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SC versus IV Isatuximab i kombination med pomalidomid og dexamethason i RRMM (IRAKLIA)

10. august 2026 opdateret af: Sanofi

Et randomiseret, fase 3, åbent studie, der evaluerer subkutan versus intravenøs administration af isatuximab i kombination med pomalidomid og dexamethason hos voksne patienter med recidiverende og/eller refraktært myelomatose (RRMM)

Dette er et randomiseret, multicenter, fase 3, åbent studie, der evaluerer subkutan (SC) versus intravenøs (IV) administration af isatuximab i kombination med pomalidomid og dexamethason (Pd) hos RRMM-patienter (undersøgelsesdeltagere), som har modtaget mindst 1 tidligere behandlingslinje inklusive lenalidomid og en proteasomhæmmer (PI). Kvalificerede deltagere vil blive randomiseret 1:1 i 1 af 2 undersøgelsesarme:

Arm SC: Isatuximab SC + Pd

Arm IV: Isatuximab IV + Pd

Deltagerne får lov til at fortsætte behandlingen indtil sygdomsprogression, uacceptable bivirkninger (AE'er), deltageranmodning om at seponere behandlingen eller enhver anden grund, alt efter hvad der kommer først.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

To undersøgelsesarme vil blive behandlet i 4-ugers cyklusser indtil sygdomsprogression, uacceptable bivirkninger (AE'er), deltageranmodning om at seponere behandlingen eller enhver anden grund, alt efter hvad der kommer først.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

531

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • Buenos Aires, Argentina, 1181
        • Investigational Site Number : 0320002
      • Buenos Aires, Argentina, 1180
        • Investigational Site Number : 0320008
      • Buenos Aires, Argentina, 1280
        • Investigational Site Number : 0320007
      • Buenos Aires, Argentina, 1417
        • Investigational Site Number : 0320003
      • Buenos Aires, Argentina, 1426
        • Investigational Site Number : 0320004
      • Buenos Aires, Argentina, 1430
        • Investigational Site Number : 0320001
      • Buenos Aires, Argentina, 1431
        • Investigational Site Number : 0320005
      • Córdoba, Argentina, 5000
        • Investigational Site Number : 0320010
      • Mendoza, Argentina, 5501
        • Investigational Site Number : 0320009
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Investigational Site Number : 0320006
  • Australien
    • New South Wales
      • Liverpool, New South Wales, Australien, 2170
        • Investigational Site Number : 0360007
      • Waratah, New South Wales, Australien, 2298
        • Investigational Site Number : 0360004
      • Wollongong, New South Wales, Australien, 2500
        • Investigational Site Number : 0360003
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Investigational Site Number : 0360008
    • Victoria
      • Melbourne, Victoria, Australien, 3004
        • Investigational Site Number : 0360006
      • Melbourne, Victoria, Australien, 3065
        • Investigational Site Number : 0360009
      • Richmond, Victoria, Australien, 3121
        • Investigational Site Number : 0360001
  • Brasilien
      • Rio de Janeiro, Brasilien, 22775-001
        • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
      • São Paulo, Brasilien, 04537-080
        • Clinica São Germano- Site Number : 0760001
    • Ceará
      • Fortaleza, Ceará, Brasilien, 60115-280
        • Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
    • Pernambuco
      • Recife, Pernambuco, Brasilien, 51020-280
        • MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90880-480
        • Hospital Mae de Deus- Site Number : 0760003
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brasilien, 24020-096
        • CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Investigational Site Number : 1240001
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Investigational Site Number : 1240004
      • Montreal, Quebec, Canada, H1T 2M4
        • Investigational Site Number : 1240003
  • Chile
    • La Araucanía
      • Temuco, La Araucanía, Chile, 4780000
        • Investigational Site Number : 1520001
    • Reg Metropolitana de Santiago
      • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
        • Investigational Site Number : 1520002
      • Santiago, Reg Metropolitana de Santiago, Chile, 6900941
        • Investigational Site Number : 1520003
      • Santiago, Reg Metropolitana de Santiago, Chile, 7620001
        • Investigational Site Number : 1520006
      • Santiago, Reg Metropolitana de Santiago, Chile, 8380455
        • Investigational Site Number : 1520004
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2540364
        • Investigational Site Number : 1520005
  • Det Forenede Kongerige
    • Derbyshire
      • Derby, Derbyshire, Det Forenede Kongerige, DE22 3NE
        • Investigational Site Number : 8260003
    • England
      • Birmingham, England, Det Forenede Kongerige, B15 2TH
        • Investigational Site Number : 8260004
    • Leicestershire
      • Leicester, Leicestershire, Det Forenede Kongerige, LE1 5WW
        • Investigational Site Number : 8260002
    • London, City of
      • London, London, City of, Det Forenede Kongerige, W12 0HS
        • Investigational Site Number : 8260005
    • Norfolk
      • Norwich, Norfolk, Det Forenede Kongerige, NR4 7UY
        • Investigational Site Number : 8260001
  • Forenede Stater
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic in Florida- Site Number : 8400008
      • Plantation, Florida, Forenede Stater, 33322
        • Boca Raton Clinical Research Associates- Site Number : 8400030
    • Mississippi
      • Hattiesburg, Mississippi, Forenede Stater, 39401
        • Hattiesburg Clinic- Site Number : 8400006
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07962
        • Atlantic Health System- Site Number : 8400005
    • New York
      • Albany, New York, Forenede Stater, 12206
        • New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28207
        • Novant Health Neurology & Sleep- Site Number : 8400014
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Gabrail Cancer Center- Site Number : 8400027
      • Fairfield, Ohio, Forenede Stater, 45014
        • Oncology Hematology Care - Fairfield- Site Number : 8400016
    • South Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Regional Medical Center- Site Number : 8400002
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas - Southwestern Medical Center- Site Number : 8400024
      • San Antonio, Texas, Forenede Stater, 78240
        • Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84108
        • Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
  • Frankrig
      • Nantes, Frankrig, 44093
        • Investigational Site Number : 2500002
      • Paris, Frankrig, 75571
        • Investigational Site Number : 2500005
      • Poitiers, Frankrig, 86021
        • Investigational Site Number : 2500001
      • Saint-Priest-en-Jarez, Frankrig, 42270
        • Investigational Site Number : 2500009
      • Toulouse, Frankrig, 31059
        • Investigational Site Number : 2500003
      • Tours, Frankrig, 37032
        • Investigational Site Number : 2500007
  • Grækenland
      • Athens, Grækenland, 106 76
        • Investigational Site Number : 3000002
      • Athens, Grækenland, 115 28
        • Investigational Site Number : 3000001
      • Pátrai, Grækenland, 265 04
        • Investigational Site Number : 3000003
      • Thessaloniki, Grækenland, 570 10
        • Investigational Site Number : 3000004
  • Italien
      • Bologna, Italien, 40138
        • Investigational Site Number : 3800002
      • Brescia, Italien, 25123
        • Investigational Site Number : 3800005
      • Pavia, Italien, 27100
        • Investigational Site Number : 3800003
    • Ancona
      • Torette, Ancona, Italien, 60020
        • Investigational Site Number : 3800004
    • Reggio Emilia
      • Meldola, Reggio Emilia, Italien, 47014
        • Investigational Site Number : 3800001
    • Roma
      • Rome, Roma, Italien, 00168
        • Investigational Site Number : 3800006
  • Japan
      • Kyoto, Japan, 603-8151
        • Investigational Site Number : 3920003
      • Osaka, Japan, 530-8480
        • Investigational Site Number : 3920011
      • Tokyo, Japan, 150-8935
        • Investigational Site Number : 3920004
      • Yamagata, Japan, 990-9585
        • Investigational Site Number : 3920009
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Investigational Site Number : 3920001
    • Chiba
      • Kamogawa, Chiba, Japan, 296-8602
        • Investigational Site Number : 3920007
    • Ibaraki
      • Higashiibaraki, Ibaraki, Japan, 311-3117
        • Investigational Site Number : 3920005
    • Iwate
      • Yahaba, Iwate, Japan, 028-3695
        • Investigational Site Number : 3920010
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-8533
        • Investigational Site Number : 3920012
    • Okayama-ken
      • Okayama, Okayama-ken, Japan, 701-1192
        • Investigational Site Number : 3920002
  • Kina
      • Beijing, Kina, 100191
        • Investigational Site Number : 1560022
      • Beijing, Kina, 100034
        • Investigational Site Number : 1560001
      • Changsha, Kina, 410013
        • Investigational Site Number : 1560010
      • Guangzhou, Kina, 510060
        • Investigational Site Number : 1560006
      • Hangzhou, Kina, 310003
        • Investigational Site Number : 1560002
      • Nanchang, Kina, 330006
        • Investigational Site Number : 1560020
      • Nanning, Kina, 530021
        • Investigational Site Number : 1560019
      • Qingdao, Kina, 266011
        • Investigational Site Number : 1560011
      • Shenyang, Kina, 110004
        • Investigational Site Number : 1560013
      • Tianjin, Kina, 300020
        • Investigational Site Number : 1560007
      • Tianjin, Kina, 300060
        • Investigational Site Number : 1560018
      • Tianjin, Kina, 300052
        • Investigational Site Number : 1560009
      • Wuhan, Kina, 430022
        • Investigational Site Number : 1560003
      • Wuhan, Kina, 430030
        • Investigational Site Number : 1560008
      • Zhengzhou, Kina, 450008
        • Investigational Site Number : 1560004
  • Norge
      • Oslo, Norge, 0450
        • Investigational Site Number : 5780001
      • Ålesund, Norge, 6017
        • Investigational Site Number : 5780002
  • Polen
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-501
        • Investigational Site Number : 6160005
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 50-088
        • Investigational Site Number : 6160004
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-081
        • Investigational Site Number : 6160001
  • Spanien
      • Madrid, Spanien, 28034
        • Investigational Site Number : 7240005
      • Salamanca, Spanien, 37007
        • Investigational Site Number : 7240002
    • Almería
      • Murcia, Almería, Spanien, 30120
        • Investigational Site Number : 7240006
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spanien, 08916
        • Investigational Site Number : 7240004
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Investigational Site Number : 7240003
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Investigational Site Number : 7240001
  • Sverige
      • Borås, Sverige, 501 82
        • Investigational Site Number : 7520001
      • Huddinge, Sverige, 141 57
        • Investigational Site Number : 7520003
  • Taiwan
      • Kaohsiung City, Taiwan, 833
        • Investigational Site Number : 1580001
      • Tainan, Taiwan, 704
        • Investigational Site Number : 1580005
      • Taipei, Taiwan, 100
        • Investigational Site Number : 1580002
  • Tjekkiet
      • Brno, Tjekkiet, 625 00
        • Investigational Site Number : 2030005
      • Olomouc, Tjekkiet, 779 00
        • Investigational Site Number : 2030003
      • Ostrava, Tjekkiet, 708 52
        • Investigational Site Number : 2030006
      • Prague, Tjekkiet, 128 08
        • Investigational Site Number : 2030004
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06010
        • Investigational Site Number : 7920007
      • Ankara, Tyrkiet (Türkiye), 06200
        • Investigational Site Number : 7920009
      • Istanbul, Tyrkiet (Türkiye), 34093
        • Investigational Site Number : 7920003
      • Istanbul, Tyrkiet (Türkiye), 34098
        • Investigational Site Number : 7920005
      • Istanbul, Tyrkiet (Türkiye), 34214
        • Investigational Site Number : 7920008
      • Istanbul, Tyrkiet (Türkiye), 34381
        • Investigational Site Number : 7920001
      • Izmir, Tyrkiet (Türkiye), 35100
        • Investigational Site Number : 7920004
  • Tyskland
      • Dresden, Tyskland, 01307
        • Investigational Site Number : 2760005
      • Heidelberg, Tyskland, 69120
        • Investigational Site Number : 2760003
      • Lübeck, Tyskland, 23562
        • Investigational Site Number : 2760006
      • Nuremberg, Tyskland, 90419
        • Investigational Site Number : 2760007
  • Ungarn
      • Budapest, Ungarn, 1097
        • Investigational Site Number : 3480004
      • Budapest, Ungarn, 1085
        • Investigational Site Number : 3480002
      • Kaposvár, Ungarn, 7400
        • Investigational Site Number : 3480003
      • Pécs, Ungarn, 7623
        • Investigational Site Number : 3480008
      • Szombathely, Ungarn, 9700
        • Investigational Site Number : 3480006
      • Székesfehérvár, Ungarn, 8000
        • Investigational Site Number : 3480005

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltagere med myelomatose, som har modtaget mindst én tidligere behandlingslinje, inklusive lenalidomid og en proteasomhæmmer, og med målbart serum M-protein (≥ 0,5 g/dL) og/eller urin M-protein (≥ 200 mg/24 timer) og/eller serumfri let kæde (FLC)-assay (Involveret FLC-assay ≥10 mg/dL og unormalt serum-FLC-forhold (1,65))

Ekskluderingskriterier:

  • Deltagere under 18 år, deltagere med Eastern Cooperative Oncology Group præstationsstatus mere end 2
  • Primære refraktære myelomatose deltagere
  • Deltagerne er refraktære over for anti-CD38 med en udvaskningsperiode på mindre end 9 måneder eller intolerante over for anti-CD38 mAb-midler
  • Tidligere behandling med pomalidomid
  • Deltagere med utilstrækkelige biologiske tests.
  • Betydelig hjertedysfunktion
  • Deltagere diagnosticeret eller behandlet for en anden cancer inden for 3 år før randomisering med undtagelse af fuldstændig resektion af basalcellekarcinom eller pladecellecarcinom i huden og in situ malignitet eller lavrisiko prostatacancer efter kurativ behandling
  • Samtidig plasmacelleleukæmi
  • Aktiv primær amyloid-light (AL) amyloidose
  • Kendt erhvervet immundefekt syndrom (AIDS)-relateret sygdom eller kendt human immundefekt virus (HIV) sygdom, der kræver antiviral behandling
  • Kend aktiv Hepatitis A-infektion. Aktuel aktiv eller kronisk hepatitis B (HBV) eller hepatitis C (HCV) infektion. Deltagere med kronisk HBV- eller HCV-sygdom, der kontrolleres under antiviral terapi, er tilladt.
  • Kvinder i den fødedygtige alder eller mandlige deltagere med kvinder i den fødedygtige alder, som ikke er enige om at bruge en højeffektiv præventionsmetode

Ovenstående information er ikke beregnet til at indeholde alle overvejelser, der er relevante for en deltagers potentielle deltagelse i et klinisk forsøg

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Isatuximab intravenøst ​​(IV)
Isatuximab-dosis vil blive administreret via IV-infusion ugentligt i 4 uger under cyklus 1 (dage 1, 8, 15 og 22) og dag 1 og 15 i efterfølgende cyklusser. Hver cyklus vil vare 28 dage. Pomalidomid-dosis vil blive indtaget oralt på dag 1 til dag 21 i hver cyklus på det tidspunkt, der er mest bekvemt for deltagerne før eller efter administration af isatuximab, helst på samme tidspunkt hver dag. Dexamethason vil blive indtaget oralt på dag 1, 8, 15 og 22 (gentages hver 28. dag). Deltagerne kan modtage andre behandlinger som baggrundsbehandling og/eller redningsmedicin.
Medicin: Dexamethason
Lægemiddelform: Tablet; Administrationsvej: Oral
Medicin: Pomalidomid
Farmaceutisk form: hårde kapsler; Administrationsvej: Oral
Andre navne:
  • Pomalyst eller tilsvarende
Medicin: Isatuximab IV
Lægemiddelform: Koncentrat opløsning til IV infusion; Administrationsvej: Intravenøs
Andre navne:
  • SAR650984
  • SARCLISA®
Medicin: Dexamethason
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Oral; Auxiliary Medicinal Product (AxMP) dvs. baggrundsbehandling; ATC-kode: H02AB02
Medicin: Montelukast
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Oral; AxMP dvs. baggrundsbehandling; ATC-kode: R03DC03
Medicin: Paracetamol / Acetaminophen
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Oral; AxMP dvs. baggrundsbehandling; ATC-kode: N02BE01
Medicin: Diphenhydramin
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Indgivelsesvej: Som præmedicinering - oral; til håndtering af infusionsreaktioner-IV (eller oral tilsvarende); AxMP dvs. baggrundsbehandling og redningsmedicin (i tilfælde af infusionsreaktioner); ATC-kode: R06AA02
Medicin: Methylprednisolon
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Som præmedicinering-IV; til håndtering af infusionsreaktioner- IV (eller oral tilsvarende); AxMP dvs. baggrundsbehandling og redningsmedicin (i tilfælde af infusionsreaktioner); ATC-kode: H02AB04
Eksperimentel: Isatuximab Subcutaneous (SC)
Isatuximab dose will administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
Medicin: Isatuximab SC
Lægemiddelform: Opløsning til subkutan administration; Administrationsvej: Subkutan (SC)
Andre navne:
  • SAR650984
Medicin: Dexamethason
Lægemiddelform: Tablet; Administrationsvej: Oral
Medicin: Pomalidomid
Farmaceutisk form: hårde kapsler; Administrationsvej: Oral
Andre navne:
  • Pomalyst eller tilsvarende
Medicin: Dexamethason
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Oral; Auxiliary Medicinal Product (AxMP) dvs. baggrundsbehandling; ATC-kode: H02AB02
Medicin: Montelukast
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Oral; AxMP dvs. baggrundsbehandling; ATC-kode: R03DC03
Medicin: Paracetamol / Acetaminophen
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Oral; AxMP dvs. baggrundsbehandling; ATC-kode: N02BE01
Medicin: Diphenhydramin
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Indgivelsesvej: Som præmedicinering - oral; til håndtering af infusionsreaktioner-IV (eller oral tilsvarende); AxMP dvs. baggrundsbehandling og redningsmedicin (i tilfælde af infusionsreaktioner); ATC-kode: R06AA02
Medicin: Methylprednisolon
Farmaceutisk form: Som pr. lokalt kommercielt produkt; Administrationsvej: Som præmedicinering-IV; til håndtering af infusionsreaktioner- IV (eller oral tilsvarende); AxMP dvs. baggrundsbehandling og redningsmedicin (i tilfælde af infusionsreaktioner); ATC-kode: H02AB04

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet responsrate (ORR)
Tidsramme: Fra første dosis af studiemedicinering (dag 1) op til PCD (06-nov-2024), ca. 28 måneder
ORR af uafhængig gennemsynskomité (IRC) ved brug af 2016 internationale myelom arbejdsgruppes (IMWG) kriterier: Procentdel af deltagere med komplet respons (CR), stringent CR (sCR), meget god partiell respons (VGPR) & partiell respons (PR). CR: negativ immunfiksering på serum og urin, forsvinden af eventuelle blødvæv plasmacytomer (STP), <5% plasmaceller i knoglemarv (BM) aspirater & et normalt frit letkæde (FLC) forhold (0,26-1,65). sCR: CR plus ingen klonale celler i BM biopsi. VGPR: serum & urin M-protein detekterbart ved immunfiksering, ikke elektroforese; >=90% reduktion i serum M-protein plus urin M-protein niveau <100mg/24time(t); >=90% fald i summen af maksimal vinkelret diameter (SPD) sammenlignet med baseline i STP; kun FLC: >=90% fald i forskellen mellem involverede og uinvolverede FLC-niveauer. PR: >=50% reduktion af serum M-protein og reduktion i 24t urin M-protein med >=90% eller til <200mg/24t. Ud over ovenstående, hvis til stede ved baseline, >=50% reduktion i størrelsen SPD af STPs også påkrævet.
Fra første dosis af studiemedicinering (dag 1) op til PCD (06-nov-2024), ca. 28 måneder
Observeret koncentration før dosering (Ctrough) af Isatuximab ved steady state
Tidsramme: Før dosis ved cyklus 6 dag 1
Ctrough ved steady state var den observerede plasmakoncentration målt før dosis på Cyklus 6 Dag 1 (svarende til før Cyklus 6 Dag 1) af isatuximab administrationsdosis.
Før dosis ved cyklus 6 dag 1

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ctrough af Isatuximab efter 4 uger (CT4W)
Tidsramme: Præ-dose ved cyklus 2 dag 1 (ved 4 uger)
CT4W var de observerede plasmakoncentrationer indsamlet før dosis på Cyklus 2 Dag 1 (svarende til før Cyklus 2 Dag 1) af isatuximab administrationsdosis.
Præ-dose ved cyklus 2 dag 1 (ved 4 uger)
Procentdel af deltagere, der svarede Meget tilfreds og Tilfreds på 'Patientoplevelse og tilfredshedsspørgeskema (PESQ-FU)': Tilfredshed med injektionsmetode' (Punkt-8) ved Cyklus 5 Dag 15
Tidsramme: Cykel 5 Dag 15
PESQ-FU, som består af 9 emner, er designet til at følge op på deltagernes oplevelse og tilfredshed vedrørende injektionsmetoden (ubehag, smerte, bivirkninger, tidsbesparelse og tilfredshed) og studiemedicinen (bivirkninger, værd at tage, tilfredshed og anbefaling). Dette spørgeskema er tilpasset på baggrund af kvalitative interviews med onkologideltagere. Svarene på 'tilfredshed med injektionsmetoden' blev registreret som 'meget tilfreds, tilfreds, hverken tilfreds eller utilfreds, utilfreds og meget utilfreds' på specificerede tidspunkter. Den samlede procentdel af deltagere, der var meget tilfredse og tilfredse med injektionsmetoden (emne-8) på cyklus 5 dag 15, rapporteres her. Procentdele er afrundet til nærmeste tiendedel.
Cykel 5 Dag 15
Ctrough for Isatuximab
Tidsramme: Før dosis på cyklus 1 dag 8, 15 og 22, cyklus 2 til 5 dag 1 og 15, cyklus 6, 7, 8, 9, 12, 15, 18, 21, 24 og 27 dag 1
Plasmaprøver blev indsamlet på specificerede tidspunkter for vurdering af Ctrough.
Før dosis på cyklus 1 dag 8, 15 og 22, cyklus 2 til 5 dag 1 og 15, cyklus 6, 7, 8, 9, 12, 15, 18, 21, 24 og 27 dag 1
Procentdel af deltagere med svar på 'Patientforventningsspørgeskema ved baseline (PEQ-BL)'
Tidsramme: Baseline (cyklus 1 dag 1)
Procentdelen af deltagere, der svarede, at de helt enig eller enig var ved baseline med forventninger om smerter, ubehag og bivirkninger fra injektionsmetoden, at injektionsmetoden ville spare tid, at studiemedicinen kan resultere i bivirkninger og ville være værd at tage, rapporteres. PEQ-BL bestod af 7 elementer. Procentdelen af deltagere, der nogensinde har modtaget medicin via IV og/eller SC administration, rapporteres også. Procentdele afrundes til nærmeste tiendedel. Baseline-værdien blev defineret som den sidste ikke-manglende værdi indsamlet på eller før startdatoen for studiemedicin.
Baseline (cyklus 1 dag 1)
Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Antal gange i de sidste 6 måneder en deltager har modtaget pleje
Tidsramme: Baseline (cyklus 1 dag 1)
Sundhedsudnyttelse ved baseline før studielægemiddeladministration blev indsamlet via HRUPQ. Gennemsnitsantallet af gange i de sidste 6 måneder en deltager modtog pleje i en klinik eller hospitals skadestue for ethvert helbredsproblem inklusive MM eller på grund af MM og hjemmepleje fra en sygeplejerske eller anden sundhedsfaglig for ethvert helbredsproblem inklusive MM eller på grund af MM præsenteres. Baseline-værdien blev defineret som den sidste ikke-manglende værdi indsamlet på eller før startdatoen for studielægemidlet.
Baseline (cyklus 1 dag 1)
HRUPQ: Baseline Sundhedsudnyttelse: Antal nætter de seneste 6 måneder en deltager opholdt sig på hospital
Tidsramme: Baseline (cyklus 1 dag 1)
Sundhedsydelsesforbrug ved baseline før studielægemiddeladministration blev indsamlet via HRUPQ. Gennemsnitligt antal nætter i de sidste 6 måneder en deltager opholdt sig på hospital for ethvert helbredsproblem inklusive MM eller på grund af MM og opholdt sig på intensiv afdeling (ICU) for ethvert helbredsproblem inklusive MM eller på grund af MM præsenteres. Baseline-værdien blev defineret som den sidste ikke-manglende værdi indsamlet på eller før startdatoen for studielægemidlet.
Baseline (cyklus 1 dag 1)
HRUPQ: Baseline Sundhedsudnyttelse: Antal gange i de seneste 6 måneder en deltager har konsulteret en sundhedsprofessionel (HCP)
Tidsramme: Baseline (cyklus 1 dag 1)
Sundhedsudnyttelse ved baseline før studiemedicinadministration blev indsamlet via HRUPQ. Det gennemsnitlige antal gange i de sidste 6 måneder en deltager konsulterede (havde set eller talt med) følgende sundhedsprofessionelle: almen læge eller primær kliniker (PCC), som behandler en række forskellige sygdomme for ethvert helbredsproblem inklusive MM eller relateret til MM, fysioterapeut eller ergoterapeut for ethvert helbredsproblem inklusive MM eller relateret til MM, mental sundhedsprofessionel (f.eks. psykiater, psykolog, psykiatrisk sygeplejerske) for ethvert helbredsproblem inklusive MM eller relateret til MM, læge eller kliniker, som specialiserer sig i bestemte medicinske sygdomme eller problemer (specialist) for ethvert helbredsproblem inklusive MM eller relateret til MM, præsenteres. Baseline-værdien blev defineret som den sidste ikke-manglende værdi indsamlet på eller før startdatoen for studiemedicin.
Baseline (cyklus 1 dag 1)
Procentdel af deltagere, der nogensinde gik på pension under studiet baseret på HRUPQ
Tidsramme: Fra første dosis af studiemedicinadministration (dag 1) op til PCD (06-nov-2024), cirka 28 måneder
Ansættelsesstatus blev vurderet via HRUPQ. Procentdelen af deltagere, der nogensinde gik på pension under studiet, rapporteres. Procentdele er afrundet til nærmeste tiendedel.
Fra første dosis af studiemedicinadministration (dag 1) op til PCD (06-nov-2024), cirka 28 måneder
Procentdel af deltagere, der stoppede tidligt på grund af MM baseret på HRUPQ
Tidsramme: Fra første dosis af studiemedicin (dag 1) op til PCD (06-nov-2024), cirka 28 måneder
Beskæftigelse blev vurderet via HRUPQ. Procentdelen af deltagere, der gik på tidlig pension på grund af MM, rapporteres. Procentdele er afrundet til nærmeste tiendedel.
Fra første dosis af studiemedicin (dag 1) op til PCD (06-nov-2024), cirka 28 måneder
Very Good Partial Response or Better Rate
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, <5% plasma cells in BM aspirates & normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24h;>=90% decrease in SPD compared to baseline in STP; FLC only:>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of Participants With Infusion Reactions
Tidsramme: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours. Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged [not rapidly responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: life-threatening consequences; urgent intervention indicated). Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators. Percentages are rounded off to the tenth decimal place.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Duration of Response (DOR)
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]),serum M-protein increase>=1g/dL if lowest M-component >=5g/dL, urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis. PR: as defined in OM1.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Time to First Response (TT1R)
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h. In addition to above, if present at baseline, >=50% reduction in the size SPD of STPs was also required.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Time to Best Response (TTBR)
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h. In addition to above, if present at baseline,>=50% reduction in the size SPD of STPs was also required.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Progression-free Survival (PFS)
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
PFS was defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first. Responses were determined according to IMWG criteria. PFS was censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever came first.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Overall Survival (OS)
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
OS was defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever was first.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Progression Free Survival 2 (PFS2)
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
PFS2 was defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happened first. Same censoring rule applies as in the PFS endpoint.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Tidsramme: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
Tidsramme: From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'time saving with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that they experienced time saving with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with study medication' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'study medication worth taking' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that the study medication was worth taking are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to satisfaction with study medication were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
Tidsramme: Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'recommendation of the study medication' were recorded as 'definitely yes, probably yes, unsure, probably not and definitely not' at specified timepoints. Percentage of participants who responded definitely yes and probably yes to the recommendation of study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
Tidsramme: EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
The PESQ-EOT consisting of 17 items assessed participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation) and has been adapted based on qualitative interviews with oncology participants. In addition to the above, this questionnaire also includes additional items to assess whether participants received oncology medications in the past 2 years and if a participant received both IV and SC in the past 2 years, then participant preference on injection method (whether SC or IV). Percentage of participants with response to these additional items (received oncology medications in the past 2 years via IV/SC/both and if received both IV and SC; then the participant preference on injection method) are reported here. Percentages are rounded off to the tenth decimal place.
EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
Tidsramme: EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews. It provided participant insights on the benefits and disadvantages of treatment. Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous). Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages. Mean of benefits, disadvantages and disadvantages vs benefits is presented here.
EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
Tidsramme: From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.
From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
Tidsramme: Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Physical Functioning
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of physical functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Role Functioning
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of role functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of cognitive functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Social Functioning
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of social functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Fatigue
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Pain
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Dyspnea
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Insomnia
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Appetite Loss
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Constipation
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Diarrhea
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Future Perspective
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Body Image
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for body image and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Tidsramme: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine. Change from baseline in VAS is reported here. A higher score in VAS and positive change from baseline represents a better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
ORR Based on at Least 1 Chromosomal Abnormality
Tidsramme: From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
BM aspirate was collected for fluorescent in situ hybridization for analysis of del[17p], t[4;14], t[14;16]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. [del(17p)] or [1q21+ and t(4;14) or t(14;16)] is presented. Percentages are rounded off to the tenth decimal place.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Efterforskere

  • Studieleder: Clinical Sciences & Operations, Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. juni 2022

Primær færdiggørelse (Faktiske)

6. november 2024

Studieafslutning (Anslået)

22. oktober 2027

Datoer for studieregistrering

Først indsendt

31. maj 2022

Først indsendt, der opfyldte QC-kriterier

31. maj 2022

Først opslået (Faktiske)

6. juni 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EFC15951
  • 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
  • U1111-1261-5846 (Registry Identifier: ICTRP)
  • 2023-508869-32 (EudraCT nummer: CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til data på patientniveau og relaterede undersøgelsesdokumenter, herunder den kliniske undersøgelsesrapport, undersøgelsesprotokol med eventuelle ændringer, blank case-rapportformular, statistisk analyseplan og datasætspecifikationer. Data på patientniveau vil blive anonymiseret, og undersøgelsesdokumenter vil blive redigeret for at beskytte forsøgsdeltagernes privatliv. Yderligere detaljer om Sanofis kriterier for datadeling, kvalificerede undersøgelser og proces for at anmode om adgang kan findes på: https://vivli.org.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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