Evidence map›Paper›PMID 37341778›Full record

ArticleAnnals of hematology2023

Efficacy and Safety of Ixazomib Plus Lenalidomide and Dexamethasone Following Injectable PI-Based Therapy in Relapsed/Refractory Multiple Myeloma.

Yu Abe, Makoto Sasaki, Naoki Takezako, Shigeki Ito, Kazuhito Suzuki, Hiroshi Handa, Takaaki Chou, Takahiro Yoshida, Ikuo Mori, Tomohiro Shinozaki and 1 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Annals of hematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03416374 (An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 28% 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.

NCT03416374 phase4completednot on this map

An Open-label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy

TypeinterventionalSponsorTakedaRan2018 to 2021Enrolled45ConditionsRelapsed and/or Refractory Multiple MyelomaArmsIxazomib, Bortezomib, Carfilzomib, Lenalidomide, Dexamethasone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Yu AbeDivision of Haematology, Japanese Red Cross Medical Centre, 4 Chome-1-22 Hiroo, Shibuya City, Tokyo, 150-8935, Japan.
Makoto SasakiDivision of Haematology, Department of Internal Medicine, Juntendo University School of Medicine, Tokyo, Japan.
Naoki TakezakoDivision of Haematology, Japan Association for Development of Community Medicine, Nerima Hikarigaoka Hospital, Tokyo, Japan.
Shigeki ItoDivision of Haematology and Oncology, Department of Internal Medicine, Iwate Medical University School of Medicine, Iwate, Japan.
Kazuhito SuzukiDivision of Clinical Oncology and Haematology, Department of Internal Medicine, The Jikei University Kashiwa Hospital, Chiba, Japan.
Hiroshi HandaDepartment of Haematology, Gunma University Graduate School of Medicine, Gunma, Japan.
Takaaki ChouNiigata Kenshin Plaza, General Incorporated Foundation, Health Medicine Prevention Association, Niigata, Japan.
Takahiro YoshidaJapan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Ikuo MoriJapan Medical Affairs, Japan Oncology Business Unit, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Tomohiro ShinozakiDepartment of Information and Computer Technology, Faculty of Engineering, Tokyo University of Science, Tokyo, Japan.
Kenshi SuzukiDivision of Haematology, Japanese Red Cross Medical Centre, 4 Chome-1-22 Hiroo, Shibuya City, Tokyo, 150-8935, Japan. ken-suzuki@mtb.biglobe.ne.jp.ORCID http://orcid.org/0000-0001-7132-5337
Japanese Red Cross Medical Center · JPTakeda (Japan) · JPGunma University · JPIwate Medical University · JPJapan Association for Development of Community Medicine · JPJuntendo University · JPTokyo University of Science · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This nationwide, multicenter, open-label, single-arm study evaluated the efficacy and safety of the oral proteasome inhibitor (PI), ixazomib plus lenalidomide (LEN) and dexamethasone (DEX) (IRd) following injectable PI-based therapy for relapsed/refractory multiple myeloma (RRMM). Of 45 patients enrolled, 36 patients received IRd after achieving at least a minor response to 3 cycles of bortezomib or carfilzomib plus LEN + DEX (VRd, n=6; KRd, n=30). At median follow-up of 20.8 months, the 12-month event-free survival rate (primary endpoint) was 49% (90% CI: 35.9-62.0), counting 11 events of progressive disease/death, 8 dropouts and 4 missing response data. The 12-month progression-free survival (PFS) rate by Kaplan-Meier analysis (dropouts as censoring) was 74% (95% CI: 56-86). Median PFS and time to next treatment (95% CI) were 29.0 (21.3-NE) and 32.3 (14.9-35.4) months, respectively; median OS was not evaluable. The overall response rate was 73%, and 42% of patients had a very good partial response or better. Frequent (≥10% incidence) grade ≥3 treatment emergent adverse events were decreased neutrophil and platelet counts (n=7 [16%] each). Two deaths occurred (one during KRd treatment and one during IRd treatment), both due to pneumonia. IRd following injectable PI-based therapy was tolerable and efficacious in RRMM patients. TRIAL REGISTRATION NUMBER: NCT03416374; Date of registration: January 31, 2018.

Indexed as

Multiple MyelomaAntineoplastic Combined Chemotherapy ProtocolsBoron CompoundsDexamethasoneGlycineHumansLenalidomideBoron CompoundsDexamethasoneGlycineixazomibLenalidomideixazomibmultiple myelomaproteasome inhibitorrelapsed/refractory disease

Identifiers

PMID37341778
PMCPMC10444638
OpenAlexW4381469688

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.