natgillin/translations-raw huggingface dataset:
Dose adjustments for combination therapy Dose modification and re-initiation of therapy when VELCADE is administered in combination with melphalan and prednisone
Prilagajanje odmerkov in ponovna uvedba zdravljenja pri dajanju zdravila VELCADE v kombinaciji z melfalanom in prednizolonom.
Prior to initiating a new cycle of therapy: • Platelet counts should be ≥ 70 x 109/ l and the absolute neutrophils count should be ≥ 1.0 x 109/ l • Non-haematological toxicities should have resolved to Grade 1 or baseline
Pred začetkom novega kroga zdravljenja: • Število trombocitov mora biti ≥ 70 x 109/ l in celokupno število nevtrofilcev (ANC- Absolute Neutrophil Count) mora biti ≥ 1, 0 x 109/ l. • Ne- hematološki neželeni učinki se morajo vrniti na 1. stopnjo ali vrednost pred začetkom zdravljenja.
Table3: Posology modifications during subsequent cycles Toxicity Haematological toxicity during a cycle
Prilagajanje odmerkov med kasnejšimi krogi zdravljenja Neželen učinek
24 Method of administration The reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ ml (0.9%) solution for injection.
Pripravljeno raztopino dajte naenkrat v obliki 3- 5 sekund trajajoče v bolusne intravenske injekcije preko perifernega ali osrednjega intravenskega katetra, čemur naj sledi izpiranje katetra z 9 mg/ ml (0, 9%) raztopino natrijevega klorida za injiciranje.
Cases of ileus have been uncommonly reported (see section 4.8), therefore patients who experience constipation should be closely monitored.
Občasno so poročali so o primerih zapore črevesja, zato je treba bolnike z zaprtjem skrbno spremljati.
Improvement in, or resolution of, peripheral neuropathy was reported in 51% of patients with ≥ Grade 2 peripheral neuropathy in the single-agent Phase III multiple myeloma study and 71% of patients with grade 3 or 4 peripheral neuropathy or peripheral neuropathy leading to discontinuation of treatment in Phase II studies, respectively.
O izboljšanju ali popolni odpravi periferne nevropatije so poročali pri 51% bolnikov s periferno nevropatijo ≥ 2. stopnje v študiji zdravljenja diseminiranega plazmocitoma, v kateri so v vsakem kraku uporabljali samo eno učinkovino, tretje faze in pri 71% bolnikov v preskušanjih druge faze s periferno nevropatijo 3. ali 4. stopnje ali periferno nevropatijo, ki je vodila do ukinitve zdravljenja.
In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
25 Poleg periferne nevropatije lahko avtonomna nevropatija prispeva k nastanku nekaterih neželenih učinkov npr. posturalne hipotenzije in hudega zaprtja z ileusom.
25 Seizures Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Epileptični napadi Pri bolnikih, ki pred zdravljenjem niso imeli epileptičnih napadov ali epilepsije, so občasno poročali o epileptičnih napadih.
In a single-agent Phase III randomised, comparative study the incidence of heart failure in the VELCADE group was similar to that in the dexamethasone group.
V randomizirani primerjalni študiji tretje faze, v kateri so v vsakem kraku uporabljali samo eno učinkovino, je bila incidenca srčnega popuščanja v skupini, ki je prejemala zdravilo VELCADE, podobna kot v skupini, ki je prejemala deksametazon.
A pre-treatment chest radiograph is recommended to determine if any additional diagnostic measures are necessary and to serve as a baseline for potential post-treatment pulmonary changes.
Pred zdravljenjem je priporočljivo opraviti rentgensko slikanje prsnega koša za odločitev ali so potrebne dodatne diagnostične meritve in za oceno potencialnih pljučnih sprememb po zdravljenju.
In the event of new or worsening pulmonary symptoms (e. g. cough, dyspnoea), a prompt diagnostic evaluation should be performed and patients treated appropriately.
V primeru pojava novih ali poslabšanja obstoječih pljučnih simptomov (npr.: kašelj, dispneja) je potrebna takojšnja diagnostična ocena in uvedba ustreznega zdravljenja bolnika.
The benefit/ risk ratio should be considered prior to continuing VELCADE therapy.
Pred nadaljevanjem zdravljenja z zdravilom Velcade je potrebno oceniti razmerje med koristjo in tveganjem.
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/ m2 per day) by continuous infusion over 24 hours with daunorubicin and VELCADE for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
V kliničnem preskušanju, sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/ m2 na dan) skupaj z daunorubicinom in zdravilom VELCADE umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2g/ m2 per day) by continuous infusion over 24 hours is not recommended.
Zato ta režim dajanja s sočasnim visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/ m2 na dan) ni priporočljiv.
Renal impairment Renal complications are frequent in patients with multiple myeloma.
26 Moteno delovanje ledvic Pri bolnikih z diseminiranim plazmocitomom so pogosti ledvični zapleti.
Such patients should be monitored closely.
Zato jih morate skrbno spremljati (glejte poglavje 4. 2 in 5. 2).
26 Rare cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions.
Bolezni jeter Pri bolnikih z obstoječimi resnimi boleznimi, ki so sočasno prejemali več zdravil so poročali o redkih primerih akutne odpovedi jeter.
Patients should be closely monitored when given bortezomib in combination with CYP2C19- inhibitors (e. g. fluoxetine).
Bolnike, ki prejemajo bortezomib v kombinaciji z inhibitorji encima CYP2C19 (npr. fluoksetin) je treba skrbno spremljati.
In the absence of interaction studies investigating the effect of CYP3A4 inducers on the pharmacokinetics of bortezomib, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inducers (e. g. rifampicin).
27 Zaradi pomanjkanja študiji medsebojnega delovanja, ki bi ocenjevale vpliv induktorjev encima CYP3A4 na farmakokinetiko bortezomiba, je potrebno bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr. rifampicin) skrbno spremljati.
During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Med kliničnimi preskušanji so pri bolnikih z diabetesom, ki prejemajo peroralne antidiabetike, občasno poročali hipoglikemiji in pogosto o hiperglikemiji.
Animal studies to determine the effects of bortezomib parturition and post-natal development were not conducted (see section 5.3).
Študije na živalih za ugotavljanje učinkov bortezomiba na porod in postnatalni razvoj niso bile opravljene (glejte poglavje 5. 3).
The following undesirable effects were considered by the investigators to have at least a possible or probable causal relationship to VELCADE during the conduct of 5 non-comparative Phase II studies and 1 comparative Phase III trial VELCADE vs dexamethasone in 663 patients with relapsed or refractory multiple myeloma, of whom 331 received VELCADE as single agent.
Za spodaj navedene neželene učinke so raziskovalci med izvajanjem petih neprimerjalnih preskušanj druge faze in enega primerjalnega preskušanja tretje faze zdravila VELCADE v primerjavi z deksametazonom pri 663 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, od katerih je 331 prejemalo zdravilo VELCADE v monoterapiji, menili, da imajo vsaj možno ali verjetno vzročno povezavo z zdravilom VELCADE.
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), not known (cannot be estimated from the available data).
Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100, do < 1/ 10); občasni (≥ 1/ 1. 000, do < 1/ 100); redki (≥ 1/ 10. 000, do < 1/ 1. 000); zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov), vključno s posameznimi prijavami.
Table 4:
28 Preglednica 4:
Adverse reactions in patients with relapsed/ refractory multiple myeloma Infections and infestations Very common: herpes zoster (including disseminated).
Občasni:
Uncommon: sepsis, bacteraemia, pneumonia pneumococcal, bronchopneumonia, upper and lower respiratory tract infection, catheter related infection, pleural infection, haemophilus infection, cytomegalovirus infection, influenza, infectious mononucleosis, varicella, urinary tract infection, gastroenteritis, candidal infection, fungal infection, post herpetic neuralgia, oral candidiasis, blepharitis, infection.
Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) Občasni:
Neoplasms benign and malignant (including cysts and polyps) Uncommon: tumour lysis syndrome (see section 4.4).
sindrom razpada tumorja (glejte poglavje 4. 4).
28 Blood and lymphatic system disorders (see section 4.4) Very common:
Občasni:
thrombocytopenia, neutropenia, anaemia.
levkopenija, limfopenija. pancitopenija, febrilna nevtropenija, hemolitična anemija, trombocitopenična purpura,
Common: leukopenia, lymphopenia.
Bolezni imunskega sistema Občasni:
Uncommon: pancytopenia, febrile neutropenia, haemolytic anaemia, thrombocytopenic purpura, lymphadenopathy.
preobčutljivost, z imunokompleksi povzročena preobčutljivost, reakcije, ki so lahko
Immune system disorders Uncommon: hypersensitivity, immunocomplex mediated hypersensitivity, potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis (see section 4.4).
povzročene z imunokopleksi, kot so serumska bolezen, poliartritis z izpuščajem, in proliferativni glomerulonefritis (glejte poglavje 4. 4).
Nervous system disorders(see sections 4.4 and 4.7) Very common:
Pogosti:
Uncommon: paraplegia, intracranial haemorrhage, subarachnoid haemorrhage convulsions (see section 4.4), peripheral motor neuropathy, syncope, paresis, disturbance in attention, increased activity, ageusia, somnolence, migraine, cognitive disorder, jerky movements, dizziness postural, sciatica, mononeuropathy, speech disorder, restless leg syndrome.
periferna motorična nevropatija, sinkopa, pareza, motnje pozornosti, povečana aktivnost, agevsija, zaspanost, migrena, spoznavne motnje, sunkoviti gibi, motnje ravnotežja, išias, mononevropatija, motnje govora, sindrom nemirnih nog.
Eye disorders Common: vision blurred (see section 4.7), eye pain.
Občasni:
Uncommon: eye haemorrhage, vision abnormal, dry eye, conjunctivitis, eye discharge, photophobia, eye irritation, lacrimation increased, conjunctival hyperaemia, eye swelling.
zameglen vid (glejte poglavje 4. 7), bolečina v očesu. krvavitve v očesu, nenormalen vid, suho oko, konjunktivitis, izcedek iz očesa,
Uncommon: deafness, tinnitus, hypoacusis, hearing impaired.
fotofobija, draženje očesa, povečano solzenje, hiperemija veznice, zatekanje očesa.
Rare: new onset of decreased left ventricular ejection fraction.
Občasni:
Vascular disorders Common: hypotension, orthostatic and postural hypotension (see sections 4.4 and 4.7), phlebitis, haematoma, hypertension.
vrtoglavica. gluhost, tinitus, naglušnost, motnje sluha.
29 Respiratory, thoracic and mediastinal disorders Very Common:
29 Srčne bolezni Občasni:
Common: dyspnoea exertional, epistaxis, cough, rhinorrhoea.
možganska krvavitev, vaskulitis, cerebrovaskularni dogodki, pljučna hipertenzija,
Uncommon: respiratory arrest, hypoxia, pulmonary congestion, pleural effusion, asthma, respiratory alkalosis, tachypnoea, wheezing, nasal congestion, hoarseness, rhinitis, hyperventilation, orthopnoea, chest wall pain, sinus pain, throat tightness, productive cough.
alkaloza, tahipneja, piskanje v pljučih, nosna kongestija, hripavost, rinitis, hiperventilacija, ortopneja, bolečina v prsni steni, boleči sinusi, zoženje zgornjih dihalnih poti, produktiven kašelj.
Gastrointestinal disorders (see section 4.4) Very common:
Pogosti:
vomiting, diarrhoea, nausea, constipation.
bolečina v trebuhu, stomatitis, dispepsija, mehko blato, bolečina v zgornjem delu
Common: abdominal pain, stomatitis, dyspepsia, loose stools, abdominal pain upper, flatulence, abdominal distension, hiccups, mouth ulceration, pharyngolaryngeal pain, dry mouth.
Občasni:
rash.
Občasni:
Common: periorbital oedema, urticaria, rash pruritic, pruritus, erythema, sweating increased, dry skin, eczema.
vaskulitični izpuščaj, eritematozni izpuščaj, fotosenzitivna reakcija, kontuzije,
Uncommon: vasculitic rash, rash erythematous, photosensitivity reaction, contusion, pruritus generalised, rash macular, rash papular, psoriasis, rash generalized, eyelid oedema, face oedema, dermatitis, alopecia, nail disorder, skin discolouration, dermatitis atopic, hair texture abnormal, heat rash, night sweats, pressure sore, ichthyosis, skin nodule.
generalizirani pruritus, makularni izpuščaj, papularni izpuščaj, luskavica, generalizirani izpuščaj, edem veke, edem obraza, dermatitis, alopecija, bolezni nohtov, sprememba barve kože, atopični dermatitis, nenormalna struktura las, vročinski izpuščaj, nočno znojenje, preležanine, ihtioza, vozlički v koži.
Musculoskeletal and, connective tissue bone disorders Very Common:
Pogosti:
Uncommon: muscle spasms, muscle twitching or sensation of heaviness, muscle stiffness, joint swelling, joint stiffness, buttock pain, swelling, pain in jaw.
okorelost sklepov, bolečina v zadnjici, otekline, bolečina v čeljusti.
Renal and urinary disorders Common: renal impairment, dysuria.
Občasni:
Uncommon: renal failure acute, renal failure, oliguria, renal colic, haematuria, proteinuria, urinary retention, urinary frequency, difficulty in micturition, loin pain, urinary incontinence, micturition urgency.
ledvična okvara, disurija. akutna ledvična odpoved, ledvična odpoved, oligurija, ledvična kolika, hematurija,
Reproductive system and breast disorders Uncommon: testicular pain, erectile dysfunction.
proteinurija, retencija urina, pogosto uriniranje, težave pri uriniranju, bolečina v ledvenem delu, inkontinenca urina, občutek nujnosti praznenja mehurja.
General disorders and administration site conditions Very Common:
Motnje reprodukcije in dojk Občasni:
fatigue (see section 4.7), pyrexia.
bolečina v modih, erektilna disfunkcija.
Common: asthenia, weakness, lethargy, rigors, malaise, influenza like illness, oedema peripheral, chest pain, pain, oedema.
astenija, letargija, šibkost, otrplost, oslabelost, gripi podobna bolezen, periferni edemi,
Uncommon: fall, mucosal haemorrhage, mucosal inflammation, neuralgia, injection site phlebitis, extravasation inflammation tenderness, injection site erythema, feeling cold, chest pressure sensation, chest discomfort, groin pain, chest tightness.
padec, krvavitev iz sluznice, vnetje sluznice, nevralgija, flebitis na mestu injiciranja,
Investigations Common: weight decreased, blood lactate dehydrogenase increased.
Občasni:
Uncommon: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood alkaline phosphatase increased, blood creatinine increased, blood urea increased, gamma-glutamyltransferase increased, blood amylase increased, liver function tests abnormal, red blood cell count decreased, white blood cell count decreased, blood bicarbonate decreased, heart rate irregular, C-reactive protein increased, blood phosphate decreased, weight increased.
aminotransferaze, povečanje koncentracije bilirubina v krvi, povečanje koncentracije alkalne fosfataze v krvi, povečanje koncentracije kreatinina v krvi, povečanje koncentracije sečnine v krvi, povečanje koncentracije gama glutamiltransferaze, povečanje koncentracije amilaze v krvi, nenormalne vrednosti funkcijskih jetrnih preiskav, zmanjšanje števila eritrocitov, zmanjšanje števila levkocitov, zmanjšanje koncentracije hidrogen karbonata v krvi, neredno bitje srca, povečanje koncentracije C- reaktivnega proteina, zmanjšanje koncentracije fosfatov v krvi, povečanje telesne mase.
Injury and poisoning Uncommon: catheter related complications, post procedural pain, post procedural haemorrhage, burns.
Poškodbe, zastrupitve in zapleti pri posegih Občasni: opekline.
30 Summary of safety data in patients with previously untreated multiple myeloma:
zapleti, povezani z uporabo katetra, bolečina po posegu, krvavitev po posegu,
Total Toxicity Grade, n
število
(%) Total Toxicity Grade, n (%)
število
Thrombocytopenia Neutropenia Anaemia Leukopenia Lymphopenia Metabolism and nutrition disorders
trombocitopenija nevtropenija
164 (48) 60 (18) 160 (47) 101 (30) 33 109 (32) 41 (12) 108 (32) 64 (19) 78 (23) 46 (14)
109 (32) 108 (32)
57 (17) 140 (42) 48 (14) (10) 143 (42) 77 (23) 4 (1) 156 (46) 61 (18) 8 (2) 93 (28) 53 (16) 17 (5) 51 (15) 26 (8)
156 (46) 93 (28)
39 (12) 42 (12) 18 (5) 11 (3) 7 (2)
18 11
35 (10) 1 (< 1)
1 (< 1)
Peripheral Neuropathy Neuralgia Paraesthesia Gastrointestinal disorders
periferna nevropatija nevralgija
156 (46) 42 (12) 117 (34) 27 (8) 42 (12) 6 (2)
156 (46) 117 (34)
2 (1) 4 (1) 0 2 (1) 1 (< 1) 0 0 4 (1) 0
2 (1) 2 (1)
0 0 0
31
Nausea Diarrhoea Vomiting Constipation Abdominal Pain Upper Skin and subcutaneous tissue disorders
-------------- Vc+M+P -------------- (n=340)
134 (39) 10 (3) 119 (35) 19 (6) 87 (26) 13 (4) 77 (23) 2 (1) 34 (10) 1 (< 1)
---------------- M+P --------------- (n=337)
0 70 (21) 1 (< 1) 2 (1) 20 (6) 1 (< 1) 0 41 (12) 2 (1) 0 14 (4) 0 0 20 (6) 0
celokupno stopnja toksičnosti, n (%) celokupno stopnja toksičnosti, n (%) Organski sistemi po MedDRA
0 0 0 0 0
n (%) 3
Rash General disorders and administration site conditions
parestezija Bolezni prebavil
0 7 (2) 0
0 2 (1)
Fatigue Asthenia Pyrexia
70 (21) 20 (6)
85 (25) 19 (6) 54 (16) 18 (5) 53 (16) 4 (1)
1 (< 1) 1 (< 1)
2 (1) 48 (14) 4 (1) 0 23 (7) 3 (1) 0 19 (6) 1 (< 1)
87 (26) 77 (23) 34 (10)
0 0 1 (< 1)
13 (4) 2 (1) 1 (< 1)
Herpes zoster virus reactivation
41 (12) 14 (4) 20 (6)
Three (3%)
2 (1) 0 0
31 of the 91 patients in the Vc+M+P treatment group who received prophylactic anti-virals developed herpes zoster reactivation.
izpuščaj Splošne težave in spremembe na mestu aplikacije
Post Marketing Experience
utrujenost astenija
Their frequency is not known.
85 (25) 54 (16)
Table 6:
19 (6) 18 (5)
Adverse reactions from post-marketing reports Infections and infestations Not known:
(1) 0
Herpes meningoencephalitis, septic shock
48 (14) 23 (7)
Not known:
4 (1) 3 (1)
Nervous system disorders
zvišana telesna temperatura
Angioedema
53 (16)
Not known:
4 (1)
Eye disorders
19 (6)
Encephalopathy, autonomic neuropathy
1 (< 1)
Not known:
1 (< 1)
Ophthalmic herpes
Reaktivacija virusa herpes zoster
Cardiac tamponade, pericarditis, cardiac and cardiopulmonary arrest, Not known:
Med 91 bolniki, v skupini zdravljeni z Vc+M+P, ki so preventivno prejeli protivirusna zdravila je pri treh (3%) prišlo do reaktivacije virusa herpes zoster.
ventricular arrhythmias, atrio-ventricular block complete, atrial fibrillation, tachycardia, sinus and ventricular tachycardia
Njihova pogostnost ni znana.
Respiratory, thoracic and mediastinal disorders (see section 4.4) Pneumonitis, pneumonia, interstitial pneumonia, Acute Respiratory Distress Syndrome (ARDS), acute diffuse infiltrative pulmonary Not known:
Neželeni učinki o katerih so poročali po pridobitvi dovoljenja za promet Infekcijske in parazitske bolezni herpetični meningoencefalitis, septični šok neznana:
Gastrointestinal disorders
Bolezni imunskega sistema angioedem neznana:
disease, pulmonary hypertension, respiratory failure, pulmonary alveolar haemorrhage, acute pulmonary oedema, pulmonary oedema, pulmonary embolism, peripheral embolism
Srčne bolezni tamponada srca, perikarditis, kardialna in kardiorestpiratorna odpoved, ventrikularne aritmije, popolni atrioventrikularni blok, neznana: atrijska fibrilacija, tahikardija, sinusna in ventrikularna tahikardija Bolezni dihal, prsnega koša in mediastinalnega prostora (glejte poglavje 4. 4) pnevmonitis, pljučnica, intersticijska pljučnica, sindrom akutne respiratorne stiske (SARS), akutna difuzna infiltracijska pljučna bolezen, pulmonarna hipertenzija, odpoved dihanja, pljučna neznana: alveolarna hemoragija, akutni pljučni edem, pljučni edem, pljučna embolija, periferna embolija.
Not known:
32 Bolezni prebavil ishemični kolitis neznana:
Not known:
Pri bolnikih je bilo preveliko odmerjanje (odmerki so bili več kot dvakrat višji od priporočenega) povezano z akutnim pojavom simptomatične hipotenzije in trombocitopenije s smrtnimi izidi (glejte poglavje 5. 3 preklinična farmakološka preskušanja kardiovaskularne varnosti zdravila).
Liver failure
Za bortezomibspecifični antidot ni poznan.
In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
V primeru prevelikega odmerjanja zdravila Velcade je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ ali inotropne učinkovine) in telesne temperature (glejte poglavji 4. 2 in 4. 4)
For preclinical cardiovascular safety pharmacology studies, see section 5.3.
FARMAKOLOŠKE LASTNOSTI
There is no known specific antidote for bortezomib overdose.
5. 1 Farmakodinamične lastnosti
Other antineoplastic agent, ATC code:
Farmakoterapevtska skupina: druga zdravila z delovanjem na novotvorbe Oznaka ATC:
At 10 μ M concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1500-fold more selective for the proteasome than for its next preferable enzyme.
Pri koncentraciji 10 μM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz in je več kot 1500krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the proapoptotic effects of proteasome inhibition than normal cells.
Bortezomib je
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
33 povzročil zmanjšanje rasti tumorja in vivo v mnogih predkliničnih tumorskih modelih, vključno z modelom diseminiranega plazmocitoma.
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomized (1:1), open-label clinical study (VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/ m2) in combination with melphalan (9 mg/ m2) and prednisone (60 mg/ m2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/ m2) and prednisone (60 mg/ m2) in patients with previously untreated multiple myeloma.
Klinična učinkovitost pri bolnikih s predhodno ne- zdravljenim diseminiranim plazmocitomom Za ugotovitev ali uporaba zdravila VELCADE (1, 3 mg/ m2) v kombinaciji z melfalanom (9 mg/ m2) in prednizolonom (60 mg/ m2) prispeva k podaljšanju časa do napredovanja bolezni (Time To Progression- TTP) v primerjavi z zdravljenjem samo z melfalanom (9 mg/ m2) in prednizolonom (60 mg/ m2), pri bolnikih s predhodno ne- zdravljenim diseminiranim plazmocitomom, so izvedli prospektivno, mednarodno, randomizirano (1: 1) odprto klinično študijo III. faze (VISTA) pri 682 bolnikih.
Patient Characteristics
Podatki o bolnikih
Caucasian/ asian/ black/ other Karnofsky performance status score ≤ 70 Hemoglobin < 100 g/ l Platelet count < 75 x 109/ l
rasa: belci/ azijci/ temnopolti/ ostalo ocena stanja zmogljivosti po Karnofskem ≤ 70 hemoglobin < 100 g/ l
/ 10% / 1% / 1% 35% 37% < 1%
/ 1% / 1% 35% 37%
87%
< 1%
/ 11% / 2% / 0% 33% 36% 1%
1%
33 Disease Characteristics Type of myeloma (%):
vrsta plazmocitoma (%):
IgG/ IgA/ Light chain Median β 2-microglobulin (mg/ l)
IgG/ IgA/ lahke verige srednja koncentracija β2- mikroglobulina (mg/ l) srednja koncentracija albumina (g/ l)
24% / 8% 4.2
64% / 24% / 8% 4, 2 33, 0
26% / 8% 4.3
26% / 8% 4, 3 33, 0