Evidence map›Paper›PMID 27702799›Full record

Trial reportBlood2016

Randomized phase 2 trial of ixazomib and dexamethasone in relapsed multiple myeloma not refractory to bortezomib.

Shaji K Kumar, Betsy R LaPlant, Craig B Reeder, Vivek Roy, Alese E Halvorson, Francis Buadi, Morie A Gertz, P Leif Bergsagel, Angela Dispenzieri, Melanie A Thompson and 15 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01415882 (Phase 2 Trial of Ixazomib Combinations in Patients With Relapsed Multiple Myeloma), which is not on this map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 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.

NCT01415882 phase2completednot on this map

Phase 2 Trial of Ixazomib Combinations in Patients With Relapsed Multiple Myeloma

TypeinterventionalSponsorMayo ClinicRan2012 to 2025Enrolled165ConditionsRecurrent Plasma Cell Myeloma, Refractory Plasma Cell MyelomaArmsCyclophosphamide, Daratumumab, Dexamethasone, Ixazomib Citrate, Laboratory Biomarker Analysis
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  12. Why are long-lived plasma cells long-lived?Frontiers in immunology · 2026
    Review
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  20. How I treat a refractory myeloma patient who is not eligible for a clinical trial.Hematology. American Society of Hematology. Education Program · 2019
    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

25 authors.

Shaji K KumarDivision of Hematology and.ORCID 0000-0001-5392-9284
Betsy R LaPlantDepartment of Biostatistics, Mayo Clinic. Rochester, MN.
Craig B ReederDivision of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ; and.
Vivek RoyDivision of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.
Alese E HalvorsonDepartment of Biostatistics, Mayo Clinic. Rochester, MN.
Francis BuadiDivision of Hematology and.
Morie A GertzDivision of Hematology and.
P Leif BergsagelDivision of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ; and.
Angela DispenzieriDivision of Hematology and.
Melanie A ThompsonDivision of Hematology and.
Jamie CrawleyDivision of Hematology and.
Prashant KapoorDivision of Hematology and.
Joseph MikhaelDivision of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ; and.
Keith StewartDivision of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ; and.
Suzanne R HaymanDivision of Hematology and.
Yi L HwaDivision of Hematology and.
Wilson GonsalvesDivision of Hematology and.
Thomas E WitzigDivision of Hematology and.
Sikander AilawadhiDivision of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.
David DingliDivision of Hematology and.
Ronald S GoDivision of Hematology and.
Yi LinDivision of Hematology and.
Candido E RiveraDivision of Hematology and Oncology, Mayo Clinic, Jacksonville, FL.
S Vincent RajkumarDivision of Hematology and.
Martha Q LacyDivision of Hematology and.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Project 4: Targeting Resistance to T-Cell Directed Therapy in Multiple MyelomaP50CA186781 · NCI · MAYO CLINIC ARIZONA · PI Rafael Fonseca · 2015 to 2026
$25.5M
Prevalence and Progression of Monoclonal GammopathiesR01CA107476 · NCI · MAYO CLINIC ROCHESTER · PI KUMAR, SHAJI KUNNATHU, RAJKUMAR, S VINCENT · 2004 to 2018
$4.6M
Onset and biomarkers for progression of monoclonal gammopathiesR01CA168762 · NCI · MAYO CLINIC ROCHESTER · PI KUMAR, SHAJI KUNNATHU, RAJKUMAR, S VINCENT · 2012 to 2024
$3.2M
NCI NIH HHS P30 CA015083NCI NIH HHS P50 CA186781NCI NIH HHS R01 CA107476NCI NIH HHS R01 CA168762
6 · The paper itself

Abstract

Proteasome inhibitors have become an integral part of myeloma therapy. Considerable efforts have gone into optimizing this therapeutic approach to obtain maximal proteasome inhibition with least toxicity. Ixazomib is the first oral proteasome inhibitor to enter the clinic and has been studied as a single agent as well as in various combinations. The current trial was designed to examine the efficacy and toxicity of combining 2 different doses of ixazomib (4 mg and 5.5 mg given weekly for 3 of 4 weeks) with 40 mg weekly of dexamethasone, in relapsed myeloma. Seventy patients were enrolled, 35 patients randomly assigned to each ixazomib dose. Overall, 30 (43%; 95% confidence interval, 31-55) of the patients achieved a confirmed partial response or better, with 31% achieving a response with 4 mg and 54% with 5.5 mg of ixazomib. The median event-free survival (EFS) for the entire study population was 8.4 months; 1-year overall survival was 96%. The EFS was 5.7 months for patients with prior bortezomib exposure and 11.0 months for bortezomib-naïve patients. A grade 3 or 4 adverse event considered at least possibly related to treatment was seen in 11 (32%) patients at 4 mg and in 21 (60%) at 5.5 mg. Dose reductions were more frequent with 5.5 mg dose. Overall, the ixazomib with dexamethasone has good efficacy in relapsed myeloma, is well-tolerated and with higher response rate at 5.5 mg, albeit with more toxicity. This study was registered at www.clinicaltrials.gov as #NCT01415882.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoron CompoundsBortezomibDexamethasoneDrug Resistance, NeoplasmFemaleGlycineHumansMaleMiddle AgedMultiple MyelomaNeoplasm Recurrence, LocalSurvival AnalysisTreatment OutcomeBoron CompoundsBortezomibDexamethasoneGlycineixazomib

Identifiers

PMID27702799
PMCPMC5114487

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.