Evidence map›Paper›PMID 33326255›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial.

Aurore Perrot, Thierry Facon, Torben Plesner, Saad Z Usmani, Shaji Kumar, Nizar J Bahlis, Cyrille Hulin, Robert Z Orlowski, Hareth Nahi, Peter Mollee and 16 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. 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 NCT05527340 (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.), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 9% 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.

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
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 18 institutions in 9 countries.

Aurore PerrotHematology Department, Cancer University Institute Oncopole, Toulouse, France.
Thierry FaconService des Maladies du Sang, Hôpital Claude Huriez, Lille, France.
Torben PlesnerVejle Hospital and University of Southern Denmark, Vejle, Denmark.
Saad Z UsmaniLevine Cancer Institute/Atrium Health, Charlotte, NC.
Shaji KumarDepartment of Hematology, Mayo Clinic Rochester, Rochester, MN.
Nizar J BahlisUniversity of Calgary, Arnie Charbonneau Cancer Research Institute, Calgary, AB, Canada.
Cyrille HulinDepartment of Hematology, Hospital Haut Leveque, University Hospital, Pessac, France.
Robert Z OrlowskiDepartment of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.
Hareth NahiDivision of Hematology, Department of Medicine, Karolinska Institute, Karolinska University Hospital at Huddinge, Stockholm, Sweden.
Peter MolleePrincess Alexandra Hospital and University of Queensland, Brisbane, Australia.
Karthik RamasamyOxford University Hospital and NIHR BRC Blood Theme, Oxford, United Kingdom.
Murielle RousselHematology Department, Cancer University Institute Oncopole, Toulouse, France.
Arnaud JaccardCentre Hospitalier Universitaire, Limoges, France.
Michel DelforgeDepartment of Hematology, University Hospital Leuven, Belgium.
Lionel KarlinCentre Hospitalier Lyon-Sud Hematologie (HCL), Pierre-Benite Cedex, France.
Bertrand ArnulfHematology/Oncology, Hopital Saint Louis, Paris, France.
Ajai ChariTisch Cancer Institute, Mount Sinai School of Medicine, New York, NY.
Jianming HeJanssen Global Services, Raritan, NJ.
Kai Fai HoSTAT-TU Inc, Toronto, ON, Canada.
Rian Van RampelberghJanssen Research & Development, Beerse, Belgium.
Clarissa M UhlarJanssen Research & Development, Raritan, NJ.
Jianping WangJanssen Research & Development, Raritan, NJ.
Rachel KobosJanssen Research & Development, Raritan, NJ.
Katharine S GriesJanssen Global Services, Raritan, NJ.
John FastenauJanssen Global Services, Raritan, NJ.
Katja WeiselDepartment of Oncology, Hematology, BMT with Department of Pneumology, University Medical Center Hamburg, Hamburg, Germany.
Janssen (United States) · USInstitut universitaire du cancer de Toulouse Oncopole · FRPrincess Alexandra Hospital · AUCentre Hospitalier Universitaire de Limoges · FRHôpital Cardiologique du Haut-Lévêque · FRHôpital Claude Huriez · FRHôpital Lyon Sud · FRHôpital Saint-Louis · FRIcahn School of Medicine at Mount Sinai · USInstitute of Cancer Research · CAJanssen (Belgium) · BEKarolinska University Hospital · SEKU Leuven · BELevine Cancer Institute · USMayo Clinic · USThe University of Texas MD Anderson Cancer Center · USUniversity Medical Center Hamburg-Eppendorf · DEUniversity of Southern Denmark · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study. PATIENTS AND

methodsPROs were assessed on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item and the EuroQol 5-dimensional descriptive system at baseline and every 3 months during treatment. By mixed-effects model, changes from baseline are presented as least squares means with 95% CIs.

resultsA total of 737 transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma were randomly assigned to D-Rd (n = 368) or Rd (n = 369). Compliance with PRO assessments was high at baseline (> 90%) through month 12 (> 78%) for both groups. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item global health status scores improved from baseline in both groups and were consistently greater with D-Rd at all time points. A global health status benefit was achieved with D-Rd, regardless of age (< 75 and ≥ 75 years), baseline Eastern Cooperative Oncology Group (ECOG) performance status score, or depth of response. D-Rd treatment resulted in significantly greater reduction in pain scores as early as cycle 3 (

conclusionD-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in PROs, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.

Indexed as

Patient Reported Outcome MeasuresQuality of LifeAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsDexamethasoneFemaleHumansLenalidomideMaleMiddle AgedMultiple MyelomaPain MeasurementTime FactorsTreatment OutcomeAntibodies, MonoclonaldaratumumabDexamethasoneLenalidomide

Identifiers

PMID33326255
PMCPMC8078427
OpenAlexW3112002107

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.