Evidence map›Paper›PMID 38299578›Full record

Trial reportHaematologica2024

Isatuximab-pomalidomide-dexamethasone

Paul G Richardson, Aurore Perrot, Jesus San Miguel, Meral Beksac, Ivan Spicka, Xavier Leleu, Fredrik Schjesvold, Philippe Moreau, Meletios A Dimopoulos, Shang-Yi Huang and 8 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Haematologica, 2024. 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 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 5% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Review
  8. Review
  9. Article
  10. Multiple Myeloma Unpacked.Hematological oncology · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Monoclonal Antibodies in Relapsed-Refractory Multiple Myeloma.Pharmaceuticals (Basel, Switzerland) · 2025
    Review
  16. Article
  17. An Update of the Appropriate Sequencing for Salvage Therapies in Multiple Myeloma.Mediterranean journal of hematology and infectious diseases · 2025
    Review
  18. Article
  19. Article
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 13 institutions in 9 countries.

Paul G RichardsonJerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA. paul_richardson@dfci.harvard.edu.
Aurore PerrotCHU de Toulouse, IUCT-O, Université de Toulouse, UPS, Service d'Hématologie, Toulouse.
Jesus San MiguelClínica Universidad de Navarra, Navarra, CCUN, CIMA, IDISNA, CIBER-ONC, Pamplona.
Meral BeksacDepartment of Hematology, Ankara University, Ankara, Turkey.
Ivan SpickaGeneral Faculty Hospital, Prague, Czech Republic; First Faculty of Medicine, Charles University, Prague, Czech Republic.
Xavier LeleuService d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex.
Fredrik SchjesvoldOslo Myeloma Center, Department of Haematology, Oslo University Hospital, Oslo, Norway; KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.
Philippe MoreauHematology Department, CHU Nantes, Nantes.
Meletios A DimopoulosDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.
Shang-Yi HuangDepartment of Hematology, National Taiwan University Hospital, Taipei, Taiwan.
Jiri MinarikDepartment of Hemato-Oncology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Olomouc, Czech Republic.
Michele CavoIRCCS Azienda Ospedaliero-Universitaria di Bologna, Seràgnoli Institute of Hematology, and the Department of Medical and Surgical Sciences, Bologna University School of Medicine, Bologna, Italy.
H Miles PrinceImmunology and Molecular Oncology, Epworth Healthcare, University of Melbourne, Melbourne, VIC, Australia.
Sandrine MacéSanofi, Vitry-sur-Seine.
Rick ZhangSanofi, Cambridge, MA.
Franck DubinSanofi, Vitry-sur-Seine.
Mony Chenda MorisseSanofi, Cambridge, MA.
Kenneth C AndersonJerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana Farber Cancer Institute, Harvard Medical School, Boston, MA.
Harvard University · USSanofi (France) · FRSanofi (United States) · USAnkara University · TRCentre Hospitalier Universitaire de Toulouse · FRClinica Universidad de Navarra · ESEpworth Hospital · AUGeneral University Hospital in Prague · CZInserm · FRNational and Kapodistrian University of Athens · GRNational Taiwan University Hospital · TWOslo University Hospital · NOPalacký University Olomouc · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary and prespecified updated analyses of ICARIA-MM (clinicaltrial gov. Identifier: NCT02990338) demonstrated improved progression-free survival (PFS) and a benefit in overall survival (OS) was reported with the addition of isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide-dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma. Here, we report the final OS analysis. This multicenter, randomized, open-label, phase III study included patients who had received and failed ≥2 previous therapies, including lenalidomide and a proteasome inhibitor. Between January 10, 2017, and February 2, 2018, 307 patients were randomized (1:1) to isatuximab-pomalidomide-dexamethasone (Isa-Pd; N=154) or Pd (N=153), stratified based on age (<75 vs. ≥75 years) and number of previous lines of therapy (2-3 vs. >3). At data cutoff for the final OS analysis after 220 OS events (January 27, 2022), median follow-up duration was 52.4 months. Median OS was 24.6 months (95% confidence interval [CI]: 20.3-31.3) with Isa-Pd and 17.7 months (95% CI: 14.4- 26.2) with Pd (hazard ratio=0.78; 95% CI: 0.59-1.02; 1-sided P=0.0319). Despite subsequent daratumumab use in the Pd group and its potential benefit on PFS in the first subsequent therapy line, median PFS2 was significantly longer with Isa-Pd versus Pd (17.5 vs. 12.9 months; log-rank 1-sided P=0.0091). In this analysis, Isa-Pd continued to be efficacious and well tolerated after follow-up of approximately 52 months, contributing to a clinically meaningful, 6.9-month improvement in median OS in patients with relapsed/refractory multiple myeloma.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneMultiple MyelomaThalidomideAdultAgedAged, 80 and overDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedRecurrenceSurvival AnalysisTreatment OutcomeAntibodies, Monoclonal, HumanizedDexamethasoneisatuximabpomalidomideThalidomide

Identifiers

PMID38299578
PMCPMC11215383
OpenAlexW4391437985

What OpenQuestion holds

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LicenceCC BY-NC
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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.