Evidence map›Paper›PMID 32444867›Full record

Trial reportLeukemia2021

Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis.

Meletios A Dimopoulos, Xavier Leleu, Philippe Moreau, Paul G Richardson, Anna Marina Liberati, Simon J Harrison, H Miles Prince, Enrique M Ocio, Sylvie Assadourian, Frank Campana and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Leukemia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
6.7field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 72 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Partnering With All Patients: Ensuring Shared Decision Making and Evidence-Based Management for Underrepresented Groups With Multiple Myeloma.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2023
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Anti CD38 monoclonal antibodies for multiple myeloma treatment.Human vaccines & immunotherapeutics · 2022
    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

14 authors at 11 institutions in 7 countries.

Meletios A DimopoulosDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece. mdimop@med.uoa.gr.
Xavier LeleuDepartment of Hematology, Centre Hospitalier Universitaire, Université de Poitiers, Poitiers, France.
Philippe MoreauUniversity of Nantes, Nantes, France.
Paul G RichardsonMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Anna Marina LiberatiOncology-Hematology, Santa Maria Hospital, University of Perugia, Terni, Italy.
Simon J HarrisonClinical Haematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital; Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, VIC, Australia.
H Miles PrinceEpworth Healthcare, University of Melbourne, Melbourne, VIC, Australia.
Enrique M OcioHospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain.
Sylvie AssadourianSanofi R&D, Paris, France.
Frank CampanaSanofi-Genzyme Oncology, Cambridge, MA, USA.
Laure MalingeAixial (for Sanofi), Boulogne-Billancourt, France.
Dorothée SémiondSanofi R&D, Paris, France.
Helgi van de VeldeSanofi-Genzyme Oncology, Cambridge, MA, USA.
Kwee YongDepartment of Haematology, University College London Hospitals NHS Foundation Trust, London, UK.
Sanofi (France) · FRAVEO Oncology (United States) · USCentre Hospitalier Universitaire de Poitiers · FRDana-Farber Cancer Institute · USInstituto de Investigación Marqués de Valdecilla · ESNantes Université · FRNational and Kapodistrian University of Athens · GRThe Royal Melbourne Hospital · AUUniversity College London · GBUniversity of Melbourne · AUUniversity of Perugia · IT

Funding

Sanofi N/A
6 · The paper itself

Abstract

The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines. This prespecified subgroup analysis examined efficacy in patients with renal impairment (RI; estimated glomerular filtration rate <60 mL/min/1.73 m²). Isa 10 mg/kg was given intravenously once weekly in cycle 1, and every 2 weeks in subsequent 28-day cycles. Patients received standard doses of Pd. Median progression-free survival (PFS) for patients with RI was 9.5 months with Isa-Pd (n = 55) and 3.7 months with Pd (n = 49; hazard ratio [HR] 0.50; 95% confidence interval [CI], 0.30-0.85). Without RI, median PFS was 12.7 months with Isa-Pd (n = 87) and 7.9 months with Pd (n = 96; HR 0.58; 95% CI, 0.38-0.88). The overall response rate (ORR) with and without RI was higher with Isa-Pd (56 and 68%) than Pd (25 and 43%). Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ≥60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively. Isa pharmacokinetics were comparable between the subgroups, suggesting no need for dose adjustment in patients with RI. In summary, the addition of Isa to Pd improved PFS, ORR and renal response rates.

Indexed as

Drug Resistance, NeoplasmSalvage TherapyAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleFollow-Up StudiesHumansMaleMiddle AgedMultiple MyelomaNeoplasm Recurrence, LocalPrognosisAntibodies, Monoclonal, HumanizedDexamethasoneisatuximabpomalidomideThalidomide

Identifiers

PMID32444867
PMCPMC7862055
OpenAlexW3027520213

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.