Evidence map›Paper›PMID 33021870›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial.

Meletios A Dimopoulos, Ivan Špička, Hang Quach, Albert Oriol, Roman Hájek, Mamta Garg, Meral Beksac, Sara Bringhen, Eirini Katodritou, Wee-Joo Chng and 10 more

Erratum issuedOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 40 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 6 pooled it
7.3field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 6 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 17 institutions in 11 countries.

Meletios A DimopoulosHematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.
Ivan ŠpičkaFirst Department of Medicine, Department of Hematology, First Faculty of Medicine, Charles University and General Hospital in Prague, Prague, Czech Republic.
Hang QuachDepartment of Hematology, University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.
Albert OriolInstitut d'Investigació contra la Leucèmia Josep Carreras and Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Badalona, Spain.
Roman HájekDepartment of Hemato-oncology, University Hospital Ostrava, University of Ostrava, and Faculty of Medicine, Ostrava, Czech Republic.
Mamta GargHematology, Leicester Royal Infirmary/University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.
Meral BeksacDepartment of Hematology, Ankara University, Ankara, Turkey.
Sara BringhenDivision of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
Eirini KatodritouDepartment of Hematology, Theagenion Cancer Hospital, Thessaloniki, Greece.
Wee-Joo ChngDepartment of Hematology-Oncology, National University Cancer Institute, National University Health System, and Yong Loo Lin School of Medicine and Cancer Science Institute of Singapore, National University of Singapore, Singapore.
Xavier LeleuPôle Régional de Cancérologie, Department of Haematology, Centre Hospitalier Universitaire La Milétrie-Poitiers, Poitiers, France.
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
María-Victoria MateosHematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Celular del Cáncer, (Universitario de Salamanca Consejo Superior de Investigaciones Científicas), Salamanca, Spain.
Gareth MorganPerlmutter Cancer Center, NYU Langone Health, New York, NY.
Alexander VorogMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.
Richard LabotkaMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.
Bingxia WangMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.
Antonio PalumboMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA.
Sagar LonialDepartment of Hematology and Medical Oncology, Winship Cancer Institute of Emory University, Atlanta, GA.
TOURMALINE-MM4 study group
Millennium Engineering and Integration (United States) · USTakeda (United States) · USAnkara University · TRAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITCentre Hospitalier Universitaire de Poitiers · FRCentro de Investigación del Cáncer · ESEmory University · USGeneral University Hospital in Prague · CZInstitut Català d'Oncologia · ESLeicester Royal Infirmary · GBNagoya City University · JPNational and Kapodistrian University of Athens · GRNational University of Singapore · SGNYU Langone Health · USTheageneio General Hospital · GRUniversity of Melbourne · AUUniversity of Ostrava · CZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeMaintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. Other options that complement the induction regimen with favorable toxicity are needed. PATIENTS AND

methodsThe phase III, double-blind, placebo-controlled TOURMALINE-MM4 study randomly assigned (3:2) patients with NDMM not undergoing ASCT who achieved better than or equal to partial response after 6-12 months of standard induction therapy to receive the oral proteasome inhibitor (PI) ixazomib or placebo on days 1, 8, and 15 of 28-day cycles as maintenance for 24 months. The primary endpoint was PFS since time of randomization.

resultsPatients were randomly assigned to receive ixazomib (n = 425) or placebo (n = 281). TOURMALINE-MM4 met its primary endpoint with a 34.1% reduction in risk of progression or death with ixazomib versus placebo (median PFS since randomization, 17.4

conclusionIxazomib maintenance prolongs PFS with no unexpected toxicity in patients with NDMM not undergoing ASCT. To our knowledge, this is the first PI demonstrated in a randomized clinical trial to have single-agent efficacy for maintenance and is the first oral PI option in this patient population.

Indexed as

AgedAntineoplastic AgentsBoron CompoundsDouble-Blind MethodFemaleGlycineHumansMaintenance ChemotherapyMaleMiddle AgedMultiple MyelomaPlacebosProgression-Free SurvivalProteasome InhibitorsStem Cell TransplantationTreatment OutcomeAntineoplastic AgentsBoron CompoundsGlycineixazomibPlacebosProteasome Inhibitors

Identifiers

PMID33021870
PMCPMC7768338
OpenAlexW3092622634

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.