Meaningful change in patient-reported outcomes after CAR-T for multiple myeloma: differences by race and ethnicity

This is the authors' abstract. We don't add key points for this paper.

Chimeric antigen receptor T-cell therapy (CAR-T) has revolutionized treatment for relapsed/refractory multiple myeloma (RRMM).In clinical trials and real-world practice, CAR-T remarkably improves progression-free and overall survival relative to other therapies.1-4 CAR-T trials also demonstrated meaningful improvements in patient-reported outcomes (PROs).5,6 PROs are health information reported directly by patients without interpretation by another person 7 and include health-related quality of life (HRQOL) and symptom burden.PROs are a high priority in the context of prolonged remission after CAR-T and are key outcomes in clinical trials.7 However, few real-world studies of patients with RRMM who received CAR-T have examined PROs, and no studies have evaluated differences by race and ethnicity, despite known disparities in MM incidence and care.8 This study compared meaningful changes in PROs among patients with RRMM receiving standard-of-care CAR-T by race and ethnicity using minimally important differences (MIDs), which represent the smallest numerical change that is meaningful for how patients feel.Advarra Institutional Review Board deemed the protocol exempt/low risk (protocol no.Pro00065891).Eligibility criteria were: (1) ≥18 years old, (2) scheduled for standard-of-care CAR-T for RRMM, (3) able to speak and read English or Spanish, (4) without psychiatric or neurologic diagnoses that could preclude participation, and (5) able to provide informed consent.Participants completed PROs electronically via Research Electronic Data Capture in English or Spanish (individual preference) prelymphodepleting chemotherapy (baseline) and 90 days after CAR-T (D90).Baseline was completed a median 6 of days prelymphodepleting chemotherapy (range, 1-91).The median window around D90 was 0 days (range, 0-4).Participants were compensated US $10 per assessment.Participants self-reported their demographics.Clinical characteristics, CAR-T information, and safety/ clinical outcomes were abstracted from medical records.This study was conducted in accordance with the Declaration of Helsinki.The 27-item Functional Assessment of Cancer Therapy-General (FACT-G) assessed overall HRQOL and 4 subscales: physical, social, emotional, and functional well-being.9 Higher scores indicated better HRQOL.Evidence-based thresholds were applied to identify clinically low individual scores (overall HRQOL ≤ 62, physical well-being ≤ 15, social well-being ≤ 16, emotional well-being ≤ 13, and functional well-being ≤ 11) and group-level averages (overall HRQOL ≤ 70, physical well-being ≤ 18, social well-being ≤ 19, emotional well-being ≤ 15, and functional well-being ≤ 14).MIDs were 4-point changes for overall HRQOL and 2-point changes for each subscale.10