natgillin/translations-raw huggingface dataset:
• Se indlægssedlerne, der følger med bortezomib og dexamethason, for yderligere oplysninger om brug og virkning.
• See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.
• Feber, kulderystelser, ondt i halsen, hoste, mundsår eller andre tegn på infektion (skyldes færre hvide blodlegemer, der bekæmper infektioner).
• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to less white blood cells, which fight infection).
Dosisjustering eller dosisafbrydelse af pomalidomid For at påbegynde en ny cyklus af pomalidomid skal neutrofiltallet være  1 x 109/l, og trombocyttallet skal være  50 x 109/l.
To initiate a new cycle of pomalidomide, the neutrophil count must be  1 x 109/l and the platelet count must be  50 x 109/l.
For instruktioner i dosisafbrydelser eller -reduktioner for bortezomib-relaterede bivirkninger, henvises lægerne til produktresuméet for bortezomib.
For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians should refer to bortezomib Summary of Product Characteristics (SmPC).
KaplanMeier-kurven for PFS for ITT-populationen kan ses i figur 1.
KaplanMeier curve for PFS for the ITT population is provided in Figure 1.
Hazard ratio (POM+LD-Dex:HD-Dex) tosidet 95 % CI c
Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI c
Ikke almindelig Basalcellekarcinom i huden, Planocellulært karcinom i huden
Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin
• Åndenød (dyspnø).
• Shortness of breath (dyspnoea).
Alle bivirkninger /hyppighed
All Adverse Reactions /Frequency
Ingen uønskede fund blev bemærket ved op til 1000 mg/kg/dag (175 gange eksponeringen i forhold til en klinisk dosis på 4 mg).
No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio relative to a 4 mg clinical dose).
Mannitol (E421) Stivelse, prægelatineret Natriumstearylfumarat
Mannitol (E421) Starch, pregelatinised Sodium stearyl fumarate
Patienter med tidligere svært udslæt i forbindelse med lenalidomid eller thalidomid må ikke få pomalidomid (se pkt.
Patients with a history of severe rash associated with lenalidomide or thalidomide should not receive pomalidomide (see section 4.4).
I armen med Btz+LD-Dex var den mediane PFS-tid 7,1 måneder (95 % CI: 5,88;
In the Btz+LD-Dex arm, median PFS time was 7.1 months (95% CI: 5.88, 8.48).
I det embryoføtale studie af udviklingstoksicitet hos rotter blev der observeret misdannelser som manglende urinblære, manglende tyreoidea samt fusion og forkert placering af lumbale og torakale vertebrale elementer (centrale og/eller neurale buer) ved alle doseringsniveauer (25, 250 og 1000 mg/kg/dag).
In the rat embryofoetal developmental toxicity study, malformations of absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (central and/or neural arches) were observed at all dosage levels (25, 250, and 1000 mg/kg/day).
Der er blevet rapporteret svimmelhed og forvirret tilstand med pomalidomid.
Dizziness and confusional state have been reported with pomalidomide.
Fortæl det straks til lægen, hvis du bemærker nogle af disse symptomer:
Tell your doctor straightaway if you notice any of these symptoms.
For information om bortezomib, der gives i kombination med Imnovid, henvises til det relevante gældende produktresumé.
For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
Som forholdsregel skal alle mandlige patienter, der er i behandling med pomalidomid, benytte kondom under hele behandlingen, under dosisafbrydelse og i 7 dage efter behandlingsophør, hvis deres partner er gravid eller i den fertile alder og ikke bruger kontraception (se pkt.
As a precaution, all male patients taking pomalidomide should use condoms throughout treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception (see sections 4.3 and 4.4).
Undervisningsmaterialer, ordinations- og udleveringsrestriktioner For at støtte patienterne, så det undgås, at fostre udsættes for pomalidomid, vil indehaveren af markedsføringstilladelsen udlevere undervisningsmateriale til sundhedspersonale for at underbygge advarslerne vedrørende pomalidomids forventede teratogenicitet, for at rådgive om kontraception, inden behandlingen indledes, og for at rådgive om nødvendigheden af graviditetstests.
In order to assist patients in avoiding foetal exposure to pomalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of pomalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Endelig studierapport: 31. august 2023
31 August 2023
Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom infektion hos 55,0-80,2 % af patienterne (24,0-30,9 % grad 3 eller 4).
In patients receiving combination therapy with pomalidomide in clinical studies, infection occurred in 55.0-80.2% of patients (24.0-30.9% Grade 3 or 4).
Dyspepsi ≥ grad 3
Dyspepsia ≥ Grade 3
Andre alvorlige rapporterede bivirkninger omfattede pyreksi (4,0 %), infektion i de nedre luftveje (2,9 %), lungeemboli (2,9 %), influenza (2,9 %) og akut nyreskade (2,9 %).
Other serious adverse reactions reported included pyrexia (4.0%), lower respiratory tract infection (2.9%), pulmonary embolism (2.9%), influenza (2.9%), and acute kidney injury (2.9%).
I et studie af fertilitet og tidlig embryoudvikling hos rotter blev pomalidomid administreret til hanner og hunner i doser på 25, 250 og 1000 mg/kg/dag.
In a fertility and early embryonic development study in rats, pomalidomide was administered to males and females at dosages of 25, 250, and 1000 mg/kg/day.
På grund af den øgede risiko for venøs tromboemboli hos patienter med myelomatose, som tager pomalidomid og dexamethason, anbefales p-piller af kombinationstypen ikke (se også pkt.
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking pomalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also section 4.5).
Pomalidomid er kontraindiceret under graviditeten og til kvinder i den fertile alder, undtagen hvor alle betingelserne for svangerskabsforebyggelse er opfyldt, se pkt.
Pomalidomide is contraindicated during pregnancy and in women of childbearing potential, except when all the conditions for pregnancy prevention have been met, see section 4.3 and section 4.4.
• din læge vil sørge for, at der bliver udført graviditetstest før behandlingen, mindst hver 4. uge under behandlingen, og mindst 4 uger efter behandlingen er ophørt.
• your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished.
Trombocytopeni Trombocyttal < 25 x 109/l
Thrombocytopenia Platelet count < 25 x 10
Patienter med stor tumorbyrde inden behandlingen har den største risiko for at få tumorlysesyndrom.
Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
I studier blev det fundet, at pomalidomid blev fjernet ved hæmodialyse.
In studies, pomalidomide was found to be removed by haemodialysis.
Interstitiel lungesygdom (ILD - interstitial lung disease)
Interstitial lung disease (ILD)
Overvej dosisafbrydelse eller seponering af behandlingen med pomalidomid.
Consider dose interruption or discontinuation of pomalidomide treatment.
Dosisjustering af pomalidomid er ikke nødvendig for patienter med nedsat nyrefunktion.
No dose adjustment of pomalidomide is required for patients with renal impairment.
På dage med hæmodialyse bør patienterne tage deres pomalidomiddosis efter hæmodialyse.
On haemodialysis days, patients should take their pomalidomide dose following haemodialysis.
• Lavt niveau af magnesium i blodet (hypomagnesiæmi), som kan forårsage træthed, en generel svaghedsfølelse, muskelkramper, irritabilitet og kan føre til et lavt niveau af calcium i blodet (hypocalcæmi), hvilket kan forårsage følelsesløshed og/eller en stikkende fornemmelse i hænder, fødder eller læber, muskelkramper, muskelsvaghed, ørhed, forvirring.
• Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
• Alle læger, som har til hensigt at ordinere pomalidomid, og alle farmaceuter, der eventuelt udleverer pomalidomid, modtager den nedenfor beskrevne information, der stiles direkte til sundhedspersonalet, inden præparatet markedsføres.
• Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Den anbefalede dosis af dexamethason er 20 mg oralt én gang dagligt på dagene vist i tabel 1.
The recommended dose of dexamethasone is 20 mg orally once daily, on the days shown in Table 1.
• Pomalidomid i kombination med dexamethason I det randomiserede studie CC-4047-MM-003 blev 302 patienter med relaps og refraktær myelomatose eksponeret for 4 mg pomalidomid administreret én gang dagligt i 21 dage af hver 28dages cyklus i kombination med en ugentlig lav dosis af dexamethason.
• Pomalidomide in combination with dexamethasone In randomised study CC-4047-MM-003, 302 patients with relapsed and refractory multiple myeloma were exposed to 4 mg pomalidomide administered once daily for 21 days of each 28-day cycle in combination with a weekly low dose of dexamethasone.
Reducer dosis med et dosisniveau.
Decrease dose by one dose level.
6.1 Hjælpestoffer Kapselindhold
6.1 List of excipients Capsule contents
• Kvinder i den fertile alder, medmindre alle betingelserne i ”Programmet til svangerskabsforebyggelse” er opfyldt (se pkt.
• Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6).
Bortezomib (1,3 mg/m2/dosis) blev administreret til patienter i begge studiearme på dag 1, 4, 8 og 11 i en cyklus på 21-dage for cyklus 1 til 8 og på dag 1 og 8 i en cyklus på 21 dage for cyklus 9 og fremover.
Bortezomib (1.3 mg/m2/dose) was administered to patients in both study arms on Days 1, 4, 8 and 11 of a 21-day cycle for Cycles 1 to 8; and on Days 1 and 8 of a 21-day cycle for Cycles 9 and onwards.
• Hævelse forårsaget af væske.
• Swelling caused by fluid.
• Vejledning til patienter, omsorgspersoner og familiemedlemmer i håndtering af pomalidomid
• Guidance on handling pomalidomide for patients, caregivers and family members
Medianen er baseret på Kaplan-Meier-estimatet.
The median is based on the Kaplan-Meier estimate.
• Blødning eller blå mærker uden årsag, herunder næseblod og blødning fra tarmen eller maven (skyldes virkningen på blodlegemer, der kaldes ‘blodplader').
• Bleeding or bruising without a cause, including nosebleeds and bleeding from the bowels or stomach (due to effects on blood cells called ‘platelets').
Pomalidomid øger celle-medieret immunitet fra både T-celler og naturlige dræberceller (natural killer cells, NK-celler) og hæmmer monocytters produktion af proinflammatoriske cytokiner (f.eks. TNF-α og IL-6).
Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom trombocytopeni hos 27,0-36,7 % af patienterne.
In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia occurred in 27.0-36.7% of patients.
Ammoniumhydroxid (E527)
Ammonium hydroxide (E527)
• Råd om sikkerhed, som er relevante for mænd o Nødvendigheden af at undgå føtal eksponering o Nødvendigheden af at bruge kondom, hvis partneren, som der er seksuelt samvær med, er gravid eller fertil og ikke anvender nogen former for kontraception (også selvom manden er vasektomeret) ▪ Under behandlingen med pomalidomid ▪ I en uge efter sidste dosis o At han ikke må donere sæd eller sperm under behandlingen (herunder under dosisafbrydelser) og i 7 dage efter seponering af pomalidomid o At han skal informere den behandlende læge omgående, hvis hans partner bliver gravid, imens han tager eller kort tid efter, at han er ophørt med pomalidomid.
• Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had a vasectomy) ▪ During pomalidomide treatment ▪ For one week following final dose o That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment o That if his partner becomes pregnant whilst he is taking pomalidomide or shortly after he has stopped taking pomalidomide he should inform his treating doctor immediately
Ikke almindelig Nedsat appetit
Uncommon Decreased appetite
Seponer dexamethason fra behandlingsprogrammet.
Discontinue dexamethasone from treatment regimen.
I HD-Dex-armen var den mediane PFS-tid 8,0 uger (95 % CI: 7,0-9,0), og den estimerede 26-ugers hændelsesfrie overlevelsesrate var 12,15 % ±3,63 %.
In the HD-Dex arm, median PFS time was 8.0 weeks (95% CI: 7.0, 9.0); the estimated 26-week event-free survival rate was 12.15% (±3.63%).
Kaplan-Meier-kurven for PFS for ITT-populationen kan ses i figur 2.
Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2.
• Forvirring.
• Feeling confused.
Niveauet for ingen observerede bivirkninger (NOAEL − No Observed Adverse Effect Level) var 0,1 mg/kg/dag (0,5 gange eksponeringen i forhold til en klinisk dosis på 4 mg).
The No Observed Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical dose).
Almindelig Forvirret tilstand
Common Confusional state
Behandling med pomalidomid kombineret med bortezomib og dexamethason bør gives, indtil der opstår sygdomsprogression eller uacceptabel toksicitet.
Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
• Lavt niveau af fosfat i blodet (hypofosfatæmi), som kan forårsage muskelsvaghed og irritabilitet eller forvirring.
• Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
• Højt niveau af calcium i blodet (hypercalcæmi), hvilket kan forårsage langsommere reflekser og svaghed i skeletmuskulaturen.
• High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
Kriterier for, at kvinder ikke er i den fertile alder
Criteria for women of non-childbearing potential
Afbryd dosis, indtil symptomerne forsvinder.
Interrupt dose until symptoms resolve.
Mænd Imnovid udskilles i sæden hos mennesker.
Men Imnovid passes into human semen.
For hvert efterfølgende fald < 25 x 10
For each subsequent drop < 25 x 109/l
Almindelig Neutropenisk sepsis Bronkopneumoni Bronkitis
Neutropenic sepsis Bronchopneumonia Bronchitis
• Lavt blodtryk, hvilket kan forårsage svimmelhed eller besvimelse.
• Low blood pressure, which may cause dizziness or fainting.
• At han ikke må donere sæd eller sperm under behandlingen (herunder under dosisafbrydelser) og i 7 dage efter ophør med pomalidomid
• That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment
Efter en median opfølgning på 15,9 måneder var median PFS-tid 11,20 måneder (95 % CI: 9,66; 13,73) i armen med Pom+Btz+LD-Dex.
After a median follow-up of 15.9 months, median PFS time was 11.20 months (95% CI: 9.66, 13.73) in the Pom+Btz+LD-Dex arm.
Bivirkninger rapporteret ved anvendelse efter markedsføring hos patienter behandlet med pomalidomid
ADRs reported in post-marketing use in patients treated with pomalidomide.
• Højt niveau af urinsyre i blodet, hvilket kan forårsage en form for gigt, der kaldes podagra.
• High blood levels of uric acid, which may cause a form of arthritis called gout.
Nedsat neutrofiltal Nedsat antal hvide blodlegemer Nedsat trombocyttal Forhøjet alaninaminotransferase
Neutrophil count decreased White blood cell count decreased Platelet count decreased Alanine aminotransferase increased
Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom venøse tromboemboliske hændelser (VTE) hos 3,3-11.5 % af patienterne (1,3-5,4 % grad 3 eller 4).
In patients receiving combination therapy with pomalidomide in clinical studies, venous thromboembolic events (VTE) occurred in 3.3-11.5% of patients (1.3-5.4% Grade 3 or 4).
Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom neutropeni hos op til 46,8 % af patienterne (41,7 % grad 3 eller 4).
In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in up to 46.8% of patients (41.7% Grade 3 or 4).
LD-Dex (40 mg) blev administreret én gang dagligt på dag 1, 8, 15 og 22 af en 28-dags cyklus.
LD-Dex (40 mg) was administered once per day on days 1, 8, 15 and 22 of a 28-day cycle.
• Pomalidomid i kombination med bortezomib og dexamethason De mest almindeligt rapporterede forstyrrelser i blod og lymfesystem var neutropeni (46,8 %), trombocytopeni (36,7 %) og anæmi (28,4 %).
• Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) and anaemia (28.4%).
Titandioxid (E171) Simeticon
Titanium dioxide (E171) Simeticone
Ikke anvendt lægemiddel skal afleveres på apoteket.
Unused medicinal product should be returned to the pharmacist.
• Brystsmerter eller bensmerter og hævelse, især nederst på benet eller i læggen (forårsaget af blodpropper).
• Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots).
Fordelen ved at bruge Imnovid sammen med bortezomib og dexamethason Når Imnovid anvendes sammen med bortezomib og dexamethason hos personer, som har fået mindst én anden behandling, kan det forhindre, at myelomatosen forværres:
The benefit of using Imnovid with bortezomib and dexamethasone When Imnovid is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse:
Bivirkningerne observeret hos patienter i behandling med pomalidomid plus dexamethason er opstillet nedenfor i tabel 8 efter systemorganklasse (SOC) og hyppighed for alle bivirkninger (ADR'er) samt for grad 3 eller 4 bivirkninger.
The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions.
• Virkningsundersøgelse efter tilladelse til markedsføring (PAES) MM007: For at undersøge virkningen af pomalidomid i kombination med bortezomib og dexamethason yderligere til behandling af voksne patienter med myelomatose, som har fået mindst ét tidligere behandlingsprogram, der inkluderede lenalidomid, skal indehaveren af markedsføringstilladelsen indsende den endelige analyse af OS fra det randomiserede, åbne fase III-studie MM-007.
• Post-authorisation efficacy study (PAES) MM-007: In order to further investigate the efficacy of pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide, the MAH should submit the final analysis of OS from the phase 3, randomized, open label study MM-007.
Bivirkninger observeret hos patienter behandlet med pomalidomid i kombination med bortezomib og dexamethason er anført i tabel 7 i henhold til systemorganklasse (SOC) og hyppighed for alle bivirkninger og for grad 3 eller 4 bivirkninger.
The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
• Bevidstløshed, besvimelse.
• Loss of consciousness, fainting.
Hvordan tages Imnovid
How to take Imnovid
Bronkiolitis
Bronchiolitis
Ikke almindelig Bronkitis Herpes zoster
Uncommon Bronchitis Herpes zoster
• En brochure til kvinder, som ikke er i den fertile alder
• Brochure for women patients who are not of childbearing potential
Pomalidomid dosisreduktion∞ Dosisniveau
Pomalidomide dose reduction∞ Dose level
Hvornår skal du tage Imnovid sammen med anden medicin?
When to take Imnovid with other medicines
Den anbefalede dosis af dexamethason er 40 mg oralt én gang dagligt på dag 1, 8, 15 og 22 i hver 28dages behandlingscyklus.
The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle.
Hvis en kvindelig partner til en mandlig patient, som tager pomalidomid, bliver gravid, anbefales det at henvise den kvindelige partner til en læge med speciale eller erfaring i teratologi for vurdering og rådgivning.
If pregnancy occurs in a partner of a male patient taking pomalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Meget almindelig Hypokaliæmi Hyperglykæmi
Very Common Hypokalaemia Hyperglycaemia
Ifølge en interimanalyse for samlet overlevelse (OS) med afskæring den 15. september 2018 (median opfølgning på 26,2 måneder) var median OS-tid fra Kaplan-Meier-estimater 40,5 måneder for Pom+Btz+LD-Dex-armen og 30,5 måneder for Btz+LD-Dex armen, HR = 0,91, 95 % CI: 0,70; 1,18, med en samlet hændelsesrate på 43,3 %.
As per an interim analysis for Overall Survival (OS), using a cut-off of 15 September 2018 (median follow-up period of 26.2 months), median OS time from Kaplan-Meier estimates was 40.5 months for the Pom + Btz + LD-Dex arm and 30.5 months for the Btz + LD-Dex arm; HR = 0.91, 95% CI: 0.70, 1.18, with an overall event rate of 43.3%.
For patienter >75 år er startdosis af dexamethason:
For patients >75 years of age, the starting dose of dexamethasone is:
Det primære effektendepunkt var progressionsfri overlevelse (progression free survival, PFS) vurderet af en Independent Response Adjudication Committee (IRAC) i henhold til kriterierne fra International
The primary efficacy endpoint was Progression Free Survival (PFS) assessed by an Independent Response Adjudication Committee (IRAC) according to the IMWG criteria using the intent to treat population (ITT).
• Pomalidomid i kombination med dexamethason Patienter med aktuel perifer neuropati ≥ grad 2 blev ekskluderet fra kliniske studier.
• Pomalidomide in combination with dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 were excluded from clinical studies.
Brochure til mandlige patienter
Brochure for male patients
• Han forstår nødvendigheden af at bruge kondom ved seksuelt samvær med en kvinde, som er gravid eller i den fertile alder, der ikke anvender sikker kontraception, under hele behandlingens varighed, under dosisafbrydelse og i 7 dage efter dosisafbrydelser og/eller seponering.
• He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception, throughout treatment duration, during dose interruption and for 7 days after dose interruptions and/or cessation of treatment.
Patienterne i Pom+Btz+LD-Dex-armen fik administreret 4 mg pomalidomid oralt på dag 1 til 14 i hver 21-dages cyklus.
Patients in the Pom+Btz+LD-Dex arm were administered 4 mg pomalidomide orally on Days 1 to 14 of each 21-day cycle.
Ikke almindelig Myokardieinfarkt
Uncommon Myocardial infarction