Evidence map›Paper›PMID 36690910›Full record

Trial reportInternational journal of hematology2023

Phase 2 results of idecabtagene vicleucel (ide-cel, bb2121) in Japanese patients with relapsed and refractory multiple myeloma.

Daisuke Minakata, Tadao Ishida, Kiyoshi Ando, Rikio Suzuki, Junji Tanaka, Shotaro Hagiwara, Revathi Ananthakrishnan, Shigeki Kuwayama, Mitsufumi Nishio, Yoshinobu Kanda and 1 more

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 6 pooled it
4.8field-weighted citation impact, top 5% 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

19 citing papers in PubMed, 6 syntheses or guidelines pooled it, 21 citations in OpenAlex.

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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

11 authors at 6 institutions in 2 countries.

Daisuke MinakataDivision of Hematology, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. daisuke_minakata_kappa@yahoo.co.jp.ORCID http://orcid.org/0000-0002-0217-8107
Tadao IshidaDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Rikio SuzukiDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Junji TanakaDepartment of Hematology, Tokyo Women's Medical University, Tokyo, Japan.
Shotaro HagiwaraDepartment of Hematology, Tokyo Women's Medical University, Tokyo, Japan.
Revathi AnanthakrishnanBristol Myers Squibb, Princeton, NJ, USA.
Shigeki KuwayamaBristol Myers Squibb K.K, Tokyo, Japan.
Mitsufumi NishioBristol Myers Squibb K.K, Tokyo, Japan.
Yoshinobu KandaDivision of Hematology, Department of Medicine, Jichi Medical University, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan.
Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Bristol-Myers Squibb (Japan) · JPJapanese Red Cross Medical Center · JPJichi Medical University · JPTokai University · JPUniversity of Tsukuba · JPBristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn the phase 2 KarMMa trial, patients with relapsed/refractory multiple myeloma (RRMM) achieved deep and durable responses with idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T cell therapy. Here we report a sub-analysis of the Japanese cohort of KarMMa.

methodsAdult patients with RRMM who had received  ≥ 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody, and had disease refractory to last treatment received ide-cel at a target dose of 450 × 10

resultsNine patients were treated with ide-cel. The overall response rate was 89% (median follow-up, 12.9 months). The best overall response was stringent complete response in 5 patients (56%), very good partial response in 3 (33%), and stable disease in 1. Median duration of response was not reached. All patients experienced grade ≤ 2 cytokine release syndrome and one patient experienced grade 2 neurotoxicity, but all resolved. Two patients died, one each from plasma cell myeloma and general health deterioration.

conclusionIde-cel yielded deep, durable responses with a tolerable and predictable safety profile in Japanese patients with RRMM. These results are similar to those of the non-Japanese population in KarMMa.

Indexed as

Multiple MyelomaNeoplasms, Plasma CellReceptors, Chimeric AntigenAdultCytokine Release SyndromeHumansImmunotherapy, Adoptiveidecabtagene vicleucelReceptors, Chimeric AntigenCAR T cell therapyIdecabtagene-vicleucelJapanese patientsRelapsed/refractory multiple myelomaTriple-class exposed

Identifiers

PMID36690910
PMCPMC10121508
OpenAlexW4317815006

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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.