Evidence map›Paper›PMID 30796199›Full record

Trial reportBlood cancer journal2019

Health-related quality of life in the ENDEAVOR study: carfilzomib-dexamethasone vs bortezomib-dexamethasone in relapsed/refractory multiple myeloma.

Heinz Ludwig, Philippe Moreau, Meletios A Dimopoulos, Maria-Victoria Mateos, Martin Kaiser, Roman Hajek, Shibao Feng, Kim Cocks, Jaqueline Buchanan, Katja Weisel

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood cancer journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01568866 (A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
4.6field-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.

NCT01568866 phase3completednot on this map

A Randomized, Open-label, Phase 3 Study of Carfilzomib Plus Dexamethasone vs. Bortezomib Plus Dexamethasone in Patients With Relapsed Multiple Myeloma

TypeinterventionalSponsorAmgenRan2012 to 2018Enrolled929ConditionsMultiple MyelomaArmsCarfilzomib, Bortezomib, Dexamethasone
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 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

10 authors at 8 institutions in 8 countries.

Heinz LudwigWilhelminen Cancer Research Institute, Wilhelminenhospital, Vienna, Austria. heinz.ludwig.lud@extern.wienkav.at.
Philippe MoreauUniversity of Nantes, Nantes, France.
Meletios A DimopoulosNational and Kapodistrian University of Athens School of Medicine, Athens, Greece.
Maria-Victoria MateosUniversity Hospital Salamanca, Salamanca, Spain.
Martin KaiserThe Institute of Cancer Research, London, UK.
Roman HajekUniversity Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
Shibao FengAmgen Inc, Thousand Oaks, CA, USA.
Kim CocksKCStats Consultancy, Leeds, UK.ORCID http://orcid.org/0000-0003-2595-708X
Jaqueline BuchananAmgen Inc, Thousand Oaks, CA, USA.
Katja WeiselUniversitatsklinikum Tubingen, Tubingen, Germany.
Amgen (United States) · USInstitute of Cancer Research · GBNantes Université · FRNational and Kapodistrian University of Athens · GRUniversidad de Salamanca · ESUniversitätsklinikum Tübingen · DEUniversity of Ostrava · CZWilhelminen Hospital · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We examined effects of carfilzomib-dexamethasone (Kd56) versus bortezomib-dexamethasone (Vd) on health-related quality of life (HR-QoL) in relapsed/refractory multiple myeloma (MM) patients from the ENDEAVOR study. HR-QoL was assessed by the European Organisation for Research and Treatment of Cancer QoL Questionnaire (QLQ-C30), MM-specific module (QLQ-MY20), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-Ntx) "Additional Concerns" neurotoxicity subscale. The QLQ-C30 Global Health Status (GHS)/QoL scale and seven prespecified subscales were compared between groups using mixed model for repeated measures. Of 929 randomized patients, 911 with ≥1 post-baseline assessment were included. Kd56 was associated with statistically significant improvements in GHS/QoL, fatigue, pain, side effects, and FACT/GOG-Ntx scores versus Vd, although mean differences did not meet thresholds for clinical significance. The Kd56 group had longer time to deterioration (TTD) in GHS/QoL (median 3.7 versus 2.8 months, p = 0.0046), physical function (5.6 versus 3.7 months, p = 0.0390), nausea/vomiting (17.6 versus 8.2 months, p = 0.0358), side effects (6.4 versus 3.7 months p < 0.0001), and FACT/GOG-Ntx (11.1 versus 5.5 months, p = 0.0004). Overall, Kd56 resulted in statistically but not clinically significant improvements in mean GHS/QoL scores versus Vd. Treatment with Kd56 versus Vd also significantly prolonged TTD in GHS/QoL, physical function, nausea/vomiting, side effects, and FACT/GOG-Ntx.

Indexed as

Quality of LifeAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBortezomibDexamethasoneDrug Resistance, NeoplasmFemaleHealth Care SurveysHumansMaleMiddle AgedMultiple MyelomaNeoplasm Recurrence, LocalNeoplasm StagingOligopeptidesBortezomibcarfilzomibDexamethasoneOligopeptides

Identifiers

PMID30796199
PMCPMC6386751
OpenAlexW2915197659

What OpenQuestion holds

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LicenceCC BY
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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.