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Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma in real-world: The retrospective IMAGE study.
Decaux, Olivier; Fontan, Jean; Perrot, Aurore; Karlin, Lionel; Touzeau, Cyrille; Schulmann, Samantha; Manier, Salomon; Belhadj, Karim; Trebouet, Adrien; Zunic, Patricia; Schiano De Colella, Jean-Marc; Castel, Brice; Van De Wyngaert, Zoé; Pica, Gian Matteo; Tiab, Mourad; Kuhnowski, Frédérique; Bouketouche, Malek; Rigaudeau, Sophia; Benramdane, Riad; Tekle, Christina; Lafore, Radhia; Gaucher, Marianne; Corre, Jill; Leleu, Xavier.
Affiliation
  • Decaux O; INSERM, Établissement Français du Sang de Bretagne, Unité Mixte de Recherche (UMR) S1236, Université de Rennes 1, Rennes, France.
  • Fontan J; Service d'Hématologie Clinique, Centre Hospitalier Universitaire, Rennes, France.
  • Perrot A; Department of Hematology, Centre Hospitalier Régional et Universitaire de Besançon, Besançon, France.
  • Karlin L; CHU de Toulouse, IUCT-O, Service d'Hématologie, UPS, Université de Toulouse, Toulouse, France.
  • Touzeau C; Hematology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, France.
  • Schulmann S; Department of Hematology, University Hospital of Nantes, Nantes, France.
  • Manier S; Hématologie, CHRU Hôpitaux de Brabois, Nancy, France.
  • Belhadj K; Maladie du sang, CHRU Hôpital Claude Huriez, Lille, France.
  • Trebouet A; Unité Hémopathies Lymphoïdes, Centre Hospitalier Universitaire Henri Mondor, Créteil, France.
  • Zunic P; Department of Haematology, Bretagne Sud Hospital Centre, Lorient, France.
  • Schiano De Colella JM; Department of Haematology, University Hospital Centre, Saint-Pierre, France.
  • Castel B; Department of Hematology, Institut Paoli Calmettes, Marseille, France.
  • Van De Wyngaert Z; Service de Médecine Interne, Centre Hospitalier de Bigorre, Tarbes, France.
  • Pica GM; Sorbonne Université, AP-HP, Centre de Recherche Saint-Antoine INSERM UMRs938, Service D'Hématologie Clinique et de Thérapie Cellulaire, Hôpital Saint Antoine, AP-HP, Paris, France.
  • Tiab M; Hématologie, Centre Hospitalier Métropole Savoie, Chambéry, France.
  • Kuhnowski F; Médecine Interne, CHU Vendée, La Roche sur Yon, France.
  • Bouketouche M; Department of Hematology, Institut Curie, Paris, France.
  • Rigaudeau S; Oncologie et hématologie, Centre Hospitalier de Saint-Quentin, Saint-Quentin, France.
  • Benramdane R; Service d'Hématologie Clinique, Centre Hospitalier de Versailles André Mignot, Faculté de Médecine Xavier Bichat, Université Paris Diderot, Paris, France.
  • Tekle C; Department of Hematology, Centre Hospitalier Pontoise René Dubos, Pontoise, France.
  • Lafore R; Sanofi, Cambridge, Massachusetts, USA.
  • Gaucher M; Sanofi, Gentilly, France.
  • Corre J; Sanofi, Gentilly, France.
  • Leleu X; IUC-T Oncopole, Unité de Génomique du Myélome, Toulouse, France.
Eur J Haematol ; 113(3): 290-297, 2024 Sep.
Article in En | MEDLINE | ID: mdl-38712850
ABSTRACT

BACKGROUND:

IMAGE is a retrospective cohort study of patients enrolled in early access programs (EAPs) in France with relapsed/refractory multiple myeloma (RRMM) receiving isatuximab with pomalidomide and dexamethasone (Isa-Pd).

METHODS:

Patients aged ≥18 years with RRMM who received ≥1 dose of Isa under the EAPs between July 29, 2019 and August 30, 2020 were included. Effectiveness endpoints included progression-free survival (PFS) and response rates. Verbatim terms for adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities and not graded for severity.

RESULTS:

A total of 294 and 299 patients were included in the effectiveness and safety populations, respectively. IMAGE included patients who received one prior line of treatment (10.2%) and were daratumumab-refractory (19.1%). At median follow-up of 14.2 months, median PFS in the effectiveness population was 12.4 months (95% CI 9.0-15.0). Overall response and very good partial response rates were 46.3% and 27.9%, respectively. Subgroup analyses reflected similar results. In the safety population, 26.4% of patients reported at least one AE; the most common any-grade AE was neutropenia (9.4%).

CONCLUSION:

IMAGE demonstrated Isa-Pd had meaningful effectiveness in median PFS and depth of response and no new safety signals in a real-world context, consistent with clinical trial results.
Subject(s)
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Thalidomide / Dexamethasone / Antineoplastic Combined Chemotherapy Protocols / Antibodies, Monoclonal, Humanized / Multiple Myeloma Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: Eur J Haematol Journal subject: HEMATOLOGIA Year: 2024 Document type: Article Affiliation country: Francia Country of publication: Reino Unido

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Thalidomide / Dexamethasone / Antineoplastic Combined Chemotherapy Protocols / Antibodies, Monoclonal, Humanized / Multiple Myeloma Limits: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Language: En Journal: Eur J Haematol Journal subject: HEMATOLOGIA Year: 2024 Document type: Article Affiliation country: Francia Country of publication: Reino Unido