Evidence map›Paper›PMID 34036560›Full record

ArticleBritish journal of haematology2021

Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics.

Simon J Harrison, Aurore Perrot, Adrian Alegre, David Simpson, Ming Chung Wang, Andrew Spencer, Sosana Delimpasi, Cyrille Hulin, Kazutaka Sunami, Thierry Facon and 8 more

Registry-linked trialOpen access · hybridAbstract readComparative Study
In one paragraph

Article in British journal of haematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02990338 (A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab), which is not on this map. Cited by 33 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 4% 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.

NCT02990338 phase3completednot on this map

A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

TypeinterventionalSponsorSanofiRan2016 to 2023Enrolled307ConditionsPlasma Cell MyelomaArmsIsatuximab, Pomalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

  1. Co-Occurrence of Cytogenetic Abnormalities and High-Risk Disease in Newly Diagnosed and Relapsed/Refractory Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  13. Article
  14. The numerous facets of 1q21Oncology letters · 2024
    Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

18 authors at 15 institutions in 10 countries.

Simon J HarrisonPeter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, Victoria, Australia.ORCID 0000-0003-4555-6582
Aurore PerrotCentre Hospitalo-universitaire (CHU) de Toulouse, Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-O), Université de Toulouse, UPS, Service d'Hématologie, Toulouse, France.ORCID 0000-0003-0131-8689
Adrian AlegreUniversity Hospital La Princesa and University Hospital Quironsalud, Madrid, Spain.
David SimpsonNorth Shore Hospital, Auckland, New Zealand.
Ming Chung WangChang Gung Medical Foundation, Taipei, Taiwan.
Andrew SpencerThe Alfred Hospital, MONASH University/Australian Centre for Blood Diseases, Melbourne, Victoria, Australia.
Sosana DelimpasiEvangelismos Hospital, Athens, Greece.
Cyrille HulinService d'Hématologie Hôpital Haut-Lévêque CHU, Bordeaux, France.
Kazutaka SunamiDepartment of Hematology, National Hospital Organization Okayama Medical Center, Okayama, Japan.
Thierry FaconDepartment of Haematology, Lille University Hospital, Lille, France.
Philip VlummensDepartment of Haematology, Ghent University Hospital, Ghent, Belgium.
Kwee YongDepartment of Haematology, University College Hospital, London, UK.ORCID 0000-0002-6487-276X
Frank CampanaSanofi, Cambridge, MA, USA.
Marlène InchauspéIT&M Stats (for Sanofi), Neuilly-sur-Seine, Île-de-France, France.
Sandrine MacéSanofi R&D, Vitry-sur-Seine, France.
Marie-Laure RisseSanofi R&D, Vitry-sur-Seine, France.
Helgi van de VeldeSanofi, Cambridge, MA, USA.
Paul RichardsonMedical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.ORCID 0000-0002-7426-8865
Sanofi (France) · FRSanofi (United States) · USChang Gung University of Science and Technology · TWEvangelismos Hospital · GRGhent University Hospital · BEHarvard University · USHôpital Cardiologique du Haut-Lévêque · FRHospital Universitario Quirónsalud Madrid · ESLille’s Cardiology Hospital · FRNational Hospital Organization · JPNorth Shore Hospital · NZThe Alfred Hospital · AUThe Royal Melbourne Hospital · AUUniversité Toulouse III - Paul Sabatier · FRUniversity College Hospital · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Treatment benefit in multiple myeloma (MM) patients with high-risk cytogenetics remains suboptimal. The phase 3 ICARIA-MM trial (NCT02990338) showed that isatuximab plus pomalidomide-dexamethasone prolongs median progression-free survival (mPFS) in patients with relapsed/refractory MM (RRMM). This subgroup analysis of ICARIA-MM compared the benefit of isatuximab in high-risk [defined by the presence of del(17p), t(4;14) or t(14;16)] versus standard-risk patients. The efficacy of isatuximab in patients with gain(1q21) abnormality was also assessed in a retrospective subgroup analysis. In ICARIA-MM, 307 patients received isatuximab-pomalidomide-dexamethasone (n = 154) or pomalidomide-dexamethasone (n = 153). Isatuximab (10 mg/kg intravenously) was given weekly in the first 28-day cycle, and every other week thereafter. Standard pomalidomide-dexamethasone doses were given. Isatuximab-pomalidomide-dexamethasone improved mPFS (7·5 vs 3·7 months; HR, 0·66; 95% CI, 0·33-1·28) and overall response rate (ORR, 50·0% vs 16·7%) in high-risk patients. In patients with isolated gain(1q21), isatuximab addition improved mPFS (11·2 vs 4·6 months; HR, 0·50; 95% CI, 0·28-0·88) and ORR (53·6% vs 27·6%). More grade ≥3 adverse events occurred in high-risk patients receiving isatuximab (95·7%) versus the control group (67·6%); however, isatuximab did not increase events leading to discontinuation or treatment-related mortality. Isatuximab-pomalidomide-dexamethasone provides a consistent benefit over pomalidomide-dexamethasone treatment in RRMM patients regardless of cytogenetic risk.

Indexed as

Salvage TherapyAbnormal KaryotypeAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalChromosomes, Human, Pair 1Clinical Trials, Phase III as TopicDexamethasoneFebrile NeutropeniaFemaleHumansImmunologic FactorsKaplan-Meier EstimateMaleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalDexamethasoneImmunologic FactorsisatuximabMyeloma ProteinspomalidomideThalidomidecytogeneticsgain (1q21)high-riskisatuximabrelapsed/refractory multiple myeloma

Identifiers

PMID34036560
PMCPMC8361732
OpenAlexW3164479637

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.