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 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 from the trial after cycle 2 and one patient came off trial for cycle 8 after significant treatment delays due to infectious complications. Nineteen completed the home infusion portion of the study. There was no significant change in the primary outcome (SWT) comparing home vs. the infusion center (mean difference 0.70 in favor of infusion center; 95% CI -3.02, 1.62; p=0.551). Treatment adherence at home was 100% and there were minimal delays in therapy (1/76 1.4%). No barriers to home administration were identified. There were no unique adverse events related to home administration. There were no unexpected adverse events related to medications.

There were no significant differences with the secondary outcomes. The EORTC QLQ-C30 mean difference comparing home to infusion center was 2.08 (p=0.405). Irrespective of site of treatment, we observed that females had significantly higher financial toxicity as compared to males (COST score: 7.37 points, p = 0.026). However, we did not observe any noticeable impact of the home administration on the COST score 0.18 (p-value: 0.812). Qualitative analysis will be reported separately.

Conclusions:

This pilot study demonstrated feasibility of home administration of dara. Among the population enrolled, patients had similar treatment satisfaction, quality of life, and financial burden with administration at home compared to the infusion center. Some of the slightly negative satisfaction with home treatment is likely related to logistical considerations and time the patient spent waiting between medication delivery and administration. Notably, women experienced higher financial toxicity as compared to men, which warrants future investigation to determine the cause. It is reassuring that no unexpected adverse events occurred with treatment at home. Findings support the conduct of larger trials to assess the impact of home-based oncologic therapy on patient and system outcomes.

Binder:karyopharm: Speakers Bureau; Janssen: Research Funding, Speakers Bureau. Porcu:SOBI: Consultancy, Honoraria, Speakers Bureau; ONO: Consultancy, Research Funding; Kiowa Kirin: Honoraria, Research Funding; Viracta therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Innate-Pharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; Teva: Consultancy, Research Funding; DAIICHI: Consultancy, Honoraria.