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Article History

Accepted: 2 November 2021

First Online: 25 November 2021

Declarations

:

: This work was supported by Janssen Pharmaceuticals and Legend Biotech.

: KW received honoraria from and served in a consulting or advisory role for Adaptive Biotechonlogies, Amgen, BMS, Celgene, GSK, Janssen, Karyopharm Therapeutics, Oncopeptides, Roche/Genentech, Sanofi, and Takeda, served in a consulting or advisory role for GSK, received travel funding from Amgen, BMS, Celgene, GSK, Janssen, and Takeda, and received research funding from Amgen, Celgene, Janssen, and Sanofi. TM served in a consulting or advisory role for GlaxoSmithKline and Juno Therapeutics, and received research funding from Amgen, Janssen, and Sanofi. AK served in a consulting or advisory role for Adaptive Biotechnologies, Celgene/Bristol Meyers-Squibb, GlaxoSmithKline, Janssen Oncology, Pfizer, and Regeneron, served on speakers bureaus for Amgen, Celgene/Bristol Meyers-Squibb, GlaxoSmithKline and Takeda, served on scientific advisory boards for Sutro Biopharma, has equity in Celgene/Bristol Meyers-Squibb, and received research funding from Janssen Oncology. SJ is a consultant for Bristol Myers Squibb, Janssen, Karyopharm Therapeutics, Merck, Sanofi, and Takeda Pharmaceuticals. SZU served in a consulting or advisory role for AbbVie, Amgen, Celgene, GlaxoSmithKline, Janssen, Karyopharm Therapeutics, Merck, Seattle Genetics, Skyline Diagnostics, and Takeda, served on speakers bureaus for Celgene, Janssen, Sanofi, and Takeda, and received research funding from Amgen, Array BioPharma, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, and Skyline Diagnostics. JGB served in a consulting or advisory role for Bluebird Bio, Bristol Myers Squibb, Celgene, CRISPR Therapeutics, Janssen, Karyopharm Therapeutics, Kite/Gilead, Legend Biotech, Secura Bio, Servier, and Takeda, and received research funding from AbbVie, Acetylon Pharmaceuticals, Amgen, Bluebird Bio, Bristol Myers Squibb, Celgene, Celularity, Constellation Pharmaceuticals, CURIS, EMD Serono, Genentech/Roche, Glenmark, Ichnos Sciences, Janssen, Kesios Therapeutics, Lilly, Novartis, Poseida, Sanofi, Takeda, Teva, and Vivolux. KY is a consultant physician and receives honoraria from Janssen, GSK, Amgen Inc., Takeda, and Sanofi and research funding from Janssen, Takeda, and Sanofi. AL, JMS, KQ, MV, AB, JD, SN and SV are employed by Janssen and have restricted stock units and/or stock options. AG and TN are employed by Legend Biotech, USA.

: The CARTITUDE-1 trial protocol was reviewed and approved by an independent ethics committee/institutional review board at all participating sites. All patients participating in the trial provided written informed consent. Similarly, the protocols of the clinical trials of daratumumab (POLLUX [], CASTOR [], and EQUULEUS []) were approved by local or independent institutional review board or ethics committees at participating sites and all patients provided written informed consent. The current analyses were conducted in accordance with a protocol and statistical analysis plan developed prior to the start of data analysis.

: Not applicable.

: Not applicable.

: Requests for access to the CARTITUDE-1 trial study data may be submitted through the Yale Open Data Access (YODA) Project site at. The data sharing policy of Janssen Pharmaceutical Companies is available at.

: Not applicable.

: All authors were responsible for the study conception and design. AL, KQ, and SN were responsible for acquisition and analysis. All authors were responsible for interpretation of the data and revising it critically.