Cited by 209Multiple Myeloma Research and TreatmentsNeutropenia and Cancer InfectionsMonoclonal and Polyclonal Antibodies Research

Monitoring, prophylaxis, and treatment of infections in patients with MM receiving bispecific antibody therapy: consensus recommendations from an expert panel

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Raje, Noopur, Anderson, Kenneth, Einsele, Hermann, Efebera, Yvonne, Gay, Francesca, Hammond, Sarah P., Lesokhin, Alexander M., Lonial, Sagar +5 more·2023·Blood Cancer Journal

Abstract

Bispecific antibodies (BsAbs) are emerging as an important novel class of immunotherapeutic agents for the treatment of multiple myeloma (MM), and are set to be more widely used in clinical practice. However, this new class of therapies is associated with a distinct adverse event (AE) profile that includes cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, as well as AEs leading to increased infection risk such as cytopenias and hypogammaglobulinemia, and infections themselves. As preliminary data with this class of agents shows an increased risk of infections as compared with conventional MM treatment regimens, such as immunomodulatory drugs, proteasome inhibitors, and anti-CD38 monoclonal antibodies (mAbs), guidance on infection monitoring, prophylaxis and treatment is required. This review provides consensus recommendations from a panel of 13 global experts, following a meeting in August 2022. The meeting objective was to review existing literature and identify relevant information on infections with all BsAbs in patients with MM, as well as to discuss clinical experience of experts in managing these infections. The recommendations outlined here can be used to guide management of infection risk factors, such as hypogammaglobulinemia and neutropenia. In addition, they can be used to guide the monitoring, prophylaxis, and treatment of bacterial, viral and fungal infections, including emerging infections of interest, such as coronavirus 2019 (COVID-19), and the use of vaccinations prior to and during BsAb treatment. The recommendations have been graded by the panel based on level of data available. Key recommendations include universal herpes simplex and varicella zoster virus prophylaxis, screening for hepatitis B virus reactivation risk in all patients, monthly intravenous immunoglobulin treatment for immunoparesis and in the absence of life-threatening infectious manifestations, use of colony-stimulating factors in patients with Grade 3 neutropenia, universal pneumocystis jirovecii pneumonia prophylaxis and no routine anti-fungal prophylaxis.

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  • Early infection prevention, including immunoglobulin replacement per IMWG guidelines, reduces high-grade infections in patients receiving bispecific antibodies.

    “Results further emphasize the importance of early infection prevention in patients receiving bispecific antibodies, including use of immunoglobulin replacement per IMWG guidelines to reduce high-grade infections.36–40”

    From Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma (2026) · cites this paper as [36]

    The Consensus recommendations (Risk factors for infection; page not provided) recommend monthly IVIG for patients with immunoparesis receiving bispecific antibodies, and discuss immunoglobulin replacement for patients at particular infection risk. The passages do not identify these as IMWG guidelines or report that early replacement reduces high-grade infections; the claim states that outcome more firmly than this source supports. (LLM, conf=0.85)

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1 of the 72 references couldn’t be matched to a known paper.

Research works printed but not linked: 3

  1. [7]Pfizer. Pfizer’s elranatamab granted FDA breakthrough therapy designation for relapsed or refractory multiple myeloma. 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-granted-fda-breakthrough-therapy.
  2. [8]Pfizer. Pfizer’s elranatamab receives FDA and EMA filing acceptance. 2023. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-elranatamab-receives-fda-and-ema-filing-acceptance.
  3. [49]Voorhees, P. A Phase 1 first-in-human study of ABBV-383, a BCMA x CD3 bispecific T-Cell-redirecting Antibody, As Monotherapy In Patients With Relapsed/refractory Multiple Myeloma. American Society Of Hematology (ASH) Annual Meeting and Exposition, 2022. PMC9622641 36029527

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Authors
Raje, N., Anderson, K., Einsele, H., Efebera, Y., Gay, F., Hammond, S. P., Lesokhin, A. M., Lonial, S., Ludwig, H., Moreau, P., Patel, K., Ramasamy, K., & Mateos, M.-V.
Affiliations
  • Harvard University (US)
  • Dana-Farber Cancer Institute (US)
  • Universitätsklinikum Würzburg (DE)
  • OhioHealth (US)
  • Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
  • Massachusetts General Hospital (US)
  • Memorial Sloan Kettering Cancer Center (US)
  • Emory University (US)
  • Wilhelminen Hospital (AT)
  • Centre Hospitalier Universitaire de Nantes (FR)
  • The University of Texas MD Anderson Cancer Center (US)
  • University of Oxford (GB)
Corresponding author
Raje, Noopur
Venue
Blood Cancer Journal
Published
2023-08-01
Volume
13
Issue
1
Pages
116-116
ISSN
2044-5385 (ISSN-L)
OpenAlex
W4385456897
Cited by
209
References
72
Citations by year
2026: 81 · 2025: 64 · 2024: 54 · 2023: 10
FWCI
43.17
Type
journal article
Language
en
Open access
Locations
  • Blood Cancer Journal (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
Pfizer
Topics
  • Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
  • Health Sciences › Medicine › Oncology › Neutropenia and Cancer Infections
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
Keywords
multiple myeloma, bispecific antibodies, infection risk, infection control, infection treatment, hypogammaglobulinemia, neutropenia, COVID-19 pandemic, HBV reactivation, intravenous immunoglobulin, colony-stimulating factors, Pneumocystis carinii pneumonia prophylaxis, antifungal prophylaxis, viral and bacterial infections
MeSH terms
COVID-19, Agammaglobulinemia, Humans, Multiple Myeloma, Neutropenia, Antibodies, Bispecific, Neurotoxicity Syndromes, Consensus

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