1-letna peroralna uporaba odmerkov 1 in 2 mg/kg/dan pri opicah je povzročila reverzibilne spremembe celularnosti kostnega mozga, rahlo zmanjšanje razmerja mieloičnih in eritroidnih celic ter atrofijo timusa.
• If you do become pregnant during your treatment with lenalidomide , you must stop the treatment and inform your doctor immediately.
• Če med jemanjem lenalidomida zanosite, morate takoj prekiniti zdravljenje in obvestiti zdravnika.
Lenalidomide is structurally related to thalidomide.
Lenalidomid je strukturno soroden talidomidu.
Newly diagnosed multiple myeloma: patients who are not eligible for transplant
Novo diagnosticirani diseminirani plazmocitom: bolniki, ki niso primerni za presaditev
Lenalidomide induced in monkey malformations similar to those described with thalidomide (see section 5.3).
Lenalidomid je pri opicah povzročil deformacije, ki so podobne deformacijam opisanim pri talidomidu (glejte poglavje 5.3).
Ischemia, Peripheral ischemia, Intracranial venous sinus thrombosis
pogosti vaskulitis občasni ishemija, periferna ishemija, intrakranialna venska sinusna tromboza
• Brochure for male patients
• brošure za moške bolnike.
Lenalidomide Accord must be given to you by healthcare professionals with experience in treating multiple myeloma,.
Zdravilo Lenalidomide Accord vam sme dati samo zdravstveni delavec, ki ima izkušnje z zdravljenjem diseminiranega plazmocitoma.
• Disposal of unwanted medicine
• odstranjevanje odvečnega zdravila,
Grade 4 febrile neutropenia episodes were observed infrequently (1.7% in MPR+R/MPR+p treated patients compared to 0.0 % in MPp+p treated patients; see section 4.8).
Epizode febrilne nevtropenije 4. stopnje so opazili redko (1,7 % bolnikov, zdravljenih z MPR+R/MPR+p v primerjavi z 0,0 % bolnikov, zdravljenih z MPp+p; glejte poglavje 4.8).
How to take Lenalidomide Accord 4.
Kako jemati zdravilo Lenalidomide Accord 4.
In both studies, patients in the lenalidomide/dexamethasone (len/dex) group took 25 mg of lenalidomide orally once daily on days 1 to 21 and a matching placebo capsule once daily on days 22 to 28 of each 28-day cycle.
V obeh študijah so bolniki v skupini, ki je prejemala lenalidomid/deksametazon (len/deks), od 1. do 21. dne enkrat na dan jemali 25 mg lenalidomida peroralno ter ustrezno kapsulo s placebom enkrat na dan od 22. do 28. dne v vsakem 28-dnevnem ciklu.
You must not breast-feed when taking lenalidomide , as it is not known if lenalidomide passes into human milk.
Dojenje Ni znano, ali lenalidomid prehaja v materino mleko, zato med jemanjem lenalidomida ne smete dojiti.
Not Known Solid organ transplant rejection
Bolezni imunskega sistema neznana pogostnost zavrnitev presajenega organa
An absence of the intermediate lobe of the lung was observed at 10 and 20 mg/kg/day with dose dependence and displaced kidneys were observed at 20 mg/kg/day.
Pri odmerkih 10 in 20 mg/kg/dan so opazili od odmerka odvisno odsotnost srednjega pljučnega režnja, pri odmerku 20 mg/kg/dan pa premik ledvic.
For patients older than 75 years of age treated with lenalidomide in combination with dexamethasone, the starting dose of dexamethasone is 20 mg once daily on days 1, 8, 15 and 22 of each 28-day treatment cycle.
Pri bolnikih, starejših od 75 let, ki se zdravijo z lenalidomidom v kombinaciji z deksametazonom, je začetni odmerek deksametazona 20 mg enkrat na dan 1., 8., 15. in 22. dan v vsakem 28-dnevnem ciklu zdravljenja.
• Fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection including within the bloodstream (sepsis)
• zvišano telesno temperaturo, mrzlico, boleče grlo, kašelj, razjede v ustih ali katerekoli druge simptome okužbe, vključno v krvnem obtoku (sepsa);
5 mg (days 1-21 every 28 days)
Raven odmerka -2 5 mg (od 1. do 21. dne vsakih 28 dni)
The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the placebo arms in the pivotal multiple myeloma studies (see section 5.1).
Podatki niso bili prilagojeni glede na daljše trajanje zdravljenja v skupinah z lenalidomidom, ki so ga dajali do napredovanja bolezni, v primerjavi s skupinami s placebom v ključnih študijah diseminiranega plazmocitoma (glejte poglavje 5.1).
The recommended starting dose is lenalidomide 10 mg orally once daily on days 1 to 21 of repeated 28-day cycles for up to 9 cycles, melphalan 0.18 mg/kg orally on days 1 to 4 of repeated 28-day cycles, prednisone 2 mg/kg orally on days 1 to 4 of repeated 28-day cycles.
Priporočeni začetni odmerek lenalidomida je 10 mg peroralno enkrat na dan od 1. do 21. dne, v ponavljajočih se 28-dnevnih ciklih, do 9 ciklov; melfalan 0,18 mg/kg peroralno od 1. do 4. dne, v ponavljajočih se 28-dnevnih ciklih, prednizon 2 mg/kg peroralno od 1. do 4. dne, v ponavljajočih se 28-dnevnih ciklih.
The results of PFS at unblinding, following a preplanned interim analysis, using a cut-off of 17 December 2009 (15.5 months follow up) showed a 62% reduction in risk of disease progression or death favoring lenalidomide (HR = 0.38; 95% CI 0.27, 0.54; p <0.001).
Rezultati PFS ob prekinitvi dvojno slepega zdravljenja po vnaprej načrtovani vmesni analizi, z datumom zaključka zbiranja podatkov 17. december 2009 (15,5 meseca sledenja), so pokazali 62 % zmanjšanje tveganja napredovanja bolezni ali smrti v prid lenalidomidu (HR = 0,38; 95 % IZ 0,27; 0,54; p <0,001).
The data were not adjusted according to the longer duration of treatment in the lenalidomide-containing arms continued until disease progression versus the comparator arms in the pivotal multiple myeloma studies (see section 5.1).
Podatki niso bili prilagojeni glede na daljše trajanje zdravljenja v skupinah z lenalidomidom, ki so ga dajali do napredovanja bolezni, v primerjavi s primerjalnimi skupinami v ključnih študijah diseminiranega plazmocitoma (glejte poglavje 5.1).
Supportive newly diagnosed multiple myeloma studies
Podporne študije novo diagnosticiranega diseminiranega plazmocitoma
Tabulated summary for combination therapy in MM
Povzetek za kombinirano zdravljenje DP v obliki preglednice