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Open Label Single Arm Study to Assess the Implementation of Home Based Daratumumab Administration in Patients Being Treated for Multiple Myeloma
Background: Multiple myeloma (MM) is an incurable hematologic malignancy with a high burden of care for patients and their caregivers. While the treatment landscape for MM has evolved dramatically, the treatment burden remains high with frequent office visits for continual care. Innovative care deli...
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Published in: | Blood 2024-11, Vol.144, p.7596-7596 |
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Main Authors: | , , , , , , , |
Format: | Article |
Language: | English |
Online Access: | Get full text |
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Summary: | Background:
Multiple myeloma (MM) is an incurable hematologic malignancy with a high burden of care for patients and their caregivers. While the treatment landscape for MM has evolved dramatically, the treatment burden remains high with frequent office visits for continual care. Innovative care delivery models, such as administration of therapy at home, can potentially alleviate these burdens. Herein, we report on a trial of home-based administration of subcutaneous daratumumab and hyaluronidase-fihj (dara) for patients with MM.
Methods:
This is an open label single arm study to assess implementation of home administration of dara. The study took place from 12/09/2022 until 04/17/2024. Patients were eligible if they were receiving daratumumab monthly as either monotherapy or in combination with oral agents for MM. Participants received 8 cycles of dara (2 cycles in the infusion center, then 4 cycles at home, then 2 more cycles in the infusion center). The primary objective is patients' treatment satisfaction, assessed with the satisfaction with therapy (SWT)domain of theCancer Therapy Satisfaction Questionnaire (CTSQ), when they receive care at home as compared to standard of care (SOC) treatment in the infusion center. Secondary outcomes include adherence to home therapy, safety of home administration, barriers to home administration, quality of life (EORTC QLQ-30), financial burden (COST survey), and the other CTSQ domains. Surveys were completed at each monthly visit. Semi-structured qualitative interviews were conducted at the end of the study.
For the primary analysis, the SWT score was analyzed in a linear mixed effects model with a random effect of the patient and the fixed effect of the delivery mode (home vs. infusion center). Time trend (i.e. cycle), age, sex (female vs. male), and race (black vs. white) were also included as fixed effects, if significant. Mean difference in scores between home and infusion center were computed along with the 95% confidence interval (CI) and p value. The same approach was used for the secondary analysis of EORTC QLQ-30 (version 3), the COST survey, and the other CTSQ domains. Other secondary outcomes were analyzed with descriptive statistics. All analyses were performed with SAS 9.4 (SAS Institute Inc., Cary, NC). IRB approval was obtained.
Results:
We enrolled 20 participants with mean age of 66 years (range 49-89). Ten (50%) were female and 10 (50%) identified as black or African American. One patient withdrew |
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ISSN: | 0006-4971 |
DOI: | 10.1182/blood-2024-206031 |