Evidence map›Paper›PMID 37156782›Full record

Trial reportBlood cancer journal2023

Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study.

Thomas Martin, Meletios-Athanasios Dimopoulos, Joseph Mikhael, Kwee Yong, Marcelo Capra, Thierry Facon, Roman Hajek, Ivan Špička, Ross Baker, Kihyun Kim and 11 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Blood cancer journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 64 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 5 pooled it
25.9field-weighted citation impact, top 1% 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

64 citing papers in PubMed, 5 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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  12. NADAlzheimer's & dementia : the journal of the Alzheimer's Association · 2026
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 18 institutions in 10 countries.

Thomas Martin *Department of Hematology, University of California at San Francisco, San Francisco, CA, USA. Tom.Martin@ucsf.edu.ORCID http://orcid.org/0000-0002-9133-9813
Meletios-Athanasios DimopoulosThe National and Kapodistrian University of Athens, Athens, Greece.ORCID http://orcid.org/0000-0001-8990-3254
Joseph MikhaelTranslational Genomics Research Institute, City of Hope Cancer Center, Phoenix, AZ, USA.ORCID http://orcid.org/0000-0001-9670-2864
Kwee YongDepartment of Haematology, University College Hospital, London, UK.ORCID http://orcid.org/0000-0002-6487-276X
Marcelo CapraCentro Integrado de Hematologia e Oncologia, Hospital Mãe de Deus, Porto Alegre, Brazil.
Thierry FaconDepartment of Haematology, Lille University Hospital, Lille, France.
Roman HajekDepartment of Hemato-Oncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.ORCID http://orcid.org/0000-0001-6955-6267
Ivan ŠpičkaDepartment of Hematology, 1st Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic.
Ross BakerPerth Blood Institute, Murdoch University, Perth, Australia.
Kihyun KimDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Gracia MartinezHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Chang-Ki MinDepartment of Hematology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Ludek PourDepartment of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.
Xavier LeleuService d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm, 1402, Poitiers Cedex, France.ORCID http://orcid.org/0000-0002-9822-4170
Albert OriolInstitut Josep Carreras and Institut Catala d'Oncologia, Hospital Germans Trias I Pujol, Badalona, Spain.ORCID http://orcid.org/0000-0001-6804-2221
Youngil KohDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Kenshi SuzukiMyeloma/Amyloidosis Center, Japanese Red Cross Medical Center, Tokyo, Japan.
France CascaIvidata Life Science, Levallois-Perret, France.
Sandrine MacéSanofi, R&D, Chilly-Mazarin, France.
Marie-Laure RisseSanofi, R&D, Vitry-sur-Seine, France.
Philippe Moreau *Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.
Sanofi (France) · FRCharles University · CZHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRHospital Mãe de Deus · BRInserm · FRInstitut Català d'Oncologia · ESJapanese Red Cross Medical Center · JPLille’s Cardiology Hospital · FRMurdoch University · AUNational and Kapodistrian University of Athens · GRSamsung Medical Center · KRSeoul National University Hospital · KRThe Catholic University of Korea Seoul St. Mary's Hospital · KRTranslational Genomics Research Institute · USUniversity College Hospital · GBUniversity Hospital Brno · CZUniversity of California, San Francisco · USUniversity of Ostrava · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. Enrolled patients had relapsed/refractory multiple myeloma (1-3 prior treatment lines). Isa 10 mg/kg was administered intravenously weekly in cycle 1 then biweekly. Efficacy analyses were performed in the intent-to-treat population (Isa-Kd: n = 179, Kd: n = 123) and safety evaluated in treated patients (Isa-Kd: n = 177, Kd: n = 122). Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42-0.79; median PFS 35.7 [95% CI: 25.8-44.0] vs 19.2 [95% CI: 15.8-25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis. The stringent CR/CR rate was 44.1% vs 28.5% (odds-ratio: 2.09, 95% CI: 1.26-3.48), the MRD negativity rate 33.5% vs 15.4% (odds-ratio: 2.78, 95% CI: 1.55-4.99) and the MRD negativity CR rate 26.3% vs 12.2%, with Isa-Kd vs Kd. The safety profile of Isa-Kd was similar to that reported in the prior interim analysis. These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients.Clinical trial information: ClinicalTrials.gov, NCT03275285.

Indexed as

Multiple MyelomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneHumansOligopeptidesAntibodies, Monoclonal, HumanizedcarfilzomibDexamethasoneisatuximabOligopeptides

Identifiers

PMID37156782
PMCPMC10166682
OpenAlexW4375945603

What OpenQuestion holds

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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.