Evidence map›Paper›PMID 37680948›Full record

ArticleEClinicalMedicine2023

Ixazomib, daratumumab and low-dose dexamethasone in intermediate-fit patients with newly diagnosed multiple myeloma: an open-label phase 2 trial.

Kaz Groen, Claudia A M Stege, Kazem Nasserinejad, Koen de Heer, Roel J W van Kampen, Rineke B L Leys, Noortje Thielen, Matthijs Westerman, Ka-Lung Wu, Inge Ludwig and 19 more

Open access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.1field-weighted citation impact, top 6% 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

9 citing papers in PubMed, 14 citations in OpenAlex.

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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

29 authors at 20 institutions in 4 countries.

Kaz GroenDepartment of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands.
Claudia A M StegeDepartment of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands.
Kazem NasserinejadHOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Koen de HeerDepartment of Internal Medicine, Flevoziekenhuis, Almere, the Netherlands.
Roel J W van KampenDepartment of Internal Medicine, Zuyderland Hospital, Sittard-Geleen, the Netherlands.
Rineke B L LeysDepartment of Internal Medicine, Maasstad Hospital, Rotterdam, the Netherlands.
Noortje ThielenDepartment of Internal Medicine, Diakonessenhuis, Utrecht, the Netherlands.
Matthijs WestermanDepartment of Internal Medicine, Northwest Clinics, Alkmaar, the Netherlands.
Ka-Lung WuDepartment of Hematology, ZNA Stuivenberg, Antwerpen, Belgium.
Inge LudwigDepartment of Internal Medicine, Ziekenhuis Bernhoven, Uden, the Netherlands.
Djamila E IssaDepartment of Internal Medicine, Jeroen Bosch Hospital, Den Bosch, the Netherlands.
Gerjo A VeldersDepartment of Internal Medicine, Gelderse Vallei, Ede, the Netherlands.
Marie-Christiane VekemansDepartment of Hematology, Cliniques Universitaires Saint-Luc, UCL, Brussels, Belgium.
Gert-Jan TimmersDepartment of Internal Medicine, Amstelland Hospital, Amstelveen, the Netherlands.
Fransien de BoerDepartment of Internal Medicine, Ikazia Hospital, Rotterdam, the Netherlands.
Lidwine W TickDepartment of Internal Medicine, Maxima Medical Center, Eindhoven, the Netherlands.
Annelies VerbruggeHOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Danny BuitenhuisHOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Sonia M CunhaHOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Ellen van der SpekDepartment of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.
Esther G M de WaalDepartment of Internal Medicine, Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands.
Maaike SohneDepartment of Internal Medicine, Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Pieter SonneveldDepartment of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.
Inger S NijhofDepartment of Internal Medicine, Antonius Ziekenhuis, Nieuwegein, the Netherlands.
Saskia K KleinDepartment of Internal Medicine, Meander Medical Center, Amersfoort, the Netherlands.
Niels W C J van de DonkDepartment of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands.
Mark-David LevinDepartment of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
Paula F YpmaDepartment of Internal Medicine, Haga Hospital, Den Haag, the Netherlands.
Sonja ZweegmanDepartment of Hematology, Amsterdam UMC, Vrije Universiteit Amsterdam, the Netherlands.
Erasmus MC Cancer Institute · NLAmsterdam University Medical Centers · NLSt. Antonius Ziekenhuis · NLAlbert Schweitzer Ziekenhuis · NLCliniques Universitaires Saint-Luc · BEDiakonessenhuis hospital · NLFlevoziekenhuis · NLHaga Hospital · NLIkazia Ziekenhuis · NLJeroen Bosch Ziekenhuis · NLMaasstad Ziekenhuis · NLMedisch Centrum Leeuwarden · NLNorthwest Hospital · USRadboud University Nijmegen · NLRijnstate Hospital · NLUniversity Medical Center Groningen · NLZiekenhuis Amstelland · NLZiekenhuis Bernhoven · NLZiekenhuis Gelderse Vallei · NLZiekenhuisnetwerk Antwerpen Stuivenberg · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The outcome of non-transplant eligible newly diagnosed multiple myeloma (NDMM) patients is heterogeneous, partly depending on frailty level. The aim of this study was to prospectively investigate the efficacy and safety of Ixazomib-Daratumumab-low-dose dexamethasone (Ixa-Dara-dex) in NDMM intermediate-fit patients. Methods: In this phase II multicenter HOVON-143 study, IMWG Frailty index based intermediate-fit patients, were treated with 9 induction cycles of Ixa-Dara-dex, followed by maintenance with ID for a maximum of 2 years. The primary endpoint was overall response rate on induction treatment. Patients were included from October 2017 until May 2019. Trial Registration Number: NTR6297. Findings: Sixty-five patients were included. Induction therapy resulted in an overall response rate of 71%. Early mortality was 1.5%. At a median follow-up of 41.0 months, median progression-free survival (PFS) was 18.2 months and 3-year overall survival 83%. Discontinuation of therapy occurred in 77% of patients, 49% due to progression, 9% due to toxicity, 8% due to incompliance, 3% due to sudden death and 8% due to other reasons. Dose modifications of ixazomib were required frequently (37% and 53% of patients during induction and maintenance, respectively), mainly due to, often low grade, polyneuropathy. During maintenance 23% of patients received daratumumab alone. Global quality of life (QoL) improved significantly and was clinically relevant, which persisted during maintenance treatment. Interpretation: Ixazomib-Daratumumab-low-dose dexamethasone as first line treatment in intermediate-fit NDMM patients is safe and improves global QoL. However, efficacy was limited, partly explained by ixazomib-induced toxicity, hampering long term tolerability of this 3-drug regimen. This highlights the need for more efficacious and tolerable regimens improving the outcome in vulnerable intermediate-fit patients. Funding: Janssen Pharmaceuticals, Takeda Pharmaceutical Company Limited.

Indexed as

DaratumumabElderlyIMWG frailty indexIntermediate-fitIxazomibMultiple myeloma

Identifiers

PMID37680948
PMCPMC10481174
OpenAlexW4386268194

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.