PSYCHOMETRIC PROPERTIES OF THE MULTIPLE MYELOMA SYMPTOM AND IMPACT QUESTIONNAIRE (MYSIM-Q) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): ANALYSIS OF THE MAJESTEC-3 STUDY
Author(s)
Eva G. Katz, MD1, Katharine Gries, PhD1, Kai Fai Ho, PhD2, Kristen Lantz, PhD3, Weili Sun, MD, PhD4, Rahul Banerjee, MD5;
1Johnson & Johnson, Raritan, NJ, USA, 2STAT-TU, Elora, ON, Canada, 3Johnson & Johnson, Spring House, PA, USA, 4Johnson & Johnson, Los Angeles, CA, USA, 5Division of Hematology & Oncology, University of Washington, Seattle, WA, USA
1Johnson & Johnson, Raritan, NJ, USA, 2STAT-TU, Elora, ON, Canada, 3Johnson & Johnson, Spring House, PA, USA, 4Johnson & Johnson, Los Angeles, CA, USA, 5Division of Hematology & Oncology, University of Washington, Seattle, WA, USA
OBJECTIVES: MySIm-Q is a patient-reported outcome (PRO) instrument that measures symptoms and impacts in patients with multiple myeloma. Validation and assessment of psychometric properties of the MySIm-Q symptom score are described using a clinical trial sample of patients with RRMM.
METHODS: MySIm-Q includes 17 items addressing 5 symptom domains (pain, neuropathy, fatigue, digestive, cognitive) and 3 impact domains (activity, social, emotional) using symptom and impact subscales. Recall period is the "past 7 days", with responses reported on a 5-point verbal rating scale. Following an evaluation framework for PRO measurement properties, the symptom score was assessed through internal consistency, test-retest reliability, concurrent validity, and known-groups validity. Meaningful within-patient change was assessed through anchor-based and distribution-based methods. The analysis used pooled data from MajesTEC-3, a phase 3 study investigating teclistamab/daratumumab versus standard-of-care therapy in RRMM.
RESULTS: 541 patients completed MySIm-Q assessments. The internal consistency estimate for MySIm-Q symptom score (Cronbach’s α-coefficient, 0.77) exceeded the predefined threshold (≥0.70). Correlations between each item and its hypothesized scale exceeded 0.4 for all items, meeting criteria for item-level convergent validity. Known-groups validity of total symptom score was established through multiple hypotheses. Total symptom score detected improvement and worsening in conditions based on multiple definitions. Threshold for minimum improvement (assessed by PGIS) was met by 43/154 (27.9%) patients with no symptom change and 60/119 (50.4%) patients with a 1-category symptom improvement. Threshold for worsening was met by 19/154 (12.3%) patients with no symptom change and 22/41 (53.7%) patients with a 1-category symptom worsening.
CONCLUSIONS: Aligning with previous analysis of MySIm-Q measurement properties (Mateos MV, et al. Value Health. 2024;27(6):S320), our analysis provides additional evidence that 1) MySIm-Q is a reliable, valid, fit-for-purpose instrument that can detect changes in myeloma symptoms and 2) total symptom score can detect symptom changes with RRMM therapies, including bispecific antibodies.
METHODS: MySIm-Q includes 17 items addressing 5 symptom domains (pain, neuropathy, fatigue, digestive, cognitive) and 3 impact domains (activity, social, emotional) using symptom and impact subscales. Recall period is the "past 7 days", with responses reported on a 5-point verbal rating scale. Following an evaluation framework for PRO measurement properties, the symptom score was assessed through internal consistency, test-retest reliability, concurrent validity, and known-groups validity. Meaningful within-patient change was assessed through anchor-based and distribution-based methods. The analysis used pooled data from MajesTEC-3, a phase 3 study investigating teclistamab/daratumumab versus standard-of-care therapy in RRMM.
RESULTS: 541 patients completed MySIm-Q assessments. The internal consistency estimate for MySIm-Q symptom score (Cronbach’s α-coefficient, 0.77) exceeded the predefined threshold (≥0.70). Correlations between each item and its hypothesized scale exceeded 0.4 for all items, meeting criteria for item-level convergent validity. Known-groups validity of total symptom score was established through multiple hypotheses. Total symptom score detected improvement and worsening in conditions based on multiple definitions. Threshold for minimum improvement (assessed by PGIS) was met by 43/154 (27.9%) patients with no symptom change and 60/119 (50.4%) patients with a 1-category symptom improvement. Threshold for worsening was met by 19/154 (12.3%) patients with no symptom change and 22/41 (53.7%) patients with a 1-category symptom worsening.
CONCLUSIONS: Aligning with previous analysis of MySIm-Q measurement properties (Mateos MV, et al. Value Health. 2024;27(6):S320), our analysis provides additional evidence that 1) MySIm-Q is a reliable, valid, fit-for-purpose instrument that can detect changes in myeloma symptoms and 2) total symptom score can detect symptom changes with RRMM therapies, including bispecific antibodies.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
MSR15
Topic
Methodological & Statistical Research
Topic Subcategory
PRO & Related Methods
Disease
SDC: Oncology, STA: Multiple/Other Specialized Treatments