Evidence map›Paper›PMID 23242595›Full record

Trial reportHaematologica2013

Lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in newly diagnosed multiple myeloma patients aged 65 years or older: results of a randomized phase III trial.

Meletios A Dimopoulos, Michel Delforge, Roman Hájek, Martin Kropff, Maria T Petrucci, Philip Lewis, Annabel Nixon, Jingshan Zhang, Jay Mei, Antonio Palumbo

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00405756 (A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde), which is not on this map. Cited by 33 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 4 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.

NCT00405756 phase3completednot on this map

A Phase III, Multicentre, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Parallel Group Study To Determine The Efficacy And Safety Of Lenalidomde (Revlimid®) In Combination With Melphalan And Prednisone Versus Placebo Plus Melphalan And Prednisone In Subjects With Newly Diagnosed Multiple Myeloma Who Are 65 Years Of Age Or Older

TypeinterventionalSponsorCelgene CorporationRan2007 to 2016Enrolled459ConditionsNewly Diagnosed Multiple MyelomaArmsLenalidomide: Double-blind Induction, Melphalan, Prednisone, Aspirin, Placebo
3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  19. High patient satisfaction and increased physical activity following a remote multidisciplinary team multiple myeloma clinic.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Meletios A DimopoulosUniversity of Athens School of Medicine, Alexandra Hospital, Athens, Greece. mdimop@med.uoa.gr
Michel Delforge
Roman Hájek
Martin Kropff
Maria T Petrucci
Philip Lewis
Annabel Nixon
Jingshan Zhang
Jay Mei
Antonio Palumbo

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The MM-015 trial assessed the effect of lenalidomide-based therapy on health-related quality of life. Patients (n=459) with newly diagnosed multiple myeloma aged 65 years or over were randomized 1:1:1 to nine 4-week cycles of lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance; or lenalidomide, melphalan, and prednisone, or melphalan and prednisone, with no maintenance therapy. Patients completed health-related quality of life questionnaires at baseline, after every third treatment cycle, and at treatment end. Health-related quality of life improved in all treatment groups during induction therapy. Patients receiving lenalidomide maintenance had the most pronounced improvements, Global Health Status/Quality of Life (P<0.05), Physical Functioning (P<0.01), and Side Effects of Treatment (P<0.05) out of 6 pre-selected health-related quality of life domains. More patients receiving lenalidomide maintenance achieved minimal important differences (P<0.05 for Physical Functioning). Therefore, lenalidomide, melphalan, and prednisone, followed by lenalidomide maintenance, improves health-related quality of life in patients with newly diagnosed multiple myeloma. (Clinicaltrials.gov identifier NCT00405756).

Indexed as

Quality of LifeAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsHumansInduction ChemotherapyLenalidomideMaintenance ChemotherapyMelphalanMultiple MyelomaPrednisoneSurveys and QuestionnairesThalidomideLenalidomideMelphalanPrednisoneThalidomide

Identifiers

PMID23242595
PMCPMC3640125

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.