Open label single arm study to assess the implementation of home based daratumumab administration in patients being treated for multiple myeloma.

Abstract

TPS1609 Background: Multiple myeloma (MM) is an incurable hematologic malignancy that has a high burden of care for patients and their caregivers. Over the last two decades, the treatment landscape for MM has changed dramatically. However, treatment burden with frequent visits to offices and the hospital is high. We need innovative care delivery models to alleviate these burdens. Chemotherapy at home remains uncommon in the US, though models for its use exist globally. In these models, home-based chemotherapy is safe, preferred by patients, and can be administered at lower cost. Herein, we propose a home-based subcutaneous daratumumab and hyaluronidase-fihj (dara) program for patients with MM. We hypothesize that this program will be feasible, reduce patient treatment and financial burden, and improve quality of life. Methods: We designed an open label single arm study to assess the implementation of home administration of dara. The primary objective is to evaluate (n=20) treatment satisfaction of patients, using the Cancer Therapy Satisfaction Questionnaire (CTSQ), when they receive care at home as compared to the standard of care (SOC). Secondary outcomes include evaluating adherence to home delivery, quality of life (EORTC QLQ-30), financial burden (COST survey), safety of home administration, and barriers to home administration. At the end of the study, we will conduct semi-structured interviews to assess patient experience with home administration of chemotherapy. Patients will be eligible for study participation if they have a diagnosis of multiple myeloma, are in the monthly phase of dara treatment and are treated with either monotherapy or in combination with oral agents. All participants who are interested and eligible will be on study for 8 cycles of dara (2 cycles of dara in the infusion center (IC) followed by 4 cycles at home and then 2 cycles in the IC). During the home administration phase, 1-3 days prior, patients will go to a local lab or have at home labs. On day of at home dara, the drug will be mixed and packaged by our pharmacy, and then delivered at room temperature to the patient’s home by our home infusion courier. The patient will take pre-medications 1-3 hours prior to nurse arrival. The nurse arrives, confirm pre-medications were taken. Pre-treatment vitals and post treatment vitals will be obtained. Drug will be administered as per label instructions. At the beginning of each cycle, patient reported outcome surveys and quality of life surveys will be collected. During the home administration phase, details on barriers to maintaining adherence (i.e. issues with storage, delivery, disposal of medication) will be collected. The study opened for enrollment on November 8th, 2022. As of February 1stth 2023, 9 patients have consented and 5 patients are on-treatment. Clinical trial information: NCT05511428 .