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Clinical Trial
. 2022 Dec;9(12):e897-e905.
doi: 10.1016/S2352-3026(22)00284-8. Epub 2022 Oct 7.

Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study

Thomas Martin  1 , Yi Lin  2 , Mounzer Agha  3 , Adam D Cohen  4 , Myo Htut  5 , A Keith Stewart  6 , Parameswaran Hari  7 , Jesus G Berdeja  8 , Saad Z Usmani  9 , Tzu-Min Yeh  10 , Yunsi Olyslager  11 , Jenna D Goldberg  10 , Jordan M Schecter  10 , Deepu Madduri  10 , Carolyn C Jackson  10 , William Deraedt  11 , Katharine S Gries  10 , John M Fastenau  10 , Jeremiah J Trudeau  10 , Muhammad Akram  12 , Lida Pacaud  12 , Andrzej Jakubowiak  13 , Sundar Jagannath  14
Affiliations
Clinical Trial

Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study

Thomas Martin et al. Lancet Haematol. 2022 Dec.

Abstract

Background: CARTITUDE-1 is a phase 1b-2 study evaluating ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, in patients with relapsed or refractory multiple myeloma. Primary efficacy outcomes have previously been reported. Here, we report health-related quality of life (HRQOL) secondary outcomes evaluated using patient-reported outcomes.

Methods: This single-arm, open-label, phwase 1b-2 study was done at 16 centres in the USA. Patients were aged 18 years or older with diagnosis of multiple myeloma and Eastern Cooperative Oncology Group performance status of 1 or less with three or more previous lines of therapy, or were double refractory to a proteasome inhibitor and immunomodulatory drug, and had received a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody. A single cilta-cel infusion (target dose 0·75 × 106 CAR+ T cells per kg) was administered 5-7 days after lymphodepletion. Patient-reported outcomes were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire core 30-item, pre-specified items from the EORTC myeloma module, and EuroQol five-dimensional descriptive system questionnaire. Clinically meaningful changes in patient-reported outcomes were defined by anchor-based minimally important differences. This trial is registered with ClinicalTrials.gov, NCT03548207. This trial is completed but feeding into a long-term follow-up study.

Findings: Between July 16, 2018, and Oct 7, 2019, 78 patients were enrolled and underwent apheresis in phase 2 of the study. 68 patients were treated (43 [63%] male, 49 [72%] White), and their patient-reported outcomes assessed (median follow-up 16·9 months, IQR 15·7-17·5). After infusion, a transient decline was observed, followed by improvements in global health status (mean change from baseline to day 464 +8·0 points, SD 20·9), physical (+4·6 points, 21·1), and emotional functional scales (+1·9 points, 23·7) over time, and declines for symptom-based scores (-14·1 pain, SD 31·5 and -15·4 fatigue; SD 29·5), indicating improved patient HRQOL following treatment with cilta-cel.

Interpretation: These durable HRQOL improvements are consistent with clinical findings, in which a single cilta-cel infusion led to substantial and durable responses in heavily pre-treated patients with relapsed or refractory multiple myeloma. These results support the use of cilta-cel in patients with relapsed or refractory multiple myeloma.

Funding: Janssen Research & Development and Legend Biotech USA.

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Conflict of interest statement

Declaration of interest TM receives research funding from Janssen. YL is a consultant for Bluebird Bio, Celgene/BMS, Fosun Kite, Gamida Cells, Iovance, Janssen, Juno/BMS, Kite/Gilead, Legend Biotech, Novartis, Pfizer, Takeda, and Vineti; receives research funding from Bluebird Bio, Celgene/BMS, Janssen, Kite/Gilead, Merck, Takeda Pharmaceuticals, Legend Biotech, and Boston Scientific; and has participated in a data safety monitoring board or advisory board for NexImmune, Pfizer, and Sorrento. ADC reports personal fees from AstraZeneca, Bristol Myers Squibb/Celgene, Genentech/Roche, Janssen, Kite Pharma, Oncopeptides, Seattle Genetics, and Takeda and personal fees and grants from GlaxoSmithKline and Novartis. MH is a current employee of City of Hope Medical Center. AKS receives honoraria from Amgen, Aventis, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Oncopeptides, and Sanofi and serves in a leadership or fiduciary role for Genomics England and Tempus. PH receives consulting fees and honoraria from AbbVie, Bristol Myers Squibb, Celgene, Janssen, Kite, Sanofi Genzyme, Spectrum, and Takeda Pharmaceuticals and receives research funding from Amgen, Bristol Myers Squibb, Celgene, Sanofi Genzyme, and Spectrum. JGB receives research funding from AbbVie, Acetylon, Amgen, Bluebird, Bristol Myers Squibb, Celgene, Cellularity, Constellation, CRISPR Therapeutics, CURIS, Eli Lilly and Company, EMD Serono, Genentech, Glenmark, Janssen, Kesios, Novartis, Poseida, Takeda Pharmaceuticals, Teva, and Vivolux and is a consultant for Amgen, Bioclinica, Bristol Myers Squibb, Celgene, CRISPR Therapeutics, Janssen, Karyopharm, Kite Pharma, Legend, Prothena, SecuraBio, Servier, and Takeda Pharmaceuticals. SZU is a consultant for AbbVie, Amgen, Array Biopharma, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Merck, Sanofi, Seattle Genetics, SkylineDX, and Takeda Pharmaceuticals; receives honoraria from Amgen, Bristol Myers Squibb, Celgene, Janssen, MundiPharma, Pharmacyclics, Sanofi, and Takeda Pharmaceuticals; and receives research funding from Amgen, Array Biopharma, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Incyte, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX, and Takeda Pharmaceuticals. T-MY, YO, JDG, JMS, WD, KSG, JMF, and JJT are employed by Janssen. DM is a consultant for GlaxoSmithKline, Sanofi, Janssen, Celgene, BMS, and Takeda; receives honoraria from GlaxoSmithKline, Sanofi, Janssen, Celgene, BMS, and Takeda; and has received research funding from Janssen. CCJ is employed by Janssen and is a consultant physician at the Memorial Sloan Kettering Cancer Center. MAk and LP are employed by Legend Biotech. AJ receives consulting fees and honoraria from AbbVie, Adaptive, Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Juno, Karyopharm, and Sanofi and serves in a leadership or fiduciary role for AbbVie, Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Karyopharm, and Sanofi. SJ is a consultant for Bristol Myers Squibb, Janssen, Karyopharm Therapeutics, Legend Biotech, Merck, Sanofi, and Takeda Pharmaceuticals; participates in a data safety monitoring board or advisory board for DMC; and serves in a leadership or fiduciary role for ASH, IMS, and SOHO. MAg declares no competing interests.

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