Cited by 2,560CAR-T cell therapy researchMultiple Myeloma Research and TreatmentsProtein Degradation and Inhibitors

The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index; 4 of the 10 sources its claims cite were checked for support.

Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma.

Open access

Abstract

BACKGROUND: Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and refractory multiple myeloma. METHODS: CAR-positive (CAR+) T cells. The primary end point was an overall response (partial response or better); a key secondary end point was a complete response or better (comprising complete and stringent complete responses). RESULTS: nucleated cells) was confirmed in 33 patients, representing 26% of all 128 patients who were treated and 79% of the 42 patients who had a complete response or better. The median progression-free survival was 8.8 months (95% confidence interval, 5.6 to 11.6). Common toxic effects among the 128 treated patients included neutropenia in 117 patients (91%), anemia in 89 (70%), and thrombocytopenia in 81 (63%). Cytokine release syndrome was reported in 107 patients (84%), including 7 (5%) who had events of grade 3 or higher. Neurotoxic effects developed in 23 patients (18%) and were of grade 3 in 4 patients (3%); no neurotoxic effects higher than grade 3 occurred. Cellular kinetic analysis confirmed CAR+ T cells in 29 of 49 patients (59%) at 6 months and 4 of 11 patients (36%) at 12 months after infusion. CONCLUSIONS: Ide-cel induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma; MRD-negative status was achieved in 26% of treated patients. Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome. (Funded by bluebird bio and Celgene, a Bristol-Myers Squibb company; KarMMa ClinicalTrials.gov number, NCT03361748.).

Overview

Integrity signals

Registry

Crossref · 10.1056/nejmoa2024850

Cites

18 of 18 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

4 of 10 cited sources checked · 2 supported · 0 flagged · accuracy not yet measured

Show all 66 claims

  • Probably not a substantial claim. 12
  • It may state two separate claims as one. 32
  • The quote only partly states this claim. 1
41 of 41
  • The paper relies on this without support.

    Soluble BCMA is a serum-based universal marker of myeloma burden.

    “Soluble BCMA was assessed as a serum-based universal marker of myeloma burden.”
  • The paper relies on this without support.

    Cross-trial comparisons of progression-free survival between the KarMMa study and trials of selinexor plus dexamethasone or belantamab mafodotin are valid.

    “These efficacy results compare favorably with results in similarly heavily pretreated patients with relapsed or refractory myeloma treated with two recently approved regimens, selinexor plus dexamethasone and belantamab mafodotin (median progression-free survival, 3.7 months and 2.9 months, respectively).5,17”
  • The paper relies on this without support.

    MRD negativity at a sensitivity of 10^-5 is a valid measure of depth of response and clinical benefit.

    “The fact that MRDnegative responses occurred in approximately a quarter of the patients highlights the depth of response induced by ide-cel.”
  • The paper relies on this without support.

    BCMA expression is required for ide-cel efficacy, so lack of tumor BCMA expression would limit its use.

    “Nearly all tumors expressed BCMA, a finding that supports the use of ide-cel in relapsed and refractory myeloma without restriction based on tumor BCMA expression.”
  • The paper relies on this without support.

    The absence of a detectable effect of antidrug antibodies on efficacy is not due to insufficient statistical power.

    “Antidrug antibodies had no effect on the incidence of response or of complete response or better and had no noticeable effect on progression-free survival.”
5 of 5

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Metadata

Authors
Munshi, N. C., Anderson, L. D., Shah, N., Madduri, D., Berdeja, J., Lonial, S., Raje, N., Lin, Y., Siegel, D., Oriol, A., Moreau, P., Yakoub-Agha, I., Delforge, M., Cavo, M., Einsele, H., Goldschmidt, H., Weisel, K., Rambaldi, A., Reece, D., Petrocca, F., Massaro, M., Connarn, J. N., Kaiser, S., Patel, P., Huang, L., Campbell, T. B., Hege, K., & San-Miguel, J.
Affiliations
  • Harvard University (US)
  • Mayo Clinic (US)
  • Hackensack University Medical Center (US)
  • From the Jerome Lipper Multiple Myeloma Center, Dana–Farber Cancer Institute (N.C.M.), the Veterans Affairs Boston Healthcare System, Harvard Medical School (N.C.M.), and Massachusetts General Hospital (N.R.), Boston, and bluebird bio, Cambridge (F.P., M.M.) — all in Massachusetts; Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas (L.D.A.); the University of California, San Francisco, San Francisco (N.S.); Icahn School of Medicine at Mount Sinai, New York ...
Venue
New England Journal of Medicine
Published
2021-02-25
Volume
384
Issue
8
Pages
705-716
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W3133229959
Cited by
2,560
References
17
Citations by year
2026: 411 · 2025: 486 · 2024: 540 · 2023: 493 · 2022: 436 · 2021: 186
FWCI
150.68
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
  • Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion, other-oa)
  • Lirias (KU Leuven) (submittedVersion)
Funders
Bristol-Myers Squibb
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
Keywords
idecabtagene vicleucel, CAR T-cell therapy, relapsed/refractory multiple myeloma, BCMA, minimal residual disease, cytokine release syndrome, neurotoxicity, CAR T cell persistence, progression-free survival, complete response, neutropenia, anemia, thrombocytopenia, chimeric antigen receptor T cells
MeSH terms
Receptors, Chimeric Antigen, Progression-Free Survival, Cytokine Release Syndrome, Adult, Aged, Female, Hematologic Diseases, Humans, Male, Middle Aged, Multiple Myeloma, Recurrence, Biomarkers, Immunotherapy, Adoptive, Drug Resistance, Neoplasm

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

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