Evidence map›Paper›PMID 34559902›Full record

Trial reportAmerican journal of hematology2021

A phase I/II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202).

Peter M Voorhees, Vera J Suman, Sascha A Tuchman, Jacob P Laubach, Hani Hassoun, Yvonne A Efebera, Flora Mulkey, Misty Bova-Solem, Katelyn Santo, Destin Carlisle and 2 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in American journal of hematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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.

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

11 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Review
  11. Review
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

12 authors.

Peter M VoorheesDepartment of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.ORCID 0000-0003-1661-718X
Vera J SumanAlliance Statistics and Data Center, Rochester, Minnesota, USA.
Sascha A TuchmanDivision of Hematology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
Jacob P LaubachDepartment of Hematology and Oncology, Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, Massachusetts, USA.
Hani HassounMyeloma Service, Division of Hematologic Oncology, Department of Medicine, Memorial Sloan Cancer Center, New York, New York, USA.
Yvonne A EfeberaDivision of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, USA.
Flora MulkeyAlliance Statistics and Data Center, Duke University, Durham, North Carolina, USA.
Misty Bova-SolemAlliance for Clinical Trials in Oncology, Protocol Operations Program, Chicago, Illinois, USA.
Katelyn SantoAlliance Statistics and Data Center, Rochester, Minnesota, USA.
Destin CarlisleAlliance for Clinical Trials in Oncology, Protocol Operations Program, Chicago, Illinois, USA.
Philip L McCarthyTransplant and Cellular Therapy Program, Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.
Paul G RichardsonDivision of Hematology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.ORCID 0000-0002-7426-8865

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI AKHILESH PANDEY · 1985 to 2026
$151.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
UNC Lead Academic Participating SiteUG1CA233373 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI CAREY, LISA A, DEES, ELIZABETH CLAIRE · 2019 to 2025
$3.5M
Network Lead Academic Participating Site Grant from the Roswell Park Cancer InstituteUG1CA233191 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LELE, SHASHIKANT, LEVINE, ELLIS G · 2019 to 2025
$3.1M
National Cancer Institute of the National Institutes of Health U10CA180882National Cancer Institute of the National Institutes of Health UG1CA233290National Cancer Institute of the National Institutes of Health UG1CA233331National Cancer Institute of the National Institutes of Health UG1CA233373NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233373
6 · The paper itself

Abstract

Preclinical studies have demonstrated activity of the oral proteasome inhibitor (PI) ixazomib (IXA) in bortezomib-resistant multiple myeloma (MM) and synergy with immunomodulatory drugs. We therefore conducted a phase I/II study to establish the safety and preliminary efficacy of IXA with pomalidomide (POM) and dexamethasone (DEX) in lenalidomide (LEN)/PI-refractory MM. Dose escalation established a 4 mg dose of POM and IXA and 20/40 mg dose of DEX as the maximum tolerated dose. The phase II portion of the trial was redesigned and started anew after six patients had been randomized to IXA-POM-DEX due to a rapidly changing treatment landscape. Among the 29 evaluable LEN/PI-refractory patients treated with IXA-POM-DEX in phase I/II, the overall response rate (partial response or better) was 51.7% with a median duration of response of 16.8 months (range 56 days to 4.1 years), median progression-free survival of 4.4 months (95% confidence interval [CI]: 3.0-18.4), and median overall survival of 34.3 months (95% CI: 19.2 to not reached). Hematologic, gastrointestinal, and constitutional adverse events were common and consistent with the side-effect profiles of the individual agents. Our results support further evaluation of this all-oral regimen in relapsed/refractory MM.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoron CompoundsDexamethasoneDrug Resistance, NeoplasmFemaleGlycineHumansLenalidomideMaleMaximum Tolerated DoseMiddle AgedMultiple MyelomaProteasome InhibitorsThalidomideBoron CompoundsDexamethasoneGlycineixazomibLenalidomidepomalidomideProteasome InhibitorsThalidomide

Identifiers

PMID34559902
PMCPMC8713771

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.