FrancophonIA/ELRC3.0 huggingface dataset:
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzDx groups respectively; the majority of patients underwent one single transplant procedure.
Danish: 198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx og BzDx-gruppen fik autolog stamcelletransplantation.
English: Table 1: Recommended* posology modifications for Bortezomib Accord -related neuropathy
Danish: Tabel 1: Anbefalede* dosisændringer ved Bortezomib Accord-relateret neuropati
English: In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Danish: I et studie, hvor bortezomib-behandling blev gentaget hos 130 patienter med recidiverende myelomatose, som tidligere havde opnået mindst partielt respons med et regime, der omfattede bortezomib, var de hyppigste bivirkninger af alle grader, der indtraf hos mindst 25 % af patienterne, trombocytopeni (55 %), neuropati (40 %), anæmi (37 %), diaré (35 %) og obstipation (28 %).
English: • A severe reversible brain condition which includes seizures, high blood pressure, headaches,
Danish: - Godartede cyster - En alvorlig, reversibel tilstand i hjernen, der omfatter krampeanfald, højt blodtryk, hovedpine,
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML).
Danish: Bortezomibs farmakokinetik blev karakteriseret efter intravenøs bolus-administration af 1,3 mg/m2 to gange om ugen hos 104 pædiatriske patienter (2-16 år) med akut lymfoblastær leukæmi (ALL) eller akut myeloid leukæmi (AML).
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy
Danish: Dosisjusteringer i behandlingsforløbet og ved genoptagelse af behandling ved monoterapi
English: Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6).
Danish: Bortezomib Accord skal rekonstitueres af sundhedspersonale (se pkt.
English: Bortezomib Accord is for single use only.
Danish: Bortezomib Accord er kun til engangsbrug.
English: Reduce Bortezomib Accord to 1.0 mg/m2
Danish: Reducer Bortezomib Accord til 1,0 mg/m2
English: Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Danish: Bortezomib Accord-behandlingen skal indstilles, indtil symptomerne på toksicitet er bedret til grad 2 eller bedre.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the reconstituted solution should be used immediately after preparation.
Danish: Fra et mikrobiologisk synspunkt bør den rekonstituerede opløsning anvendes umiddelbart efter tilberedning, med mindre metoden til åbning/rekonstitution/fortynding udelukker risikoen for mikrobiel forurening.
English: IV only
Danish: Kun IV.
English: 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.
Danish: Ved efterfølgende doser lå de gennemsnitlige maksimale observerede plasmakoncentrationer på 67-106 ng/ml for en dosis på 1,0 mg/m2 og på 89-120 ng/ml for en dosis på 1,3 mg/m2.
English: The incidence of herpes zoster among patients in the Bz+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Danish: Forekomsten af herpes zoster blandt patienter i Bz+M+P-behandlingsgruppen var 17 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3 % hos patienter, der havde fået antiviral profylakse.
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib Accord together with two other medicines; melphalan and prednisone.
Danish: Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få Bortezomib Accord samtidig med to andre lægemidler; melphalan og prednison.
English: Combination therapy with melphalan and prednisone
Danish: Kombinationsbehandling med melphalan og prednison
English: • that Bortezomib Accord 1 mg is only for intravenous use
Danish: • at Bortezomib Accord 1 mg kun er til intravenøs anvendelse
English: b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Danish: Hazard ratio-estimat er baseret på en Cox-model stratificeret efter IPI-risiko og sygdomsstadie.
English: In patients aged ≥ 75 years, both regimens, BzR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Danish: Patienter ≥ 75 år tolererede begge regimer dårligere, både BzR-CAP og R-CHOP (se pkt.
English: Median PFS by investigator assessment was 30.7 months in the BzR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Danish: Median for investigatorbedømt PFS var 30,7 måneder i BzR-CAP-gruppen og 16,1 måneder i R-CHOP-gruppen (Hazard ratio [HR]=0,51; p < 0,001).
English: 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.
Danish: 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.
English: The duration of overall response was 21.4 months longer in the BzR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Danish: Varigheden af det samlede respons var 21,4 måneder længere i BzR-CAP-gruppen (median 36,5 måneder kontra 15,1 måneder i R-CHOP-gruppen).
English: Combination therapy with pegylated liposomal doxorubicin
Danish: Kombinationsbehandling med pegyleret liposomal doxorubicin
English: When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
Danish: Når toksiciteten er forsvundet, gives Bortezomib Accord igen, dosis reduceres til 0,7 mg/m2 en gang om ugen.
English: • Hypersensitivity (allergic reaction)
Danish: - Leverbetændelse - Alvorlig allergisk reaktion (anafylaktisk reaktion).
English: • If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib Accord dosing day (other than day 1)
Danish: • Hvis trombocyttallet er ≤ 30 × 109/l eller ANC-værdien ≤ 0,75 x 109/l på en Bortezomib Accord-dosisdag (bortset fra dag 1)
English: e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Danish: Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er benyttet, med IPI-risiko og sygdomsstadie som stratifkationsfaktorer.
English: • different reconstitution requirements for intravenous or subcutaneous use
Danish: • at kravene til rekonstitution er forskellige ved intravenøs og subkutan anvendelse
English: The incidence of herpes zoster among patients in the BzR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Danish: Forekomsten af herpes zoster blandt patienter i BzR-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.
English: Bz= Bortezomib Accord; 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
Danish: Bz= Bortezomib Accord; 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.
English: OR; 95% CI; P valuea
Danish: OR; 95 % CI; P værdia
English: • advice on how to reduce the risk of mix-up of intravenous and subcutaneous reconstituted syringes
Danish: • rådgivning om reduktion af risikoen for at forveksle sprøjter til intravenøs og subkutan anvendelse
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2
Danish: Overvej dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2
English: Pegylated liposomal doxorubicin is administered at 30 mg/m2 on day 4 of the Bortezomib Accord treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Accord injection.
Danish: Pegyleret liposomal doxorubicin administreres i en dosis på 30 mg/ m2 på dag 4 af Bortezomib Accord behandlingscyklussen som en 1-times intravenøs infusion, der administreres efter Bortezomib Accordinjektionen.
English: Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Danish: Neutrofiltal var lavest på dag 11 i hver cyklus af bortezomib-behandlingen og var typisk vendt tilbage til baseline-niveau ved næste cyklus.
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma
Danish: Dosisjustering af kombinationsbehandling for patienter med progressiv myelomatose
English: Bortezomib Accord should not be given by other routes.
Danish: Bortezomib Accord må ikke indgives via andre administrationsveje.
English: Table 2: Recommended posology for Bortezomib Accord in combination with melphalan and prednisone
Danish: Tabel 2: Anbefalet dosering for Bortezomib Accord i kombination med melphalan og prednison
English: 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.
Danish: I fase III-studiet havde patienter, der fik bortezomib subkutant sammenlignet med som intravenøs administration 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.
English: Events (deaths) n (%) Mediana
Danish: Hændelser (dødsfald) n (%) Mediana
English: The following medicinal products are given on day 1 of each Bortezomib Accord 21-day treatment cycle as intravenous infusions:
Danish: Følgende lægemidler gives som intravenøse infusioner på dag 1 i hver 21-ugers behandlingscyklus med Bortezomib Accord:
English: Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the RCHOP group.
Danish: Både BzR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i BzR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen.
English: 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.
Danish: Den gennemsnitlige TTP var 6,5 måned for patienter i monoterapi med bortezomib sammenlignet med 9,3 måneder for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Bortezomib Accord findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Posology for patients with previously untreated mantle cell lymphoma (MCL)
Danish: Dosering til patienter med tidligere ubehandlet mantle-celle-lymfom (MCL)
English: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-valued
Danish: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-værdid
English: You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Accord for information related to these medicines before starting treatment with Bortezomib Accord.
Danish: Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med Bortezomib Accord, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med Bortezomib Accord.
English: 169d b
Danish: 169d
English: BzR-CAP
Danish: BzR-CAP R-CHOP
English: b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Danish: (95 % CI) p-værdi c a Kaplan-Meier-estimat b Estimatet af Hazard ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: β2-mikroglobulin, albumin og region.
English: • Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Danish: • Trombocyttal skal være ≥ 75x 109 celler/l hos patienter med infiltreret knoglemarv eller sekvestration af milten.
English: What you need to know before you use Bortezomib Accord Do not use Bortezomib Accord
Danish: Det skal du vide, før du begynder at bruge Bortezomib Accord Brug ikke Bortezomib Accord:
English: 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).
Danish: Bortezomib-behandling skal indstilles ved forekomst af ≥ grad 3 bortezomib-relateret ikke hæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib Accord 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).
Danish: Patienter med moderat eller alvorligt nedsat leverfunktion skal starte med en reduceret dosis af Bortezomib Accord 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.
English: The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Danish: Median OS var 30,8 måneder (95 % CI: 25,2-36,5 måneder) for patienter i monoterapi med bortezomib og 33,0 måneder (95 % CI: 28,9-37,1 måneder) for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin.
English: Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Danish: Bortezomib Accord-behandlingen skal indstilles, indtil symptomerne på toksiciteten er vurderet til grad 1 eller baseline.
English: Bortezomib Accord will be administered by a health care professional experienced in the use of cytotoxic medicines.
Danish: Bortezomib Accord vil blive givet af sundhedspersonale, som har erfaring med behandling med cytostatika.
English: The active substance is bortezomib.
Danish: - Aktivt stof: bortezomib.
English: Intravenous use.
Danish: Kun intravenøs anvendelse.
English: The other ingredient is mannitol (E421).
Danish: - Øvrige indholdsstoffer: Mannitol (E421).
English: During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Danish: Der er i kliniske studier rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika.
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Danish: Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i BzR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik 2 supplerende cyklusser.
English: • Non-haematological toxicities should have resolved to Grade 1 or baseline
Danish: • Ikke-hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline
English: 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:
Danish: For studiet LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), præsenteres forekomsten af perifer neuropati i kombinationregimerne i tabellen nedenfor:
English: If you are given Bortezomib Accord 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,
Danish: Hvis du får Bortezomib Accord 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, hovedpiner - åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - hoste og vejrtrækningsbesvær eller trykken for brystet.
English: If you have not been treated before for mantle cell lymphoma, you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Danish: Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få Bortezomib Accord intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison.
English: Patients eligible for stem cell transplantation
Danish: Patienter, som er egnede til stamcelletransplantation
English: Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Danish: Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon Sjælden Hypotyroidisme
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Danish: Patienterne fik administreret intravenøse doser bortezomib på 0,7 til 1,3 mg/m2 to gange ugentlig.
English: Note: An OR > 1 indicates an advantage for Bz-containing induction therapy
Danish: Bemærk: OR > 1 tyder på en fordel for Bz-indeholdende induktionsterapi
English: Peripheral neuropathy in combination regimens
Danish: Perifer neuropati ved kombinationsbehandlinger
English: For Bortezomib Accord dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Danish: Forjustering af Bortezomib Accord-dosis: Retningslinjerne for dosisændringer som beskrevet for monoterapi skal følges.
English: Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Danish: Du vil derfor få taget regelmæssige blodprøver før og under din behandling med Bortezomib Accord for at kontrollere niveauet af dine blodlegemer.
English: If you are given too much Bortezomib Accord
Danish: Hvis du har brugt for meget Bortezomib Accord
English: If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Danish: Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få Bortezomib Accord intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling.
English: Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
Danish: Skift behandlingsplanen for Bortezomib Accord til 1,3 mg/m2 en gang om ugen
English: Note: An OR > 1 indicates an advantage for Bz-containing induction therapy.
Danish: Bemærk: OR > 1 tyder på en fordel for Bz-indeholdende induktionsterapi.
English: Withhold Bortezomib Accord treatment until symptoms of toxicity have resolved.
Danish: Bortezomib Accord-behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet.
English: You will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Danish: Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med Bortezomib Accord for at kontrollere niveauet af dine blodlegemer.
English: Table 3: Posology modifications during subsequent cycles of Bortezomib Accord therapy in combination with melphalan and prednisone
Danish: Tabel 3: Dosisjusteringer under efterfølgende cyklusser med Bortezomib Accord i kombination med melphalan og prednison
English: The following medicinal products are administered on day 1 of each bortezomib 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Danish: Følgende lægemidler administreres som intravenøse infusioner på dag 1 i hver 3-ugers behandlingscyklus med bortezomib: rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m2.
English: n: ITT patients
Danish: n:ITT-patienter
English: The usual starting dose of Bortezomib Accord is 1.3 mg/m2 body surface area twice a week.
Danish: Den normale startdosis Bortezomib Accord er 1,3 mg/m2 legemsoverflade to gange om ugen.
English: • different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
Danish: • at kravene til rekonstitution af Bortezomib Accord 3,5 mg er forskellige ved intravenøs og subkutan anvendelse
English: Contents of the pack and other information What Bortezomib Accord contains
Danish: Pakningsstørrelser og yderligere oplysninger Bortezomib Accord indeholder:
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Danish: Hos patienter med MCL (studie LYM-3002) var forekomsten af herpes zoster-infektion 6,7 % i BzRCAP-armen og 1,2 % i R-CHOP-armen (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 1 mg
English: In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Danish: I studie MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BzTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127].