natgillin/translations-raw huggingface dataset:
Patienter med tidligere behandlet let-kæde AL-amyloidose Der blev udført et åbent, ikke-randomiseret fase I/II-forsøg for at fastlægge bortezomibs sikkerhed og virkning hos patienter, der tidligere var blevet behandlet for AL-amyloidose. 
Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Du må ikke køre bil, eller betjene værktøj eller maskiner, hvis du får sådanne bivirkninger. 
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious.
Klinisk virkning hos tidligere ubehandlede myelomatosepatienter Et prospektivt, internationalt, randomiseret (1:1), åbent klinisk fase III-forsøg (MMY-3002 VISTA) med 682 patienter blev gennemført for at fastlægge, om bortezomib (1,3 mg/m som intravenøs injektion) i kombination med melphalan (9 mg/m 2) og prednison (60 mg/m 2) medførte en forbedring i tid indtil progression (TTP) sammenlignet med melphalan (9 mg/m2) og prednison (60 mg/m2) til patienter med tidligere ubehandlet myelomatose. 
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) 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.
Der er indberettet sjældne tilfælde af akut diffus lungesygdom (infiltration) med ukendt ætiologi, for eksempel pneumonitis, interstitiel pneumoni, lungeinfiltration og ARDS (Acute Respiratory Distress Syndrome) hos patienter i behandling med bortezomib (se pkt. 
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
MCL-patientpopulationen sammenlignet med patienter i myelomatose-forsøgene er en ≥ 5% højere forekomst af hæmatologiske bivirkninger (neutropeni, thrombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme. 
Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anaemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
• Høretab, døvhed eller ringen for ørerne, ubehag i ørerne 
• Hearing loss, deafness or ringing in the ears, ear discomfort
Samlet overlevelse* Hændelser (dødsfald) n (%) Median a 
Overall survival* Events (deaths) n (%) Median a (95% CI)
Aktivt stof: bortezomib. 
The active substance is bortezomib.
I fase III-forsøget havde patienter, der fik bortezomib subkutant sammenlignet med intravenøst indgivet, en 13% lavere samlet forekomst af bivirkninger i forbindelse med behandlingen i form af toksicitet grad 3 og en 5% lavere forekomst af seponering af behandling med bortezomib. 
In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Der er yderligere oplysninger i produktresuméet for rituximab. 
Refer to the Summary of Product Characteristics of rituximab for more information.
Den samlede forekomst af hepatitis B-infektioner var sammenlignelig hos patienter i BR-CAPgruppen og patienter i R-CHOP-gruppen (henholdsvis 0,8% vs. 1,2%). 
The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
• diaré, forstoppelse, kvalme eller opkastning 
• diarrhoea, constipation, nausea or vomiting
• Leddegigt, herunder betændelse i leddene i fingre, tæer og kæbe 
• Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
Forsøgets primære effektendepunkt var responsraterne efter induktion og efter transplantation (CR+nCR). 
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Den rekonstituerede opløsning skal anvendes umiddelbart efter klargøring. 
The reconstituted solution should be used immediately after preparation.
• Søvnbesvær eller søvnproblemer, svedeture, angst, humørsvingninger, nedtrykthed, 
• Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
på dag 1 og prednison 100 mg/m2 oralt på dag 1 til og med dag 5 i bortezomib-behandlingscyklussens 21 dage. 
and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Thrombocyttallet var lavest på dag 11 i hver cyklus af behandling med bortezomib og var typisk vendt tilbage til baseline-niveau ved den næste cyklus. 
Platelets were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Tabel 9: Forekomsten af perifer neuropati ved induktionsbehandling, inddelt efter toksicitet og behandlingsseponering på grund af perifer neuropati 
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Pegyleret liposomal doxorubicin administreres i en dosis på 30 mg/m² på dag 4 af behandlingscyklussen med Bortezomib Hospira som en 1-times intravenøs infusion, der administreres efter injektionen af Bortezomib Hospira. 
Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the Bortezomib Hospira treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Hospira injection.
Tabel 5: Dosisjusteringer under behandlingen af patienter med tidligere ubehandlet mantle-cellelymfom 
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Toxicity
• Dødsfald 
• Death
Bortezomib vil blive givet af sundhedspersonale, som har erfaring med anvendelse af cytostatika. 
Bortezomib will be administered by a health care professional experienced in the use of cytotoxic medicines.
Der foreligger begrænsede oplysninger om genbehandling med bortezomib af recidiverende myelomatose. 
Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
• Rødmen og smerter på injektionsstedet 
• Redness and pain at injection site
Fra forsøg, hvor bortezomib blev administreret som induktionsbehandling i kombination med dexamethason (forsøg IFM-2005-01) og dexamethason-thalidomid (forsøg MMY-3010), ses forekomsten af perifer neuropati ved kombinationsbehandlingerne i nedenstående tabel: 
In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
I forsøget IFM-2005-01 blev bortezomib i kombination med dexamethason [BDx, n=240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n=242]. 
In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
I generelle toksicitetsforsøg med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave-tarm-kanalen (som gav opkastning og/eller diaré), hæmatopoietiske og lymfatiske væv (som gav perifere blodcytopenier), lymfoid vævsatrofi og hæmatopoietisk knoglemarvs-hypocellularitet, perifer neuropati (set hos aber, mus og hunde) som involverer sensoriske nerveaxoner og mindre forandringer i nyrerne. 
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
Ved de efterfølgende doser var de gennemsnitlige maksimale plasmakoncentrationer, der blev observeret, inden for intervallet 67-106 ng/ml for dosis på 1,0 mg/m2 og 89-120 ng/ml for dosis på 1,3 mg/m2. 
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to
Erythema multiforme, urticaria, akut febril neutrofil dermatose, toksisk huderuption, toksisk epidermal nekrolyse 
Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
De væsentligste effektresultater ses i tabel 12. 
Main efficacy results are presented in Table 12.
Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med Bortezomib Hospira for at kontrollere niveauet af dine blodlegemer. 
You will have to take regular blood tests before and during your treatment with Bortezomib Hospira, to check your blood cell counts regularly.
Bortezomib gives intravenøst eller subkutant på dag 1, 4, 8 og 11, efterfulgt af en pause uden behandling. 
Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Dosisjusteringer under behandling og reinitiering af behandlingen som monoterapi Behandling med Bortezomib Hospira skal afbrydes ved forekomst af enhver ikke-hæmatologisk toksicitet grad 3 eller enhver hæmatologisk toksicitet grad 4, bortset fra neuropati som beskrevet nedenfor (se også pkt. 
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib Hospira treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Dexamethason gives i en dosis på 40 mg gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i den 28dages behandlingscyklus med bortezomib, og thalidomid gives dagligt gennem munden i en dosis på 50 mg frem til dag 14 i den første cyklus, og hvis du kan tåle thalidomiddosen, øges den til 100 mg på dag 15-28 og kan derefter øges igen til 200 mg dagligt fra og med den anden cyklus. 
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Kløe*, dermatitis*, udslæt* 
Pruritus*, Dermatitis*, Rash*
Fra forsøget LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), ses forekomsten af perifer neuropati i kombinationsbehandlingerne i tabellen nedenfor: 
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Hvis Bortezomib Hospira gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler gennemgås, inden behandling med Bortezomib Hospira initieres. 
When Bortezomib Hospira is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Bortezomib Hospira.
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få bortezomib intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison. 
If you have not been treated before for mantle cell lymphoma, you will receive bortezomib intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få bortezomib intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling. 
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Hyperbilirubinæmi*, unormale proteinanalyser*, vægttab, vægtstigning 
Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Det skal du vide, før du begynder at bruge Bortezomib Hospira 
What you need to know before you use Bortezomib Hospira
Bortezomib Hospira rekonstitueret opløsning administreres som en intravenøs bolusinjektion af 3-5 sekunders varighed gennem et perifert eller centralt intravenøst kateter efterfulgt af skylning med natriumchlorid 9 mg/ml (0,9%) injektionsvæske. 
Bortezomib Hospira 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.
Bemærk: Bortezomib Hospira er et cytotoksisk middel. 
Note: Bortezomib Hospira is a cytotoxic agent.
Når Bortezomib Hospira gives i kombination med andre cytostatika, bør passende dosisreduktion af disse præparater desuden overvejes i tilfælde af toksicitet og i overensstemmelse med anbefalingerne i de respektive produktresuméer. 
In addition, when Bortezomib Hospira is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Hos patienter med MCL (forsøg LYM-3002) var der en højere forekomst (56,7% vs. 5,8%) af thrombocytopeni grad ≥ 3 i bortezomib-gruppen (BR-CAP) sammenlignet med non-bortezomibgruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP]). 
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
• Rødmen eller smerter på injektionsstedet 
• Redness or pain at the injection site
5.3 vedrørende prækliniske kardiovaskulære forsøg af sikkerhedsfarmakologien. 
For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Hætteglas på 10 ml (type I-glas) med gummiprop og aluminiumsforsegling, der indeholder 2,5 mg, 3 mg eller 3,5 mg bortezomib. 
Type I glass 10 ml vial with a rubber stopper and an aluminium seal containing 2.5 mg, 3 mg or 3.5 mg bortezomib.
Hos patienter med MCL (forsøg LYM-3002) var forekomsten af herpes zoster-infektion 6,7% i BRCAP-gruppen og 1,2% i R-CHOP-gruppen (se pkt. 
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
I forsøg MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127]. 
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Kun til s.c. eller i.v. 
SC or IV use only.
Bortezomib Hospira er kun beregnet til engangsbrug. 
Bortezomib Hospira is for single use only.
Du skal straks kontakte lægen, hvis du på trods af dette alligevel bliver gravid. 
If, despite these measures, pregnancy occurs, tell your doctor immediately.
En hazard ratio på mindre end 1 indikerer en fordel for VMP Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: β2 -mikroglobulin, albumin og region d. 
A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors
Perifer neuropati omfatter de foretrukne termer: perifer sensorisk neuropati, perifer neuropati, perifer motorisk neuropati og perifer sensomotorisk neuropati 
Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Fertilitet Der er ikke udført fertilitetsforsøg med Bortezomib Hospira (se pkt. 
Fertility Fertility studies were not conducted with Bortezomib Hospira (see section 5.3).
• Afmagring eller tab af kropsmasse 
• Wasting, or loss of body mass
OR for responsrater baseret på Mantel-Haenszel-estimat af den fælles odds ratio for stratificerede tabeller; 
OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p values by Cochran Mantel-Haenszel test.
Der er i kliniske forsøg indberettet hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale antidiabetika. 
During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Til bekræftelse af PRESdiagnosen anvendes billeddiagnostik af hjernen, fortrinsvis magnetisk resonans (MR). 
Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Reaktivering og infektion af hepatitis B-virus (HBV) Mantle-celle-lymfom 
Hepatitis B Virus (HBV) reactivation and infection
1.3 Den rekonstituerede opløsning indeholder ingen konserveringsmidler og skal anvendes umiddelbart efter klargøring. 
1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
HBV-infektion med fatale udfald forekom hos 0,8% (n=2) af patienterne i non-bortezomib-gruppen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; R-CHOP) og hos 0,4% (n=1) af patienterne i gruppen på bortezomib plus rituximab, cyclophosphamid, doxorubicin og prednison (BRCAP). 
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP).
> 1,0 x -1,5 x ULN Vilkårligt 
> 1.0 x -1.5 x ULN Any
Patienterne fik administreret intravenøse doser bortezomib på 0,7-1,3 mg/m 2 2 gange ugentligt. 
Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of bortezomib twice weekly.
Hver pakning med 2,5 mg, 3 mg eller 3,5 mg Bortezomib Hospira indeholder et 10 ml hætteglas med gummiprop og aluminiumsforsegling. 
Each carton of 2.5 mg, 3 mg or 3.5 mg Bortezomib Hospira contains a glass 10 ml vial with a rubber stopper and an aluminium seal.
Bortezomib er en proteasomhæmmer. 
Bortezomib is a proteasome inhibitor.
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få bortezomib intravenøst eller subkutant samtidig med to andre lægemidler melphalan og prednison. 
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with two other medicines; melphalan and prednisone.
• Lidelser forbundet med injektionsstedet eller injektionsudstyret 
• Injection site or injection device related disorders
Afbryd behandling med Bortezomib Hospira, indtil toksicitetssymptomerne er svundet til grad 2 eller bedre. 
Bortezomib Hospira therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
PN ≥ grad 2 
≥ Grade 2 PN
De mest almindelige bivirkninger, der er indberettet under behandling med bortezomib, er kvalme, diarré, obstipation, opkastning, træthed, pyreksi, thrombocytopeni, anæmi, neutropeni, perifer neuropati (herunder sensorisk neuropati), hovedpine, paræstesi, nedsat appetit, dyspnø, udslæt, herpes zoster og myalgi. 
The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Patienterne i BDx-gruppen fik 4 cyklusser af 21-dages varihed, hver bestående af bortezomib (1,3 mg/m administreret intravenøst 
Patients in the BDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m2 administered intravenously twice weekly on days
Dosisjustering ved kombinationsbehandling for patienter med progressiv myelomatose Dosisjustering af Bortezomib Hospira ved kombinationsbehandling skal følge de retningslinjer, der er beskrevet under monoterapi ovenfor. 
Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib Hospira dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
VDDx=vincristin, doxorubicin, dexamethason; BDx=bortezomib, dexamethason; TDx=thalidomid, dexamethason; 
VDDx=vincristine, doxorubicin, dexamethasone; BDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone;
nCR n (%) CR+PR 
f n (%) nCR n (%) CR+PR
Der administreres fire behandlingscyklusser med denne kombination. 
Four treatment cycles of this combination are administered.
* Gruppering af mere end én ”foretrukken term” iht. 
NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
#, dermatitis*, hårsygdom*, petekkier, ekkymose, hudlæsion, purpura, udfyldning i huden*, psoriasis, hyperhidrose, nattesved, decubitus 
#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
• Injicér opløsningen subkutant i en vinkel på 45-90°. 
• Inject the solution subcutaneously, under a 45-90°angle.
• Generel følelse af at være syg, smerter, svimmelhed, ørhed, en følelse af afkræftelse eller bevidsthedstab 
• General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
Klinisk virkning ved recidiverende eller refraktær myelomatose Sikkerheden og effekten ved bortezomib (som intravenøs injektion) blev undersøgt i 2 forsøg med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-forsøg (APEX), vs. dexamethason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-forsøg med en enkelt gruppe med 202 patienter med recidiverende eller refraktær myelomatose, som havde fået mindst 2 tidligere behandlinger, og som i deres seneste behandlingsregime havde oplevet progression. 
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.