Evidence map›Paper›PMID 35871357›Full record

ArticleEuropean journal of haematology2022

Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics: IKEMA subgroup analysis.

Ivan Spicka, Philippe Moreau, Thomas G Martin, Thierry Facon, Gracia Martinez, Albert Oriol, Youngil Koh, Andrew Lim, Gabor Mikala, Laura Rosiñol and 7 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in European journal of haematology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03275285 (Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.4field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03275285 phase3completednot on this map

Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

TypeinterventionalSponsorSanofiRan2017 to 2025Enrolled302ConditionsPlasma Cell MyelomaArmsisatuximab SAR650984, carfilzomib, dexamethasone
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 24 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Observational
  7. The numerous facets of 1q21Oncology letters · 2024
    Review
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 15 institutions in 11 countries.

Ivan Spicka1st Department of Medicine-Department of Hematology, First Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic.
Philippe MoreauUniversity of Nantes, Nantes, France.ORCID https://orcid.org/0000-0003-1780-8746
Thomas G MartinUniversity of California San Francisco, San Francisco, California, USA.
Thierry FaconDepartment of Haematology, Lille University Hospital, Lille, France.
Gracia MartinezHospital das Clínicas de Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Albert OriolHematology Department, Institut Català d'Oncologia and Josep Carreras Institute, Hospital Germans Trias i Pujol, Badalona, Spain.ORCID https://orcid.org/0000-0001-6804-2221
Youngil KohSeoul National University Hospital, Seoul, South Korea.
Andrew LimAustin and Repatriation Medical Center, Heidelberg, Victoria, Australia.
Gabor MikalaDepartment of Hematology and Stem Cell Transplantation, National Institute for Hematology and Infectious Diseases, South Pest Central Hospital, Budapest, Hungary.
Laura RosiñolHospital Clinic, IDIBAPS, Barcelona, Spain.
Münci YağciGazi University, Ankara, Turkey.
Michele CavoIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Marie-Laure RisseSanofi, R&D, Vitry-Sur-Seine, France.
Gaëlle AssetSanofi, R&D, Chilly-Mazarin, France.
Sandrine MacéSanofi, R&D, Vitry-Sur-Seine, France.
Helgi van de VeldeSanofi, Cambridge, Massachusetts, USA.
Kwee YongDepartment of Haematology, University College Hospital, London, UK.
Sanofi (France) · FRCharles University · CZGazi University · TRHeidelberg Repatriation Hospital · AUHospital Clínic de Barcelona · ESHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRInstitut Català d'Oncologia · ESIstituto di Ematologia di Bologna · ITNantes Université · FRNational Center for Epidemiology · HUSanofi (United States) · USSeoul National University Hospital · KRUniversité de Lille · FRUniversity College Hospital · GBUniversity of California, San Francisco · US

Funding

Sanofi
6 · The paper itself

Abstract

introductionThe presence of high-risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). A prespecified interim analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib (K) and dexamethasone (d; Isa-Kd) significantly improved progression-free survival (PFS) versus Kd in patients with relapsed MM. This prespecified subgroup analysis of IKEMA examined efficacy and safety in patients with high-risk cytogenetics.

methodsHigh-risk cytogenetics was assessed by central laboratory and patients were classified as high risk if abnormalities were present in ≥1 of the following: del(17p): 50% cutoff; t(4;14), and/or t(14;16): 30% cutoff.

resultsOf the randomized patients, 23.5% (Isa-Kd) and 25.2% (Kd) had ≥1 high-risk chromosomal abnormality. A PFS benefit was seen in favor of Isa-Kd for patients with standard-risk (HR 0.440; 95% CI 0.266-0.728) and high-risk cytogenetics (HR 0.724; 95% CI 0.361-1.451). Grade ≥3 treatment-emergent adverse events (TEAEs) were more common with Isa-Kd (85.7%) versus Kd (63.3%) in patients with high-risk cytogenetics; however, the incidence of serious TEAEs (64.3% vs. 66.7%) was similar.

conclusionsIsa-Kd is a new treatment option for the difficult-to-treat subgroup of patients with relapsed MM and high-risk cytogenetics.

Indexed as

Multiple MyelomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneHumansOligopeptidesAntibodies, Monoclonal, HumanizedcarfilzomibDexamethasoneisatuximabOligopeptideshigh-risk cytogeneticsisatuximabmultiple myeloma

Identifiers

PMID35871357
PMCPMC9804737
OpenAlexW4286809396

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.