Corticosteroid tapering is a safe approach in patients with relapsed or refractory multiple myeloma receiving subcutaneous daratumumab: part 3 of the open-label, multicenter, phase 1b PAVO study

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Acknowledgments

The authors would like to acknowledge the patients participating in this study and their families, the staff members at the study sites, the data and safety monitoring committees, and the staff members who were involved in data collection and analyses.

Author contributions

All authors developed the manuscript, provided a full review and approval of the final version of the article, and are fully responsible for all content and accuracy of the data.

Disclosure statement

HN has nothing to disclose.

SZU received research funding from Amgen, Array BioPharma, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX, and Takeda; consulted for Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Merck, Sanofi, SkylineDx, and Takeda; and served on speakers bureaus for Amgen, Celgene, Janssen, and Takeda.

M-VM served on speakers bureaus and advisory boards for AbbVie, Adaptive, Amgen, Celgene, GlaxoSmithKline, Janssen, Mundipharma, Oncopeptides, PharmaMar, Roche, Seattle Genetics, and Takeda.

NWCJvdD received research funding from Amgen, Bristol Myers Squibb, Cellectis, Celgene, Janssen, and Novartis; and consulted for Adaptive, Amgen, Bayer, Bristol Myers Squibb, Celgene, Janssen, Novartis, Servier, and Takeda.

AO consulted for Sanofi, GlaxoSmithKline, Amgen, Bristol Myers Squibb/Celgene, and Janssen.

TP served as an advisor for Janssen, Celgene, Takeda, Oncopeptides, Genentech, and AbbVie; and received research support from AbbVie, Janssen, Genmab, Celgene, Takeda, Oncopeptides, Genentech, and Roche.

NB, PH, and IN are employees of Janssen and hold equity in Johnson & Johnson.

BT holds equity in Johnson & Johnson and was an employee of Janssen at the time of the study.

DZ is an employee of Janssen.

AC consulted for Amgen, Antengene, Bristol Myers Squibb, Celgene, Janssen, Karyopharm, Novartis, Oncopeptides, Sanofi, Seattle Genetics, and Takeda; and received research funding from Amgen, Celgene, Janssen, Novartis, Pharmacyclics, Seattle Genetics, and Takeda.

PM received honoraria from and served as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen, and Sanofi.

Data-sharing statement

The data-sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through the Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.

Additional information

Funding

This study was sponsored by Janssen Research & Development, LLC [ClinicalTrials.gov Identifier: NCT02519452]. Medical writing and editorial support were provided by Austin Horton, PhD, and Kristin Runkle, PhD, of Lumanity Communications Inc., and were funded by Janssen Global Services, LLC.