Evidence map›Paper›PMID 29514706›Full record

ArticleTrials2018

The role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma (ACCoRd [UK-MRA Myeloma XII] trial): study protocol for a Phase III randomised controlled trial.

Alina Striha, A John Ashcroft, Anna Hockaday, David A Cairns, Karen Boardman, Gwen Jacques, Cathy Williams, John A Snowden, Mamta Garg, Jamie Cavenagh and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03562169 (A Phase III Study to Determine the Role of Ixazomib as an Augmented Conditioning Therapy in Salvage Autologous Stem Cell Transplant), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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.

NCT03562169 phase3recruitingnot on this map

A Phase III Study to Determine the Role of Ixazomib as an Augmented Conditioning Therapy in Salvage Autologous Stem Cell Transplant (ASCT) and as a Post-ASCT Consolidation and Maintenance Strategy in Patients With Relapsed Multiple Myeloma

TypeinterventionalSponsorUniversity of LeedsRan2017 to 2027Enrolled406ConditionsMultiple MyelomaArmsIxazomib, thalidomide, & dexamethasone (ITD) re-induction, Conventional autologous stem cell transplant (ASCT-con), Augmented autologous stem cell transplant (ASCT-aug), ITD consolidation and ixazomib maintenance vs. No further therapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
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

15 authors at 10 institutions in 1 country.

Alina StrihaClinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
A John AshcroftDepartment of Haematology, Pinderfields General Hospital, Wakefield, UK.
Anna HockadayClinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
David A CairnsClinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Karen BoardmanClinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Gwen JacquesClinical Trials Research Unit (CTRU), Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Cathy WilliamsCentre for Clinical Haematology, Nottingham University Hospitals (City Campus), Nottingham, UK.
John A SnowdenDepartment of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Mamta GargLeicester Royal Infirmary, Leicester, UK.
Jamie CavenaghDepartment of Haematology, St Bartholomew's Hospital, London, UK.
Kwee YongDepartment of Haematology, University College Hospital, London, UK.
Mark T DraysonMyeloma Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Roger OwenHMDS, St James's University Hospital, Leeds, UK.
Mark CookCentre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Birmingham, UK.
Gordon CookLeeds Institute of Cancer & Pathology, University of Leeds, St James's University Hospital, Leeds, UK. G.Cook@leeds.ac.uk.ORCID http://orcid.org/0000-0003-1717-0412
University of Leeds · GBLeicester Royal Infirmary · GBNottingham University Hospitals NHS Trust · GBPinderfields Hospital · GBSheffield Teaching Hospitals NHS Foundation Trust · GBSt Bartholomew's Hospital · GBSt James's University Hospital · GBUniversity College Hospital · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Birmingham · GB

Funding

Cancer Research UK 19272Cancer Research UK (A19272) CRUK/15/008
6 · The paper itself

Abstract

backgroundMultiple myeloma (MM) is a plasma cell tumour with an approximate annual incidence of 4500 in the UK. Therapeutic options for patients with MM have changed in the last decade with the arrival of proteasome inhibitors and immunomodulatory drugs. Despite these options, almost all patients will relapse post first-line autologous stem cell transplantation (ASCT). First relapse management (second-line treatment) has evolved in recent years with an expanding portfolio of novel agents, driving response rates influencing the durability of response. A second ASCT, as part of relapsed disease management (salvage ASCT), has been shown to prolong the progression-free survival and overall survival following a proteasome inhibitor-containing re-induction regimen, in the Cancer Research UK-funded National Cancer Research Institute Myeloma X (Intensive) study. It is now recommended that salvage ASCT be considered for suitable patients by the International Myeloma Working Group and the National Institute for Health and Care Excellence NG35 guidance. METHODS/

designACCoRd (Myeloma XII) is a UK-nationwide, individually randomised, multi-centre, multiple randomisation, open-label phase III trial with an initial single intervention registration phase aimed at relapsing MM patients who have received ASCT in first-line treatment. We will register 406 participants into the trial to allow 284 and 248 participants to be randomised at the first and second randomisations, respectively. All participants will receive re-induction therapy until maximal response (four to six cycles of ixazomib, thalidomide and dexamethasone). Participants who achieve at least stable disease will be randomised (1:1) to receive either ASCT DISCUSSION: The question of how best to maximise the durability of response to salvage ASCT warrants clinical investigation. Given the expanding scope of oral therapeutic agents, patient engagement with long-term maintenance strategies is a real opportunity. This study will provide evidence to better define post-relapse treatment in MM.

trial registrationISRCTN, ISRCTN10038996 . Registered on 15 December 2016.

Indexed as

Antineoplastic AgentsBoron CompoundsClinical Trials, Phase III as TopicDrug Administration ScheduleFemaleGlycineHumansMaintenance ChemotherapyMaleMulticenter Studies as TopicMultiple MyelomaNeoplasm, ResidualProgression-Free SurvivalProteasome InhibitorsQuality of LifeRandomized Controlled Trials as TopicAntineoplastic AgentsBoron CompoundsGlycineixazomibProteasome InhibitorsASCTAugmented ASCTDepth of responseHaematologyMultiple myelomaRandomised

Identifiers

PMID29514706
PMCPMC5842589
OpenAlexW2797277339

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.