Evidence map›Paper›PMID 31427722›Full record

Trial reportLeukemia2020

A simplified frailty scale predicts outcomes in transplant-ineligible patients with newly diagnosed multiple myeloma treated in the FIRST (MM-020) trial.

Thierry Facon, Meletios A Dimopoulos, Nathalie Meuleman, Andrew Belch, Mohamad Mohty, Wen-Ming Chen, Kihyun Kim, Elena Zamagni, Paula Rodriguez-Otero, William Renwick and 18 more

3 registry-linked trialsAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Leukemia, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 141 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
141citing papers in PubMed, 6 pooled it
–field-weighted citation impact
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.

NCT04891809 phase2active not recruitingnot on this mapstarted 2021, after this paper: background citation

Isatuximab in Combination With Lenalidomide-Dexamethasone Compared to Lenalidomide-Dexamethasone in Elderly Patients (Aged ≥70 Years) With Newly Diagnosed Myeloma: a Randomized Phase II Study (SGZ-2019-12650)

TypeinterventionalSponsorArbeitsgemeinschaft medikamentoese TumortherapieRan2021 to 2028Enrolled198ConditionsNewly Diagnosed Multiple MyelomaArmsIsatuximab-Irfc 20 MG/ML [Sarclisa], Lenalidomide, Dexamethasone Oral
NCT05527340 phase2active not recruitingnot on this mapstarted 2022, after this paper: background citation

Multicenter, Phase II, National and Open-label Study to Evaluate Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

TypeinterventionalSponsorPETHEMA FoundationRan2022 to 2029Enrolled140ConditionsMultiple MyelomaArmsIberdomide, Dexamethasone, Daratumumab
NCT05849610 phase2active not recruitingnot on this mapstarted 2023, after this paper: background citation

An Open Label, Multicenter, Phase 2, Pilot Study, Evaluating Early Treatment With Bispecific T-cell Redirectors (Teclistamab and Talquetamab) in the Frontline Therapy of Newly Diagnosed High-risk Multiple Myeloma

TypeinterventionalSponsorPETHEMA FoundationRan2023 to 2029Enrolled30ConditionsHigh-Risk de Novo Multiple MyelomaArmsDaratumumab, Bortezomib, Lenalidomide, Teclistamab, Talquetamab
3 · Its place in the literature

Who cites it

141 citing papers in PubMed, 6 syntheses or guidelines pooled it.

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  3. Risk factors for preoperative frailty in older patients with gastric cancer: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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81 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Thierry FaconUniv.Lille, CHU Lille, Service des Maladies du Sang, F-59000, Lille, France. thierry.facon@chru-lille.fr.
Meletios A DimopoulosNational and Kapodistrian University of Athens, Athens, Greece.
Nathalie MeulemanJules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium.
Andrew BelchCross Cancer Institute, Edmonton, AB, Canada.
Mohamad MohtyDepartment of Haematology, Saint Antoine Hospital, Paris, France.
Wen-Ming ChenDepartment of Hematology, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.
Kihyun KimSungkyunkwan University Samsung Medical Center, Seoul, Korea.
Elena ZamagniAzienda Ospedaliero-Universitaria, Malpighi, Bologna, Italy.
Paula Rodriguez-OteroUniversity of Navarra, Pamplona, Spain.
William RenwickWestern Health, Melbourne, Australia.
Christian RoseHôpital Saint Vincent de Paul Université Catholique de Lille, Lille, France.
Adrian TempesculCentre Hospitalier Universitaire, Brest, France.
Eileen BoyleNational and Kapodistrian University of Athens, Athens, Greece.
Salomon ManierNational and Kapodistrian University of Athens, Athens, Greece.
Michel AttalInstitut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.
Philippe MoreauUniversity Hospital Hôtel-Dieu, Nantes, France.
Margaret MacroCentre Hospitalier Universitaire, Caen, France.
Xavier LeleuHôpital La Mileterie, Poitiers, France.
Marie Lorraine ChretienCHU de Dijon, Dijon, France.
Heinz LudwigWilhelminen Hospital, Vienna, Austria.
Shien GuoEvidera, Waltham, MA, USA.
Michael SturnioloCelgene Corporation, Summit, NJ, USA.
Antoine TinelCelgene International Sàrl, Boudry, Switzerland.
Mara Silvia MonziniCelgene Corporation, Summit, NJ, USA.
Bruno CostaCelgene International Sàrl, Boudry, Switzerland.
Vanessa HouckCelgene Corporation, Summit, NJ, USA.
Cyrille HulinCentre Hospitalier Universitaire, Bordeaux, France.
Jean Yves MaryHôpital Saint-Louis, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with multiple myeloma are generally older and vary in fitness levels, which may influence the clinical benefit of treatment. Patients from the large, phase 3 FIRST trial in newly diagnosed multiple myeloma (NDMM) were retrospectively investigated to determine outcomes based on frailty using scores for age, Charlson Comorbidity Index (CCI), and Eastern Cooperative Oncology Group performance status (ECOG PS), instead of the EQ-5D quality-of-life questionnaire, as previously reported. ECOG PS (n = 1618) was investigated in frailty groups: frail (49%) and nonfrail (51%). Frail patients experienced worse progression-free and overall survival vs nonfrail patients. Prognostic assessment was improved when combining frailty and International Staging System stage (I/II vs III). Frail patients had a higher risk of developing grade 3/4 treatment-emergent adverse events. Treatment effects observed in the FIRST trial were confirmed per frailty group and per frailty and ISS group. The use of this ECOG PS-containing frailty scale as a predictive measure of clinical outcomes in patients with transplant-ineligible NDMM is supported by data from the FIRST trial. This score, based on age, CCI, and ECOG PS, can be easily replicated and may help design future myeloma studies in frail or nonfrail elderly patients.

Indexed as

FrailtyAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleFrail ElderlyHumansLenalidomideMaleMelphalanMiddle AgedMultiple MyelomaPrednisoneThalidomideDexamethasoneLenalidomideMelphalanPrednisoneThalidomide

Identifiers

PMID31427722
PMCPMC7214253

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.