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Isatuximab SC versus IV en association avec le pomalidomide et la dexaméthasone dans le RRMM (IRAKLIA)

10 août 2026 mis à jour par: Sanofi

Une étude ouverte randomisée de phase 3 évaluant l'administration sous-cutanée par rapport à l'administration intraveineuse d'isatuximab en association avec le pomalidomide et la dexaméthasone chez des patients adultes atteints de myélome multiple récidivant et/ou réfractaire (RRMM)

Il s'agit d'une étude ouverte, randomisée, multicentrique, de phase 3 évaluant l'administration sous-cutanée (SC) versus intraveineuse (IV) d'isatuximab en association avec le pomalidomide et la dexaméthasone (Pd) chez des patients atteints de RRMM (participants à l'étude) qui ont reçu au moins 1 traitement antérieur ligne de traitement comprenant le lénalidomide et un inhibiteur du protéasome (IP). Les participants éligibles seront randomisés 1: 1 dans 1 des 2 bras d'étude :

Bras SC : Isatuximab SC + Pd

Bras IV : Isatuximab IV + Pd

Les participants seront autorisés à poursuivre le traitement jusqu'à progression de la maladie, événements indésirables (EI) inacceptables, demande du participant d'interrompre le traitement ou toute autre raison, selon la première éventualité.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Deux bras de l'étude seront traités en cycles de 4 semaines jusqu'à la progression de la maladie, les événements indésirables (EI) inacceptables, la demande du participant d'arrêter le traitement ou toute autre raison, selon la première éventualité.

Type d'étude

Interventionnel

Inscription (Réel)

531

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Participants atteints de myélome multiple ayant reçu au moins une ligne de traitement antérieure comprenant du lénalidomide et un inhibiteur du protéasome, et avec une protéine M sérique mesurable (≥ 0,5 g/dL) et/ou une protéine M urinaire (≥ 200 mg/24 heures) et/ou dosage des chaînes légères libres sériques (FLC) (dosage FLC impliqué ≥ 10 mg/dL et rapport FLC sérique anormal (1,65))

Critère d'exclusion:

  • Participants âgés de moins de 18 ans, participants ayant un statut de performance de l'Eastern Cooperative Oncology Group supérieur à 2
  • Participants au myélome multiple réfractaire primaire
  • Participants réfractaires aux anti-CD38 avec une période de sevrage inférieure à 9 mois ou intolérants aux agents anti-CD38 mAb
  • Traitement antérieur par pomalidomide
  • Participants avec des tests biologiques inadéquats.
  • Dysfonctionnement cardiaque important
  • Participants diagnostiqués ou traités pour un autre cancer dans les 3 ans précédant la randomisation, à l'exception de la résection complète d'un carcinome basocellulaire ou d'un carcinome épidermoïde de la peau, et d'une malignité in situ ou d'un cancer de la prostate à faible risque après traitement curatif
  • Leucémie à plasmocytes concomitante
  • Amylose primaire active à lumière amyloïde (AL)
  • Maladie connue liée au syndrome d'immunodéficience acquise (SIDA) ou maladie connue du virus de l'immunodéficience humaine (VIH) nécessitant un traitement antiviral
  • Connaître une infection active par l'hépatite A. Infection actuelle active ou chronique par l'hépatite B (VHB) ou l'hépatite C (VHC). Les participants atteints d'une maladie chronique du VHB ou du VHC contrôlée par un traitement antiviral sont autorisés.
  • Femmes en âge de procréer ou participant masculin avec des femmes en âge de procréer qui ne sont pas d'accord pour utiliser une méthode de contraception très efficace

Les informations ci-dessus ne sont pas destinées à contenir toutes les considérations relatives à la participation potentielle d'un participant à un essai clinique.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Isatuximab intraveineux (IV)
La dose d'isatuximab sera administrée par perfusion IV chaque semaine pendant 4 semaines pendant le cycle 1 (jours 1, 8, 15 et 22) et les jours 1 et 15 des cycles suivants. Chaque cycle durera 28 jours. La dose de pomalidomide sera prise par voie orale du jour 1 au jour 21 de chaque cycle à l'heure qui convient le mieux aux participants avant ou après l'administration d'isatuximab, de préférence à la même heure chaque jour. La dexaméthasone sera prise par voie orale les jours 1, 8, 15 et 22 (à répéter tous les 28 jours). Les participants peuvent recevoir d'autres traitements comme traitement de fond et/ou médicaments de secours.
Médicament: Dexaméthasone
Forme pharmaceutique : Comprimé ; Voie d'administration : orale
Médicament: Pomalidomide
Forme pharmaceutique : gélules ; Voie d'administration : orale
Autres noms:
  • Pomalyst ou équivalent
Médicament: Isatuximab IV
Forme pharmaceutique : Solution concentrée pour perfusion IV ; Voie d'administration : intraveineuse
Autres noms:
  • SAR650984
  • SARCLISA®
Médicament: Dexaméthasone
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : orale ; Médicament auxiliaire (AxMP), c'est-à-dire traitement de fond ; Code ATC : H02AB02
Médicament: Montélukast
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : orale ; AxMP, c'est-à-dire le traitement de fond ; Code ATC : R03DC03
Médicament: Paracétamol / Acétaminophène
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : orale ; AxMP, c'est-à-dire le traitement de fond ; Code ATC : N02BE01
Médicament: Diphénhydramine
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : En prémédication - orale ; pour la gestion des réactions à la perfusion-IV (ou équivalent oral) ; AxMP, c'est-à-dire traitement de fond et médicaments de secours (en cas de réactions à la perfusion) ; Code ATC : R06AA02
Médicament: Méthylprednisolone
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : En prémédication-IV ; pour la gestion des réactions à la perfusion - IV (ou équivalent oral) ; AxMP, c'est-à-dire traitement de fond et médicaments de secours (en cas de réactions à la perfusion) ; Code ATC : H02AB04
Expérimental: 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.
Médicament: Isatuximab SC
Forme pharmaceutique : Solution pour administration sous-cutanée ; Voie d'administration : Sous-cutanée (SC)
Autres noms:
  • SAR650984
Médicament: Dexaméthasone
Forme pharmaceutique : Comprimé ; Voie d'administration : orale
Médicament: Pomalidomide
Forme pharmaceutique : gélules ; Voie d'administration : orale
Autres noms:
  • Pomalyst ou équivalent
Médicament: Dexaméthasone
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : orale ; Médicament auxiliaire (AxMP), c'est-à-dire traitement de fond ; Code ATC : H02AB02
Médicament: Montélukast
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : orale ; AxMP, c'est-à-dire le traitement de fond ; Code ATC : R03DC03
Médicament: Paracétamol / Acétaminophène
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : orale ; AxMP, c'est-à-dire le traitement de fond ; Code ATC : N02BE01
Médicament: Diphénhydramine
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : En prémédication - orale ; pour la gestion des réactions à la perfusion-IV (ou équivalent oral) ; AxMP, c'est-à-dire traitement de fond et médicaments de secours (en cas de réactions à la perfusion) ; Code ATC : R06AA02
Médicament: Méthylprednisolone
Forme pharmaceutique : Selon le produit commercial local ; Voie d'administration : En prémédication-IV ; pour la gestion des réactions à la perfusion - IV (ou équivalent oral) ; AxMP, c'est-à-dire traitement de fond et médicaments de secours (en cas de réactions à la perfusion) ; Code ATC : H02AB04

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Taux de réponse global (TRG)
Délai: Dès la première dose du médicament de l'étude (Jour 1) jusqu'à la PCD (06-nov-2024), environ 28 mois
Taux de réponse objective (ORR) par comité d'évaluation indépendant (IRC) selon les critères 2016 du groupe de travail international sur le myélome (IMWG) : Pourcentage de participants avec réponse complète (CR), réponse complète stricte (sCR), très bonne réponse partielle (VGPR) et réponse partielle (PR). CR : immunofixation négative sur sérum et urine, disparition de tout plasmocytome des tissus mous (STP), <5 % de plasmocytes dans les aspirats de moelle osseuse (BM) et un ratio de chaînes légères libres (FLC) normal (0,26-1,65). sCR : CR plus aucune cellule clonale dans la biopsie de moelle osseuse. VGPR : protéine M sérique et urinaire détectable par immunofixation, pas par électrophorèse ; réduction ≥90 % de la protéine M sérique plus niveau de protéine M urinaire <100 mg/24 heures (h) ; diminution ≥90 % de la somme des diamètres perpendiculaires maximaux (SPD) par rapport à la ligne de base dans les STP ; FLC uniquement : diminution ≥90 % de la différence entre les niveaux de FLC impliqués et non impliqués. PR : réduction ≥50 % de la protéine M sérique et réduction de la protéine M urinaire de 24h par ≥90 % ou à <200 mg/24h. En plus de ce qui précède, si présents à la ligne de base, une réduction ≥50 % de la taille SPD des STP est également requise.
Dès la première dose du médicament de l'étude (Jour 1) jusqu'à la PCD (06-nov-2024), environ 28 mois
Concentration observée avant l'administration (Ctrough) de l'isatuximab à l'état d'équilibre
Délai: Pré-dose au Cycle 6 Jour 1
La Ctrough à l'état d'équilibre était la concentration plasmatique observée collectée avant la dose au Cycle 6 Jour 1 (équivalente à avant le Cycle 6 Jour 1) de l'administration de la dose d'isatuximab.
Pré-dose au Cycle 6 Jour 1

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Ctrough de l'Isatuximab à 4 semaines (CT4W)
Délai: Pré-dose au Cycle 2 Jour 1 (à 4 semaines)
Les concentrations plasmatiques observées CT4W ont été collectées avant l'administration de la dose d'isatuximab, à Cycle 2 Jour 1 (équivalent à avant Cycle 2 Jour 1).
Pré-dose au Cycle 2 Jour 1 (à 4 semaines)
Pourcentage de participants ayant répondu Très satisfait et Satisfait au 'Questionnaire sur l'expérience et la satisfaction du patient (PESQ-FU) : Satisfaction concernant la méthode d'injection' (Item-8) au Jour 15 du Cycle 5
Délai: Cycle 5 Jour 15
Le PESQ-FU, composé de 9 items, a été conçu pour suivre l'expérience et la satisfaction des participants concernant la méthode d'injection (inconfort, douleur, effets secondaires, gain de temps et satisfaction) et le médicament de l'étude (effets secondaires, valeur de prise, satisfaction et recommandation). Ce questionnaire a été adapté sur la base d'entretiens qualitatifs avec des participants en oncologie. Les réponses à la 'satisfaction concernant la méthode d'injection' ont été enregistrées comme 'très satisfait, satisfait, ni satisfait ni insatisfait, insatisfait et très insatisfait' à des moments spécifiques. Le pourcentage total de participants qui étaient très satisfaits et satisfaits de la méthode d'injection (item-8) au Jour 15 du Cycle 5 est rapporté ici. Les pourcentages sont arrondis à la dixième décimale.
Cycle 5 Jour 15
C_{trough} de l'Isatuximab
Délai: Pré-dose au cycle 1 jours 8, 15 et 22, cycles 2 à 5 jours 1 et 15, cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 et 27 jour 1
Les échantillons de plasma ont été prélevés à des moments spécifiques pour l'évaluation de la Ctrough.
Pré-dose au cycle 1 jours 8, 15 et 22, cycles 2 à 5 jours 1 et 15, cycles 6, 7, 8, 9, 12, 15, 18, 21, 24 et 27 jour 1
Pourcentage de participants ayant répondu au 'Questionnaire sur les attentes des patients au départ (PEQ-BL)'
Délai: Ligne de base (Cycle 1 Jour 1)
Le pourcentage de participants ayant répondu qu'ils sont tout à fait d'accord ou d'accord au départ avec les attentes concernant la douleur, l'inconfort et les effets secondaires de la méthode d'injection, que la méthode d'injection permettrait de gagner du temps, que le médicament de l'étude pourrait entraîner des effets secondaires et que cela vaudrait la peine de le prendre sont rapportés. Le PEQ-BL comprenait 7 items. Le pourcentage de participants ayant déjà reçu un médicament par administration IV et/ou SC est également rapporté. Les pourcentages sont arrondis à la dixième décimale. La valeur de base était définie comme la dernière valeur non manquante collectée à ou avant la date de début du médicament de l'étude.
Ligne de base (Cycle 1 Jour 1)
Questionnaire sur l'Utilisation des Ressources de Santé et la Productivité (HRUPQ) : Utilisation des Soins de Santé de Référence : Nombre de Fois au Cours des 6 Derniers Mois où un Participant a Reçu des Soins
Délai: Baseline (Cycle 1 Jour 1)
L'utilisation des soins de santé à l'inclusion avant l'administration du médicament de l'étude a été collectée via le HRUPQ. Le nombre moyen de fois au cours des 6 derniers mois où un participant a reçu des soins dans une clinique ou un service d'urgence hospitalier pour tout problème de santé incluant la MM ou dû à la MM, ainsi que des soins à domicile par un infirmier ou un autre professionnel de santé pour tout problème de santé incluant la MM ou dû à la MM est présenté. La valeur initiale était définie comme la dernière valeur non manquante collectée à ou avant la date de début du médicament de l'étude.
Baseline (Cycle 1 Jour 1)
HRUPQ : Utilisation des soins de santé au départ : Nombre de nuits passées à l'hôpital par un participant au cours des 6 derniers mois
Délai: Ligne de base (Cycle 1 Jour 1)
L'utilisation des soins de santé à la ligne de base avant l'administration du médicament de l'étude a été collectée via le HRUPQ. Le nombre moyen de nuits au cours des 6 derniers mois qu'un participant a passées à l'hôpital pour tout problème de santé incluant la MM ou dû à la MM et le nombre de nuits passées en unité de soins intensifs (USI) pour tout problème de santé incluant la MM ou dû à la MM sont présentés. La valeur de base était définie comme la dernière valeur non manquante collectée à la date de début du médicament de l'étude ou avant celle-ci.
Ligne de base (Cycle 1 Jour 1)
HRUPQ : Utilisation des soins de santé de base : Nombre de fois au cours des 6 derniers mois qu'un participant a consulté un professionnel de santé (HCP)
Délai: Ligne de base (Cycle 1 Jour 1)
L'utilisation des soins de santé au départ avant l'administration du médicament de l'étude a été recueillie via le HRUPQ. Le nombre moyen de fois au cours des 6 derniers mois où un participant a consulté (a vu ou parlé à) les professionnels de santé suivants : médecin généraliste ou clinicien de soins primaires (CSP) qui traite diverses maladies pour tout problème de santé incluant la MM ou lié à la MM, physiothérapeute ou ergothérapeute pour tout problème de santé incluant la MM ou lié à la MM, professionnel de santé mentale (par ex. psychiatre, psychologue, infirmier psychiatrique) pour tout problème de santé incluant la MM ou lié à la MM, médecin ou clinicien spécialisé dans une maladie ou problème médical particulier (spécialiste) pour tout problème de santé incluant la MM ou lié à la MM est présenté. La valeur de base a été définie comme la dernière valeur non manquante collectée à la date de début du médicament de l'étude ou avant.
Ligne de base (Cycle 1 Jour 1)
Pourcentage de participants ayant pris leur retraite au cours de l'étude basé sur le HRUPQ
Délai: De la première dose du médicament de l'étude (Jour 1) jusqu'au PCD (06-nov-2024), environ 28 mois
Le statut d'emploi a été évalué via le HRUPQ. Le pourcentage de participants ayant pris leur retraite au cours de l'étude est indiqué. Les pourcentages sont arrondis à la dixième décimale.
De la première dose du médicament de l'étude (Jour 1) jusqu'au PCD (06-nov-2024), environ 28 mois
Pourcentage de participants ayant pris une retraite anticipée en raison du MM basé sur le HRUPQ
Délai: De la première dose de l'administration du médicament de l'étude (Jour 1) jusqu'à la PCD (06-nov-2024), environ 28 mois
Le statut d'emploi a été évalué via le HRUPQ. Le pourcentage de participants ayant pris une retraite anticipée en raison du MM est rapporté. Les pourcentages sont arrondis à la décimale près.
De la première dose de l'administration du médicament de l'étude (Jour 1) jusqu'à la PCD (06-nov-2024), environ 28 mois
Very Good Partial Response or Better Rate
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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'
Délai: 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)'
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

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Parrainer

Sanofi

Les enquêteurs

  • Directeur d'études: Clinical Sciences & Operations, Sanofi

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 juin 2022

Achèvement primaire (Réel)

6 novembre 2024

Achèvement de l'étude (Estimé)

22 octobre 2027

Dates d'inscription aux études

Première soumission

31 mai 2022

Première soumission répondant aux critères de contrôle qualité

31 mai 2022

Première publication (Réel)

6 juin 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • EFC15951
  • 2023 (Subvention/contrat des NIH des États-Unis: GRAMMY Museum Foundation)
  • U1111-1261-5846 (Identificateur de registre: ICTRP)
  • 2023-508869-32 (Numéro EudraCT: CTIS)

Plan pour les données individuelles des participants (IPD)

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OUI

Description du régime IPD

Les chercheurs qualifiés peuvent demander l'accès aux données au niveau du patient et aux documents d'étude connexes, y compris le rapport d'étude clinique, le protocole d'étude avec toutes les modifications, le formulaire de rapport de cas vierge, le plan d'analyse statistique et les spécifications de l'ensemble de données. Les données au niveau des patients seront anonymisées et les documents de l'étude seront expurgés pour protéger la vie privée des participants à l'essai. De plus amples détails sur les critères de partage des données de Sanofi, les études éligibles et le processus de demande d'accès sont disponibles sur : https://vivli.org.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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