Evidence map›Paper›PMID 34647444›Full record

Trial reportHaematologica2022

Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis.

Marcelo Capra, Thomas Martin, Philippe Moreau, Ross Baker, Ludek Pour, Chang-Ki Min, Xavier Leleu, Mohamad Mohty, Marta Reinoso Segura, Mehmet Turgut and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Haematologica, 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 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.4field-weighted citation impact, top 7% 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

20 citing papers in PubMed, 29 citations in OpenAlex.

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  5. Observational
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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

15 authors at 12 institutions in 10 countries.

Marcelo CapraCentro Integrado de Hematologia e Oncologia, Hospital Mãe de Deus, Porto Alegre. marcelocapra@hotmail.com.
Thomas MartinDepartment of Medicine, University of California at San Francisco, San Francisco, CA.
Philippe MoreauDepartment of Hematology, University of Nantes, Nantes.
Ross BakerPerth Blood Institute, Murdoch University, Perth.
Ludek PourDepartment of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.
Chang-Ki MinDepartment of Hematology, Catholic Hematology Hospital and Leukemia Research Institute, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.
Xavier LeleuService d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex.
Mohamad MohtyDepartment of Hematology, Hôpital Saint-Antoine, Sorbonne University, INSERM UMRs 938, Paris.
Marta Reinoso SeguraHospital Universitario Virgen del Rocio, Sevilla.
Mehmet TurgutDepartment of Hematology, Ondokuz Mayıs University Faculty of Medicine, Samsun.
Richard LeBlancHôpital Maisonneuve-Rosemont, Université de Montréal.
Marie-Laure RisseSanofi Research and Development, Vitry/Alfortville.
Laure MalingeAixial, Boulogne-Billancourt.
Sandrine SchwabSanofi Research and Development, Vitry/Alfortville.
Meletios DimopoulosDepartment of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens.
Inserm · FRSanofi (France) · FRHôpital Maisonneuve-Rosemont · CAHospital Mãe de Deus · BRHospital Universitario Virgen del Rocío · ESMurdoch University · AUNantes Université · FRNational and Kapodistrian University of Athens · GROndokuz Mayıs University · TRThe Catholic University of Korea Seoul St. Mary's Hospital · KRUniversity Hospital Brno · CZUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) versus Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate <60 mL/min/1.73 m². Addition of Isa prolonged progression-free survival (PFS) in patients with RI (hazard ratio: 0.27; 95% confidence interval [CI]: 0.11-0.66; median PFS not reached for Isa-Kd versus 13.4 months for Kd [20.8-month follow-up]). Complete renal responses occurred more frequently with Isa-Kd (52.0%) versus Kd (30.8%) and were durable in 32.0% versus 7.7% of patients, respectively. Treatment exposure was longer with Isa-Kd, with median number of started cycles and median duration of exposure of 20 versus 9 cycles and 81.0 versus 35.7 weeks for Isa-Kd versus Kd, respectively. Among patients with RI, the incidence of patients with grade ≥3 treatment-emergent adverse events was similar between the two arms (79.1% in Isa-Kd vs. 77.8% in Kd). In summary, the addition of Isa to Kd improved clinical outcomes with a manageable safety profile in patients with RI, consistent with the benefit observed in the overall IKEMA study population.

Indexed as

Multiple MyelomaRenal InsufficiencyAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneHumansOligopeptidesAntibodies, Monoclonal, HumanizedcarfilzomibDexamethasoneisatuximabOligopeptides

Identifiers

PMID34647444
PMCPMC9152981
OpenAlexW3207809849

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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.