Early outpatient palliative care for patients with multiple myeloma: A randomized pilot study.

12051 Background: Early palliative care is recommended for patients with advanced or incurable cancer. Despite these recommendations, patients with multiple myeloma are often referred late to palliative care, or not at all. We assessed the feasibility of an early outpatient palliative care intervention for patients with multiple myeloma. Methods: English-speaking adults (≥18 years) with newly-diagnosed or relapsed multiple myeloma and at least one symptom scored ≥3/10 on the revised version of the Edmonton Symptom Assessment System (with constipation and sleep added, ESAS-rCS) were recruited from multiple myeloma outpatient clinics at the Princess Margaret Cancer Centre, Toronto, Canada. Participants were randomized to routine outpatient care from their multiple myeloma team (usual care arm), or to monthly in-person or virtual interdisciplinary outpatient palliative care clinic visits for 3 months alongside usual multiple myeloma care (intervention arm). The primary outcome was feasibility (recruitment of 40 patients/12 months; ≥60% completion of patient-reported outcome measures monthly for 3 months; ≥60% of those randomized to the intervention arm attending ≥1 palliative care clinic visit). Exploratory efficacy outcomes were measured at 1-, 2- and 3-months (primary endpoint), including quality of life (FACIT-Pal, primary efficacy outcome), symptom burden (ESAS-rCS), mood (PHQ-9) and satisfaction with care (FAMCARE-P16). Results: Of 40 patients recruited within 12 months (median age 66.5 years [range 33-92]; 17 [42.5%] female), 21 were randomized to the intervention arm and 19 to usual care. The 1-, 2- and 3-month completion rates among all participants for all measures were 37/39 (94.9%), 36/39 (92.3%), and 33/38 (86.8%), respectively; one intervention arm participant withdrew and one died during the study period. In the intervention arm, 17/21 (80.9%) attended at least one palliative care clinic visit; in the usual care arm, 3/19 (15.8%) were referred to the palliative care clinic during the study period. The mean difference (B) in change in the FACIT-Pal total score at 3-months from baseline between the intervention and usual care arm was 15.5 (standard error [SE] 8.8, p=0.09) after adjusting for baseline scores. The change in ESAS-rCS total distress scores at 3-months was improved in the intervention arm compared with usual care (adj. B=-13.7 [SE 5.4], p=0.02]), as were individual symptom scores for drowsiness (adj. B=-2.1 [SE 0.9], p=0.02), constipation (adj. B=-2.1 [SE 1.0], p=0.03) and sleep (adj. B=-3.6 [SE 0.8], p=0.0002). Changes in PHQ-9 and FAMCARE-P16 total scores at 3-months did not differ between study arms. Conclusions: This pilot trial demonstrated that a larger randomized controlled trial of early palliative care versus usual care for patients with multiple myeloma is feasible. Preliminary results are encouraging for improvements in symptom burden and quality of life. Clinical trial information: NCT06485076 .