Plain Language Summary
What is this summary about?
This summary describes management of two side effects in the MajesTEC-1 clinical study, which tested the cancer drug teclistamab in participants with multiple myeloma. These side effects were cytokine release syndrome (CRS) and infections.
What were the results?
In the MajesTEC-1 study, 63% of participants had their multiple myeloma improve; 72% of participants developed CRS, and 80% had an infection. CRS was mostly low grade, occurred during the initial stage when participants received lower teclistamab doses, and was manageable. No participants stopped teclistamab entirely for CRS. Participants taking teclistamab had several types of infections. Some participants receiving teclistamab had low levels of immune cells and antibodies, which help the body fight infections. People with multiple myeloma should be screened for infections. Ongoing infections should be completely resolved before receiving teclistamab.
What do these results mean?
Most MajesTEC-1 study participants had their multiple myeloma respond to teclistamab treatment. People receiving teclistamab should be aware of the risk of developing CRS and infections and report symptoms to their healthcare team. Healthcare teams should monitor people carefully and not give teclistamab to people with active CRS or infection.
Clinical trial number: NCT04557098
KEYWORDS: cytokine release syndrome, multiple myeloma, bispecific antibody, immunotherapy, plain language summary
Acknowledgments
Johnson & Johnson would like to thank all the people who took part in this study as well as their families and caregivers; the physicians, nurses, and staff at the clinical sites; and the scientific staff for their assistance.
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Disclosure statement
Thomas G. Martin has received research funding (institutional) from Amgen, Johnson & Johnson, Sanofi, and Seattle Genetics; and consultancy for GlaxoSmithKline and Roche. Niels W.C.J. van de Donk has received research support from AMGEN, BMS, Celgene, Cellectis, Johnson & Johnson, and Novartis; and serves on advisory boards for AbbVie, Adaptive, AMGEN, Bayer, BMS, Celgene, Johnson & Johnson, Kite Pharma, Merck, Novartis, Pfizer, Roche, Sanofi, Servier, and Takeda, all paid to institution. Paula Rodríguez-Otero reports consulting or advisory roles with AstraZeneca, BMS, GSK, Johnson & Johnson, Menarini Stemline, Oncopeptides, Pfizer, Regeneron, Roche, and Sanofi; is a member of an advisory committee for BMS, Johnson & Johnson, and Regeneron; has received research funding from Pfizer; and is a speaker’s bureau member for Johnson & Johnson. María-Victoria Mateos reports honoraria from and membership on a board of directors and/or advisory committee for Amgen, Bristol-Myers Squibb/Celgene, GlaxoSmithKline, Johnson & Johnson, Pfizer, Sanofi, and Takeda; is a speaker bureau member for Johnson & Johnson; and is a board of directors and/or advisory committee member for Oncopeptides. Rachel Kobos, Katherine Chastain, and Margaret Doyle are employees of Johnson & Johnson. Ajay K. Nooka has served on advisory boards and received honoraria from Adaptive Biotechnologies, Amgen, BeyondSpring, Bristol-Myers Squibb, Cellectar Biosciences, GlaxoSmithKline, Johnson & Johnson, Karyopharm Therapeutics, Oncopeptides, ONK Therapeutics, Pfizer, Sanofi, Secura Bio, and Takeda; received grant/research support (to university) from Aduro Biotech, Amgen, Arch Oncology, Bristol-Myers Squibb, Cellectar Biosciences, Cellectis, Genentech, GlaxoSmithKline, Johnson & Johnson, Karyopharm Therapeutics, Kite Pharma, Merck, Pfizer, and Takeda; and received grant/research support for investigator-initiated studies from Amgen, GlaxoSmithKline, Johnson & Johnson, Merck, and Takeda. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
This summary was prepared by Niraja Suresh, PhD, CMPP, of Eloquent, part of Envision Ignite, an Envision Medical Communications agency, a part of Envision Pharma Group, and funded by Johnson & Johnson. The original authors of the full articles were involved in preparing this summary.
Patient reviewers on this PLSP have received honorarium from Future Oncology for their review work but have no other relevant financial relationships to disclose.
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Funding
This manuscript was funded by Johnson & Johnson. The funder was involved in study design, data collection and analysis, decision to publish, and preparation of the manuscript.