P-476: More efficient delivery of high-cost standard-of-care therapies in relapsed multiple myeloma using real-time feedback of patient-reported outcome measures: the MY-PROMPT-2 trial

Introduction: Many patients on the ANZ Myeloma and Related Diseases Registry (MRDR) stop standard-of-care (SoC) therapy prematurely. This impaired duration on therapy (DoT) reduces the potential survival benefit of the therapy. We hypothesise that if clinicians were made aware of emerging symptoms, DoT could be optimised with timely supportive care, which would enhance treatment effectiveness. MY-PROMPT-2 builds on our pilot MY-PROMPT randomized controlled trial (RCT) that confirmed the feasibility and acceptability of real-time patient reported outcome measure (PROM) feedback to clinicians. In patients with relapsed MM (RMM), receiving SoC lenalidomide (R), carfilzomib (K) or daratumumab (D)-based therapies, we aim to determine whether routine real-time PROMs feedback to clinicians at patient visits improves event-free survival (EFS: time from randomization to an event [permanent discontinuation of treatment, progression or death]) compared to patients on SoC alone.

Methods: This parallel, non-blinded, multicenter Bayesian RCT, uses 1:1 allocation, stratified by 3 SoC regimens (R, K, or D-based) and age with provision to recruit 200 adults.
Intervention: PROM results summary fed back to clinicians at monthly visits for 12 months. PROMs used:
• MyPOS: MM-specific, 30 items - symptoms/ mood/ healthcare support
• Additional regimen-specific questions (≤5) for common side effects of K, and D-based regimens
ePROM system: REDCap-based for easy implementation in routine care. PROMs are emailed to intervention patients 1 week before visits. Completion in clinic is also available. A PROM summary is emailed to the clinician, patient, and site staff.
PROMs to compare health-related quality of life (EORTC QLQ-C30) and treatment satisfaction (TSQM-9) between groups are collected 3-monthly in both arms for 12 months.
Novel statistical trial design: Once ≥60 events have been observed between the 2 arms, EFS monitoring comparing the intervention versus control arm, starts. Using pre-established criteria, if monitoring shows
• the intervention arm is inferior to controls, the trial will be stopped.
• the intervention arm is superior to controls, the Trial Management Committee can declare:
o Proof of concept (i.e. publish) - if statistical thresholds are met or
o Recommend further expansion of trial (subject to funding).
An economic evaluation will explore the cost-effectiveness of the new model of care.

Results: Recruitment has commenced and will be active at up to 15 sites.

Conclusions: This is the first registry-based multicenter trial in patients with RMM to test the benefit of real-time PROM reporting. The widely used ePROM platform facilitates translation into practice and the pragmatic trial design suits rare diseases allowing a smaller sample size to guide decisions to adopt real-time PROM reporting. Findings could be translatable to other cancers, chronic diseases and disease registries.