natgillin/translations-raw huggingface dataset:
Et fase II-forsøg med en enkelt arm vedrørende aktivitet, sikkerhed og farmakokinetik udført af Children's Oncology Group vurderede virkningen af at tilføje bortezomib til reinduktionskemoterapi med flere stoffer hos pædiatriske og unge voksne patienter med lymfoid malignitet (akut præ-B-celle lymfoblastær leukæmi [ALL], T-celle ALL og T-celle lymfoblastært lymfom [LL]). 
A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
• et redskab til beregning af dosis, hvor den ordinerende læge kan indlæse patientens højde og vægt for ud fra disse at beregne arealet af legemsoverfladen og derved fastsætte en passende dosering af Bortezomib SUN. 
• a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate
Indehaver af markedsføringstilladelsen og fremstiller Sun Pharmaceutical Industries Europe B.V. 
Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Studiets primære effektendepunkt var post-induktions-responsrate (CR+nCR). 
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Ved efterfølgende doser lå de gennemsnitlige maksimale observerede plasmakoncentrationer på 67106 ng/ml for en dosis på 1,0 mg/m2 og på 89-120 ng/ml for en 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 120 ng/ml for the 1.3 mg/m2 dose.
Neutrofiltal var lavest på dag 11 i hver cyklus af bortezomib-behandlingen og var typisk vendt tilbage til baseline-niveau ved den næste cyklus. 
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
CR+PRf n (%) p-værdid 
CR+PRf n (%) p-valued
Ud fra et mikrobiologisk synspunkt skal den rekonstituerede opløsning anvendes øjeblikkeligt. 
From a microbiological point of view, the reconstituted solution should be used immediately after preparation.
Den omfatter også bivirkninger fremkommet efter markedsføring, som ikke er set i kliniske studier. 
Post-marketing adverse reactions not seen in clinical trials are also included.
Profylaktisk brug af granulocyt-kolonistimulerende faktorer skal overvejes i tilfælde af gentagne udsættelser af cyklusadministration (se pkt. 
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section 4.2).
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få Bortezomib SUN 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 SUN together with two other medicines; melphalan and prednisone.
Hvis der ses misfarvning eller partikler, skal den rekonstituerede opløsning bortskaffes. 
If any discolouration or particulate matter is observed, the reconstituted solution must be discarded.
Den gennemsnitlige TTP var 6,5 måneder for patienter i monoterapi med bortezomib sammenlignet med 9,3 måneder for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin. 
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Det primære effektendepunkt 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).
Tabel 16: Effektresultater fra studiet LYM-3002 Effektendepunkt 
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Patienter med moderat eller alvorligt nedsat leverfunktion skal starte med en reduceret dosis Bortezomib SUN på 0,7 mg/m2 pr. injektion i den første behandlingscyklus; efterfølgende dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2 kan overvejes, afhængigt af patientens tolerabilitet (se tabel 6 samt pkt. 
Patients with moderate or severe hepatic impairment should be started on Bortezomib SUN at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Almindelig Dyspnø*, epistaxis, øvre/nedre luftvejsinfektion*, hoste* 
Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
RR (post-induktion) *CR+nCR 
RR (Post-induction) *CR+nCR
Følgende lægemidler administreres som intravenøse infusioner på dag 1 i hver 3-ugers behandlingscyklus med Bortezomib SUN: rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m2. 
The following medicinal products are administered on day 1 of each Bortezomib SUN 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Både BzmbR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i BzmbR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen. 
Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
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 "matchet par"analyse for at sammenligne resultaterne fra den ikke-randomiserede arm med bortezomib i kombination med dexamethason (åbent fase II-studie MMY-2045) med resultaterne fra bortezomibmonoterapiarmene 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.
Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i BzmbR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik 2 supplerende cyklusser. 
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzmbR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få Bortezomib SUN 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 SUN intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
I tilfælde af bortezomib-relaterede neuropatiske smerter og/eller perifer neuropati holdes og/eller modificeres Bortezomib SUN som beskrevet i tabel 1. 
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib SUN as outlined in Table 1.
I alt har 74 vurderbare patienter fået dexamethason sammen med bortezomib. 
A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Uge Bzmb (1,3 mg/m2) Dag 1, 4 
Week Bzmb (1.3 mg/m2) Day 1, 4
Dagligt 
Daily
Fertilitet Der er ikke udført fertilitetsstudier med bortezomib (se pkt. 
Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Bortezomib SUN skal rekonstitueres af sundhedspersonale (se pkt. 
Bortezomib SUN must be reconstituted by a healthcare professional (see section 6.6).
Et risikoforhold på mindre end 1 indikerer en fordel for VMP. c Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: β2-mikroglobulin, albumin og region d p-værdi for responsrate (CR+PR) fra Cochran-Mantel-Haenszel chi-square-test justeret for stratifikationsfaktorer. 
A hazard ratio less than 1 indicates an advantage for VMP c Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response.
Thalidomid administreres oralt med 50 mg dagligt på dag 1-14, og hvis det tåles, øges dosis til 100 mg dagligt på dag 15-28, hvorefter dosis kan øges yderligere til 200 mg dagligt 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).
Der foreligger begrænsede oplysninger om bortezomib til genbehandling af recidiverende myelomatose. 
Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Bortezomib intravenøs gruppe 
Bortezomib intravenous arm
Der findes yderligere oplysninger i produktresuméet for rituximab. 
Refer to the Summary of Product Characteristics of rituximab for more information.
En statistisk signifikant forskel i CR+nCR blev observeret 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.
1.3 Den rekonstituerede opløsning er uden konserveringsmidler og skal anvendes umiddelbart efter præparation. 
1.3 The reconstituted solution is preservative free and should be used immediately after preparation.
Der administreres fire behandlingscyklusser af denne kombinationsbehandling. 
Four treatment cycles of this combination therapy are administered.
Trombocyttallet var lavest på dag 11 i hver cyklus af bortezomib-behandlingen 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.
Mediana responsvarighed 
Mediana response duration
Forkortelser: SGOT = serum-glutamin-oxalsyretransaminase; ASAT = aspartat-aminotransferase; ULN = øvre grænse for normalområdet. 
AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Tabel 6: Anbefalet justering af initialdosis for Bortezomib SUN hos patienter med nedsat leverfunktion Grad af leverfunktionsnedsættelse* 
Table 6: Recommended starting dose modification for Bortezomib SUN in patients with hepatic impairment Grade of hepatic impairment*
For studiet LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), præsenteres forekomsten af perifer neuropati i kombinationsregimerne 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:
Hos patienter med MCL (studie LYM-3002) var forekomsten af herpes zoster-infektion 6,7 % i BzmbR-CAP-armen og 1,2 % i R-CHOP-armen (se pkt. 
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzmbR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
- Skyl det intravenøse kateter igennem med steril 9 mg/ml (0,9 %) natriumchloridinjektionsvæske. 
- Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Bortezomib kan forbindes med træthed (meget almindeligt), svimmelhed (almindeligt), besvimelse (ikke almindeligt) og ortostatisk/postural hypotension eller sløret syn (almindeligt). 
Bortezomib may be associated with fatigue very commonly, dizziness commonly, syncope uncommonly and orthostatic/postural hypotension or blurred vision commonly.
Der er rapporteret sjældne tilfælde af akut diffus lungesygdom (infiltration) med ukendt ætiologi, f.eks. pneumonitis, interstitiel pneumoni, lungeinfiltration og ARDS (Acute Respiratory Distress Syndrome) hos patienter i bortezomib-behandling (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).
Patienterne fik administreret intravenøse doser bortezomib på 0,7 til 1,3 mg/m2 to gange ugentligt. 
Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Den normale startdosis Bortezomib SUN er 1,3 mg/m2 legemsoverflade to gange om ugen. 
The usual starting dose of Bortezomib SUN is 1.3 mg/m2 body surface area twice a week.
Bortezomib SUN-behandlingen skal indstilles, indtil symptomerne på toksiciteten er bedret til grad 2 eller bedre. 
Bortezomib SUN therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
* Opdatering af overlevelsesdata baseret på en median opfølgning på 60,1 måneder. 
* Survival update based on a median duration of follow-up at 60.1 months mo: months
Sjælden Aktivering af makrofager 
Macrophage activation
Bortezomib SUN indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer. 
Bortezomib SUN contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Den gennemsnitlige distributionsvolumen (Vd) for bortezomib var 1.659-3.294 l efter indgift af enkeltdoser eller gentagne intravenøse doser på 1,0 mg/m2 eller 1,3 mg/m2 til patienter med myelomatose. 
Distribution The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
• rådgivning om reduktion af risikoen for at forveksle sprøjter til i.v. 
• advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Brochuren om rekonstitution, dosering og administration skal indeholde følgende hovedpunkter: 
• Induction Transplant Regimens Graph The Reconstitution, dosing and administration booklet shall contain the following key elements:
I fase III-studiet havde patienter, der fik bortezomib subkutant, sammenlignet med patienter, der fik bortezomib intravenøst, en 13 % lavere samlet forekomst af behandlingsrelaterede bivirkninger i form af toksicitet af grad 3 eller derover 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.
> 3 x ULN Alle 
> 3 x ULN
Hazard-ratiob (95 % CI) p-værdic a Kaplan-Meier-estimat. 
Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
sammen med lægemidlerne dexamethason eller dexamethason sammen med thalidomid til patienter, hvis sygdom ikke tidligere er blevet behandlet, og før de får højdosiskemoterapi med transplantation af blodstamceller (induktionsbehandling). 
in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
*RR (post-induktion) CR+nCR 
*RR (Post-induction) CR+nCR
Bortezomibs sikkerhed og virkning hos børn under 18 år er ikke klarlagt (se pkt. 
The safety and efficacy of bortezomib in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Hver pakning Bortezomib SUN 3,5 mg pulver til injektionsvæske, opløsning, indeholder et 10 ml hætteglas med lysegrønt aluminiumslåg i en gennemsigtig blisterpakning. 
Each carton of Bortezomib SUN 3.5 mg powder for solution for injection contains a clear glass 10 ml vial closed with a light green aluminium cap, in a transparent blister pack.
Bortezomib SUN er til intravenøs eller subkutan anvendelse. 
Bortezomib SUN is for intravenous or subcutaneous use.
Fra studier, hvor bortezomib blev administreret som induktionsbehandling i kombination med dexamethason (studie IFM-2005-01) og dexamethason-thalidomid (studie MMY-3010), præsenteres 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:
Hos patienter, der udvikler PRES, skal behandlingen med bortezomib seponeres. 
In patients developing PRES, bortezomib should be discontinued.
Dog er der påvist kemisk og fysisk stabilitet for det rekonstituerede produkt i 8 timer ved 25 ºC i det originale hætteglas og/eller en sprøjte. 
However, the chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours at 25°C stored in the original vial and/or a syringe.
Bortezomib SUN er kun til engangsbrug. 
Bortezomib SUN is for single use only.
En statistisk signifikant forskel i CR+nCR blev observeret til fordel for gruppen, der fik bortezomib i kombination med dexamethason og thalidomid. 
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Patienter med ≥ grad 2 perifer neuropati ved baseline eller trombocyttal < 50 x 109/l indgik ikke. 
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
I studiet IFM-2005-01 blev bortezomib i kombination med dexamethason [BzmbDx, n=240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n=242]. 
In study IFM-2005-01 bortezomib combined with dexamethasone [BzmbDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Bortezomib SUN må ikke indgives via andre administrationsveje. 
Bortezomib SUN should not be given by other routes.
• at eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af Bortezomib SUN 3,5 mg bør indberettes. 
• to report any adverse event, or medication error experienced with the administration of Bortezomib SUN 3.5 mg.
b Estimatet af hazard-ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: β2mikroglobulin, albumin og region. 
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin,
Bzmb= Bortezomib SUN; 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. 
Bzmb=Bortezomib SUN; 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.
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, lymfoid vævsatrofi og hæmatopoietisk knoglemarvshypocellularitet, 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.
Hvis den rekonstituerede opløsning ikke bliver brugt med det samme, er opbevaringstider og opbevaringsforhold efter rekonstitution før anvendelsen brugerens ansvar. 
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Subkutan anvendelse: Tilsæt 1,4 ml 0,9 % natriumchlorid-injektionsvæske, så den endelige koncentration bliver 2,5 mg/ml. 
Subcutaneous use: Add 1.4 ml 0.9% sodium chloride to make 2.5 mg/ml final concentration.
Hvis du har brugt for meget Bortezomib SUN 
If you are given too much Bortezomib SUN
I studier med patienter med recidiverende myelomatose, som blev behandlet med bortezomib, og med patienter med tidligere ubehandlet MCL, som blev behandlet med bortezomib i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (BzmbR-CAP), var en af de hyppigste hæmatologiske bivirkninger forbigående trombocytopeni. 
In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
ORe (95 % CI)=1,688 p-værdig < 0,007 
ORe (95% CI)=1.688 p-valueg=0.007
Progressiv myelomatose - Når Bortezomib SUN gives alene, vil du få 4 doser Bortezomib SUN intravenøst eller subkutant på dag 1, dag 4, dag 8 og dag 11 efterfulgt af en pause på 10 dage uden behandling. 
Progressive multiple myeloma - When Bortezomib SUN is given alone, you will receive 4 doses of Bortezomib SUN intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Den anslåede 4-års-overlevelsesrate var 53,9 % i R-CHOP-gruppen og 64,4 % i BzmbR-CAP-gruppen. 
There was a trend towards prolonged overall survival favouring the BzmbR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BzmbR-CAP group.
Du vil derfor få taget regelmæssige blodprøver før og under din behandling med Bortezomib SUN for at få kontrolleret niveauet af dine blodlegemer. 
Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly.
Klinisk virkning hos tidligere ubehandlede myelomatosepatienter Et prospektivt, internationalt, randomiseret (1:1), åbent klinisk fase III-studie (MMY-3002 VISTA) med 682 patienter blev gennemført for at bestemme, om bortezomib (1,3 mg/m2 som intravenøs injektion) i kombination med melphalan (9 mg/m2) og prednison (60 mg/m2) medførte en forbedring i tid til progression (TTP) ved sammenligning 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/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.
Bortezomib SUN-behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet. 
Withhold Bortezomib SUN treatment until symptoms of toxicity have resolved.