OBJECTIVES: To understand methods implemented and topics collected as part of in-trial/exit interviews in clinical trial patients with multiple myeloma (MM) and related conditions.

METHODS: A targeted literature review was performed in October/November 2023 using keyword searches and handsearching/snowballing techniques to identify publications mentioning in-trial/exit interviews with patients with MM or related conditions in the past 10 years. Databases searched: MEDLINE®, American Society of Clinical Oncology, American Society of Hematology, International Society for Quality of Life Research, International Society for Pharmacoeconomics and Outcomes Research, and Drugs@FDA.

RESULTS: Of the 469 sources identified (440 articles/conference abstracts; 24 drug approval packages; 5 from handsearching/snowballing), 54 sources were fully reviewed. Of these, 10 sources contained information about in-trial/exit interviews in MM or related conditions (i.e., large B-cell lymphoma) from clinical trials: KarMMa (n=4; Phase 2, Europe/Canada/Japan/US), DREAMM-2 (n=3; Phase 2, Australia/Canada/Europe/US), CARTITUDE-1 (n=2; Phase 1b/2, Japan/US), and one source informing both TRANSCENDWORLD (Phase 2; Europe/Japan) and PLATFORM (n=1; Phase 1/2, US). All 10 sources were published in 2017 or 2018; interviews were optional, semi-structured using an interview guide, conducted in-person or via telephone, and in the patient’s native language (e.g., English, Spanish, French, German or Italian for DREAMM-2). Timing of interviews included a combination of pre-treatment, in-trial, exit, and/or post-treatment; interview topics included baseline signs/symptoms, meaningful change description for patient-reported outcome measures (PROMs), treatment impacts and expectations, treatment experience, health and wellbeing changes, treatment-related side effects/adverse events, and severity/bother of symptoms.

CONCLUSIONS: This review demonstrates that information collected from in-trial/exit interviews can inform study objectives and exploratory endpoints in clinical trials in MM, underscoring the value of these interviews when implemented alongside PROMs. Incorporating in-trial/exit interviews into clinical studies can provide important insights into many aspects of patients’ experiences and perceptions, and inform the overall benefit:risk profile of a novel investigational therapy.