Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)
Category: Treatment of Newly Diagnosed Myeloma (excluding t-cell redirection therapy)
Evaluating a Value-Based, Measurable Residual Disease (MRD) - Focused Clinical Pathway in Patients with Newly Diagnosed Multiple Myeloma
C. Anthony Blau, MD (he/him/his)
Founder and CEO
All4Cure
Widespread variation in myeloma treatment adversely affects patient outcomes. All4Cure is a collaborative ecosystem for oncology of patients, clinicians and researchers that developed a clinical pathway for NDMM to achieve and maintain MRD negativity.
This report describes an observational cohort study that examines the outcomes of NDMM patients treated On- vs. Off-Pathway, and an interim analysis following accrual of 225 patients (out of 450), focusing on baseline demographic, clinical and treatment characteristics.
Methods:
Data were collected retrospectively from electronic medical records of NDMM patients initiating treatment at community oncology practices ≥4/18/2024. Patients were classified into three cohorts: On-Pathway Platform (enrolled in All4Cure, n=10), On-Pathway Documentation (pathway available via All4Cure’s website, n=128), and Off-Pathway (n=87), using a pathway adherence scoring system that includes use of an anti-CD38 antibody in front-line treatment. Baseline demographics, clinical characteristics, and comorbidities were compared. Therapy regimens and treatment sequences were also analyzed.
Results:
Median age at diagnosis was 68 years; 141 (63%) were male, 147 (65.3%) were white and 34 (15.1%) were black. No significant demographic differences between cohorts were observed. Sixty percent of Platform patients, and 77.3% of Documentation patients were eligible for transplant vs. 59.8% in Off-Pathway (p=0.018). Other clinical characteristics (e.g. subtype, cytogenetics) were similar across groups. The most common comorbidities were hypertension (n=162, 72%), renal disease (n=93, 41.3%), and diabetes (n=50, 22.2%), without significant differences between cohorts.
Front-line treatment included 15 distinct regimens. Nearly half of patients (46% overall, 53.5% for combined On-Pathway cohorts vs. 34.5% for Off-Pathway cohort p=0.0066) were treated with a 4-drug regimen (anti-CD38 antibody, IMID, proteasome inhibitor and dexamethasone). Three-drug regimens with lenalidomide, bortezomib and dexamethasone were used in 14.6% overall (2.3% On-Pathway vs. 33.3% Off-Pathway, p< 0.0001), and 2-drug regimens containing lenalidomide or bortezomib plus dexamethasone were used in 2.8% overall (0.8% On-Pathway vs. 6% Off-Pathway, p=0.0363). The group differences are an expected consequence of the pathway adherence scoring.
Conclusions:
This real-world study showed no difference in most demographic and clinical characteristics across cohorts defined by adherence to a clinical pathway. Wide variability in front-line treatment was observed, with fewer than half of patients receiving the current 4-drug standard of care. Consistent with the study design, On-Pathway patients were 55% more likely to receive an anti-CD38 based quadruplet regimen. As follow-up data accrue, this study will assess whether clinical pathway adherence leads to improved MRD-negativity and other effectiveness outcomes in patients treated at community oncology centers.