natgillin/translations-raw huggingface dataset:
I fase III-studiet med hidtil ubehandlede myelomatosepatienter var den samlede forekomst af herpes zoster-reaktivering større hos patienter behandlet med bortezomib+melphalan+prednison sammenlignet med melphalan+prednison (henholdsvis 14 % versus 4 %). 
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Varigheden af det samlede respons var 21,4 måneder længere i BRCAP-gruppen (median 36,5 måneder kontra 15,1 måneder i R-CHOP-gruppen). 
The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Absorption Efter intravenøs bolusadministration af en dosis på 1,0 mg/m og 1,3 mg/m til 11 patienter med myelomatose og kreatininclearance-værdier på mere end 50 ml/min., var de gennemsnitlige maksimale plasmakoncentrationer efter første dosis af bortezomib henholdsvis 57 og 112 mg/ml. 
Absorption Following intravenous bolus administration of a 1.0 mg/m and 1.3 mg/m dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Bortezomibs farmakokinetik blev karakteriseret efter intravenøs bolus-administration af 1,3 mg/m doser to gange ugentlig til 104 pædiatriske patienter (2-16 år) med akut lymfoblastær leukæmi (ALL) eller akut myeloid leukæmi (AML). 
The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Median for investigatorbedømt PFS var 30,7 måneder i BR-CAP-gruppen og 16,1 måneder i RCHOP-gruppen (Hazard ratio [HR]=0,51; p < 0,001). 
Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
• Infektion i øjets yderste lag og i indersiden af øjenlåget (Konjunktivitis) 
• Infection of the outermost layer of the eye and the inner surface of the eyelids
Notérbare forskelle mellem sikkerhedsprofilen for bortezomib administreret subkutant versus intravenøst som monoterapi 
Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
p-værdi d 
p-value d
Hvis du får bortezomib for myelomatose eller mantle-celle-lymfom, skal du straks kontakte din læge, hvis du oplever nogle af nedenstående bivirkninger: - Muskelkramper, muskelsvaghed - Forvirring, synstab eller -forstyrrelser, blindhed, krampeanfald, hovedpine - Åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - Hoste og vejrtrækningsbesvær eller trykken for brystet. 
If you are given bortezomib for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
forekom hos 6 % af patienterne i den subkutane behandlingsgruppe sammenlignet med 16 % i den intravenøse behandlingsgruppe (p=0,0264). 
Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få bortezomib 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 together with two other medicines; melphalan and prednisone.
Forekomsten af herpes zoster blandt patienter i BR-CAP-armen var 10,7 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3,6 % hos patienter, der havde fået antiviral profylakse (se pkt. 
The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Responserate Populatione n=668 
Response rate population e n=668
1 mg/m til 0,7 mg/m 
1 mg/m to 0.7 mg/m
In vitro-studier viser, at bortezomib er en svag inhibitor af CYP-isozymerne 1A2, 2C9, 2C19, 2D6 og 3A4. 
In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med bortezomib i alle undergrupper af den pædiatriske population ved myelomatose og ved mantlecellelymfom (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Bortezomib kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn. 
Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
I alt fik 74 vurderbare patienter administreret dexamethason sammen med bortezomib. 
A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Dosisjustering under behandlingen af patienter med tidligere ubehandlet mantlecellelymfom Før påbegyndelse af en ny behandlingscyklus: 
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Bortezomib må ikke indgives via andre administrationsveje. 
Bortezomib should not be given by other routes.
I fase III-studiet havde patienter, der fik bortezomib subkutant sammenlignet med intravenøs administration, en 13 % lavere samlet forekomst af bivirkninger der havde en grad 3 eller højere toksicitet, 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.
Hvis der ses nogle partikler eller misfarvning, skal opløsningen bortskaffes. 
If any discolouration or particulate matter is observed, the solution must be discarded.
CR=komplet respons; CRu=komplet respons ubekræftet; PR=partielt respons; CI=konfidensinterval, HR=hazard-ratio; OR=oddsratio; ITT= Intent to Treat 
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Bemærk: OR > 1 tyder på en fordel for B-indeholdende induktionsterapi. 
Note: An OR > 1 indicates an advantage for B-containing induction therapy.
Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med bortezomib, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med bortezomib. 
You must read the package leaflets of all medicinal products to be taken in combination with bortezomib for information related to these medicines before starting treatment with bortezomib.
For bortezomib-relateret neuropatisk smerte og/eller perifer neuropati, tilbageholdes og/eller modificeres bortezomib som beskrevet i tabel 1. 
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify bortezomib as outlined in table 1.
198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx- og BDx-gruppen fik autolog stamcelletransplantation. 
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx groups respectively; the majority of patients underwent one single transplant procedure.
Behandlingen med bortezomib skal indstilles, når trombocyttallet er < 25.000/µl eller, ved kombinationsbehandling med melphalan og prednison, når trombocyttallet er ≤ 30.000/µl (se pkt. 
Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/μl (see section 4.2).
(SGOT) ASATniveau 
SGOT (AST) levels
Almindelig Vægttab Ikke almindelig Hyperbilirubinæmi*, abnorme proteinanalyser*, vægtstigning, abnorm blodprøve*, forhøjet C-reaktivt protein 
Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
c p-værdi d 
c p-value d
Studier af udviklingstoksicitet på rotter og kaniner har vist embryo/fosterdødelighed ved doser som var toksiske for moderdyret, men ingen direkte embryo/fostertoksicitet ved doser som ikke var toksiske for moderdyret. 
Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Bortezomib skal rekonstitueres af sundhedspersonale (se pkt. 
Bortezomib must be reconstituted by a healthcare professional (see section 6.6).
Særligt skal du fortælle lægen, hvis du bruger medicin, som indeholder følgende aktive stoffer: 
You must tell your doctor if you have any of the following:
Graden er bestemt i henhold til det amerikanske National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0. 
Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
B= bortezomib; Dx=dexamethason; T=thalidomid a Thalidomid-dosis øges kun til 100 mg fra uge 3 i cyklus 1, hvis 50 mg tåles, og til 200 mg fra og med cyklus 2, hvis 100 mg tåles. 
B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
• Betændelse i en vene, blodpropper i dine vener eller lunger 
• Inflammation of a vein, blood clots in your veins and lungs
Behandling med bortezomib skal seponeres ved forekomst af enhver ≥ grad 3 bortezomib-relateret ikke-hæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt. 
Bortezomib treatment must be withheld at the onset of any ≥ grade 3 bortezomib -related non-haematological toxicities (excluding neuropathy) or ≥ grade 3 haematological toxicities (see also section 4.4).
Patienter med ≥ grad 2 perifer neuropati eller trombocyttal < 50.000/µl ved baseline indgik ikke. 
Patients with baseline grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
(95% CI) p-værdi c 
(95% CI) p-value c
Responsrate ved 8 cyklusser n (%) ORR (CR+PR) p-value a 
Response Rate at 8 cycles n (%) ORR (CR+PR) p-value a
- Øvrigt indholdsstof: Mannitol (E421) 
- The other ingredients are mannitol (E421).
Behandling med bortezomib skal indstilles indtil symptomerne på toksiciteten er bedret til Grad 2 eller bedre. 
Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 2 or better.
Ved efterfølgende doser lå de gennemsnitlige maksimale observerede plasmakoncentrationer på 67-106 ng/ml for en dosis på 1,0 mg/m og på 89-120 ng/ml for en dosis på 1,3 mg/m 
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m dose and 89 to 120 ng/ml for the 1.3 mg/m dose.
Patienter, der får bortezomib i kombination med thalidomid, skal overholde det særlige program for svangerskabsforebyggelse for thalidomid. 
Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Under kliniske studier er der rapporteret om hypoglykæmi og hyperglykæmi som henholdsvis ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika. 
During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Patientdemografi og sygdomsegenskaber ved baseline var sammenlignelige mellem behandlingsgrupperne. 
Patient demographic and baseline disease charateristics were similar between the treatment groups.
• Oplysning om potentielle risici ved administration - herunder overdosering og underdosering, 
• storage precautions for reconstituted solution • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Virkningsmekanisme> 
Mechanism of action
Thalidomid administreres oralt i en dosis på 50 mg daglig på dag 1-14, og hvis det tåles, øges dosis til 100 mg daglig på dag 15-28, hvorefter dosis yderligere kan øges til 200 mg daglig fra cyklus 2 (se tabel 4). 
Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see table 4).
Ved sammenligning med patienter med normal leverfunktion ændrede en let nedsættelse af leverfunktionen ikke bortezomibs AUC normaliseret i forhold til standarddosis. 
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
10 ml klart type I-hætteglas med grå chlorbutyl gummiprop og blå aluminiumshætte med flip-off indeholdende 3,5 mg bortezomib. 
10 ml clear Type I glass vial with grey chlorobutyl rubber stopper and blue aluminium flip-off over seal, containing 3.5 mg bortezomib.
Både BR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i BR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen. 
Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Tabel 1: Anbefalede* dosisjusteringer for bortezomibrelateret neuropati Sværhedsgrad af neuropati 
Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Den normale startdosis af bortezomib er 1,3 mg/m legemsoverflade to gange om ugen. 
The usual starting dose of bortezomib is 1.3 mg/m body surface area twice a week.
Bemærk: OR > 1 tyder på en fordel for bortzomib-indeholdende induktionsterapi 
Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy
Tabel 16: Effektresultater fra studie LYM-3002 Effektmål 
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Den samlede opbevaringstid for det rekonstituerede lægemiddel må ikke overstige 96 timer (hvis opbevaret ved 25⁰C) og 8 dage (hvis opbevaret ved 2-8⁰C) inden administration. 
The total storage time for the reconstituted medicinal product should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8 °C) prior to administration.
I fase III-studiet, hvor bortezomib administreret intravenøst versus subkutant blev sammenlignet, var forekomsten af hændelser med ≥ grad 2 perifer neuropati 24 % i gruppen, der fik subkutane injektioner, og 41 % i gruppen der fik intravenøse injektioner (p=0,0124). 
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Ved anvendelse af thalidomid er det nødvendigt at være særligt opmærksom på behovet for graviditetstests og prævention (se pkt. 
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f.eks. serumsygetypereaktioner, polyarthritis med udslæt og proliferativ glomerulonefritis. 
Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Det primære effektmål for studiet var post-induktions- og post-transplantations-responsrater (CR+nCR). 
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Når symptomerne er forsvundet, genstartes behandling med bortezomib og reducér dosis til 0,7 mg/m én gang om ugen. 
When toxicity resolves re-initiate bortezomib treatment and reduce dose to 0.7 mg/m once per week
Almindelig Urinvejsinfektion* 
Urinary tract infection*
Bortezomib-kombinationsbehandling med dexamethason Der blev, på grund af mangel på en direkte sammenligning af bortezomib og bortezomib i kombination med dexamethason hos patienter med progressiv myelomatose, gennemført en statistisk matched-pair-analyse for at sammenligne resultaterne fra den ikke-randomiserede arm med bortezomib i kombination med dexamethason (open-label fase II-studie MMY-2045) med resultaterne fra bortezomib-monoterapiarmene fra forskellige randomiserede fase III-studier (M34101-039 [APEX] og DOXIL MMY-3001) med samme indikation. 
Bortezomib combination treatment with dexamethasone In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Neutrofiltallet var lavest på dag 11 i hver cyklus af bortezomib-behandlingen og var typisk vendt tilbage til baseline-niveau ved næste cyklus. 
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
• Infektioner, herunder urinvejsinfektioner, influenza, herpes virusinfektioner, øreinfektion og cellulitis 
• Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Almindelig Vertigo* 
Vertigo*
Tabel 7: Bivirkninger hos patienter med myelomatose behandlet med bortezomib i kliniske studier samt alle bivirkninger fremkommet efter markedsføring, uanset indikation Systemorganklasse 
Table 7: Adverse reactions in patients with multiple myeloma treated with bortezomib in clinical trials and all post-marketing adverse reactions regardless of indication
I generelle toksicitetsstudier med flere cyklusser med rotter og aber omfattede de vigtigste målorganer mave-tarm-kanalen, hvilket resulterede i opkastning og/eller diarré; hæmatopoietisk og lymfatisk væv, hvilket resulterede i perifere blodcytopenier; lymfoidt vævsatrofi og hæmatopoietisk hypocellularitet i knoglemarven; 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.
Hos patienter med fremskreden myelom var sværhedsgraden af trombocytopeni relateret til trombocyttallet før behandlingen: for trombocyttal ved baseline < 75.000/µl havde 90 % af 21 patienter et tal på ≤ 25.000/µl under studiet, herunder 14 % < 10.000/µl. 
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% < 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
Daglig 
Daily
Studiets primære effektmål var post-induktions-responsrate (CR+nCR). 
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Seponér behandling med bortezomib, indtil symptomer på toksicitet er forsvundet. 
Withhold bortezomib treatment until symptoms of toxicity have resolved.
Der blev observeret en statistisk signifikant forskel i CR+nCR til fordel for gruppen med bortezomib i kombination med dexamethason. 
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i BR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik yderligere 2 cyklusser. 
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Analysen påviste forbedret ORR (CR+PR) (odds-ratio 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (hazard ratio 0,511; 95 % CI 0,309-0,845; p=0,008), 
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Samlet overlevelse* Hændelser (dødsfald) n (%) Median a 
Overall survival* Events (deaths) n (%) Median a
Subkutan anvendelse: Tilsæt 1,4 ml natriumchlorid 0,9%, så den endelige koncentration bliver 2,5 mg/ml. 
Subcutaneous use: Add 1.4 ml sodium chloride 0.9% to make 2.5 mg/ml final concentration.
• Hvis toksiciteten forsvinder dvs. patienten har en ANC ≥ 750 celler/μl og et trombocyttal ≥ 25.000 celler/μl, kan bortezomib re-initieres ved en dosis, som er reduceret 1 dosisniveau (fra 1,3 mg/m til 1 mg/m 2, eller fra 1 mg/m til 0,7 
- If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, bortezomib may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m to 1 mg/m 2, or from
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.
Bortezomib Fresenius Kabi 3,5 mg rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side). 
Bortezomib Fresenius Kabi 3.5 mg reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Det gennemsnitlige distributionsvolumen (Vd) for bortezomib var 1.659-3.294 l efter indgift af enkeltdoser eller gentagne intravenøse doser på 1,0 mg/m eller 1,3 mg/m til patienter med myelomatose. 
The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following singleor repeated-dose intravenous administration of 1.0 mg/m or 1.3 mg/m to patients with multiple myeloma.
Patienter tidligere behandlet for let kæde (AL) amyloidose Der blev udført et open-label, ikke-randomiseret fase I/II-studie for at bestemme bortezomibs sikkerhed og effekt 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.
I studie 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].
Almindelig Hypersensitivitet* Ikke almindelig Anafylaktisk reaktion 
Hypersensitivity* Uncommon Anaphylactic reaction