Abstract
Purpose
The phase III COLUMBA study evaluated daratumumab (DARA) intravenous (IV) and subcutaneous (SC) in patients with relapsed or refractory multiple myeloma. Here, we report patient-reported satisfaction with therapy (SWT) in COLUMBA.
Methods
DARA IV or DARA SC was administered weekly (cycles 1–2), every 2 weeks (cycles 3–6), and every 4 weeks (cycles 7 +). Patients completed a modified version of the Cancer Therapy Satisfaction Questionnaire (CTSQ) at weekly (cycles 1–2) and monthly (cycles 3 +) intervals and at the end of treatment. Results for each item and the SWT domain score were summarized using descriptive statistics. The distribution of responses for individual items was calculated for each assessment. The proportion of patients for whom SWT domain score change from first assessment met or exceeded the minimally important difference (MID) of 5.9 points was calculated at each assessment time point.
Results
Two-hundred fifty-nine patients were randomized to DARA IV and 263 to DARA SC. Mean scores for SWT domain questions were high and largely positive during treatment. Responses indicating positive perceptions of therapy were given by a numerically greater proportion of patients in the DARA SC group than the DARA IV group for most questions. Changes from the first assessment in SWT domain scores met or exceeded the MID for an average of ~ 40% of patients.
Conclusion
In COLUMBA, modified CTSQ results suggest patients in the DARA SC group were more satisfied with their cancer therapy than those in the DARA IV group.
Trial registration
ClinicalTrials.gov identifier NCT03277105. Registered September 8, 2107.
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Code availability
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Acknowledgements
The authors and Janssen thank the patients who participated in this study, the staff members at the study sites, the data and safety monitoring committees, and the staff members involved in data collection and analyses. This study (ClinicalTrials.gov identifier NCT03277105) was funded by Janssen Research & Development, LLC. Editorial and medical writing support was provided by Corey Eagan, MPH, of Eloquent Scientific Solutions and was funded by Janssen Global Services, LLC.
Funding
This study (ClinicalTrials.gov identifier NCT03277105) was funded by Janssen Research & Development, LLC. Editorial and medical writing support was provided by Corey Eagan, MPH, of Eloquent Scientific Solutions and was funded by Janssen Global Services, LLC.
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Conception and design: all authors. Provision of study materials or patients: SZU, M-VM, VH, SI, NJB, HN, HM, MC, CH, DW, VS. Collection and assembly of data: JF, MS, CH, XQ, HP, TM, KL, KSG. Manuscript writing: all authors. Final approval of manuscript: all authors. Accountable for all aspects of the work: all authors.
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Conflict of interest
SZU received research funding from Amgen, Array Biopharma, Bristol-Myers Squibb, Celgene, Janssen Pharmaceuticals, Merck, Pharmacyclics, Sanofi, and Takeda; consulted for Amgen, Bristol-Myers Squibb, Celgene, Janssen Pharmaceuticals, Merck, SkylineDx, and Takeda; and served on speakers bureaus for Amgen, Celgene, Janssen Pharmaceuticals, Sanofi, and Takeda. M-VM received honoraria from Adaptive Biotechnologies, Amgen, Celgene, Janssen Pharmaceuticals, and Takeda; served on the Board of Directors or advisory committees for AbbVie, Amgen, Celgene, GenTech, GlaxoSmithKline, Janssen Pharmaceuticals, Mundipharma, PharmaMar, Roche, and Takeda; served on data and monitoring committees for Amgen and Janssen Pharmaceuticals; and served on speakers bureaus for Amgen, Celgene, Janssen Pharmaceuticals, and Takeda. VH consulted and served on speakers bureaus for, and received honoraria from, Amgen, Bristol-Myers Squibb, Celgene, Janssen Pharmaceuticals, and Takeda. SI received honoraria and research funding from Bristol-Myers Squibb, Celgene, Daiichi Sankyo, Janssen Pharmaceuticals, Ono, Sanofi, and Takeda; and research funding from AbbVie, Chugai, Kyowa Kirin, and Merck Sharp & Dohme. NJB consulted for and received honoraria from AbbVie, Amgen, Celgene, Janssen Pharmaceuticals, and Takeda. MC consulted for AbbVie, Amgen, Celgene, and Janssen Pharmaceuticals; received honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen Pharmaceuticals, and Takeda; and served on speakers bureaus for and received travel and/or accommodation expenses from Celgene and Janssen Pharmaceuticals. CH received honoraria from AbbVie, Amgen, and Celgene. DW consulted for and received honoraria from Amgen, Celgene, Janssen Pharmaceuticals, Sanofi, and Takeda. VDS served on advisory boards for Amgen, Celgene, Janssen-Cilag, and Novartis. JF, MS, CH, XQ, HP, TM, KL, and KSG are employees of Janssen Pharmaceuticals. HN and HM have no conflicts to disclose.
Ethical approval
The COLUMBA study was done in accordance with the principles of the Declaration of Helsinki, International Conference on Harmonisation Guideline for Good Clinical Practice, and applicable region-specific regulatory requirements. Study protocol and amendments were reviewed by independent ethics committees and institutional review boards at each center.
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Usmani, S.Z., Mateos, MV., Hungria, V. et al. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol 147, 619–631 (2021). https://doi.org/10.1007/s00432-020-03365-w
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DOI: https://doi.org/10.1007/s00432-020-03365-w