Our project aims to identify metabolites and biomarkers associated with luspatercept-related asthenia in a prospective French study of low-risk MDS patients treated per EMA guidelines.
This is a prospective cohort of patients with MDS treated with luspatercept. The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.
Signed Written Informed Consent
Participants must be ≥ 18 years of age
IPSS-R : very low, low, or intermediate-risk disease
Less than 5% blasts (< 5%) (in bone marrow and < 1% PB blasts)
None
Single group
Luspatercept
DrugThe main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.
metabolites and biomarkers associated with luspatercept-related asthenia
Plasma biomarkers, including metabolites (energy metabolism, amino acids, lipid mediators), cortisol, iron-metabolism markers, serotonin, inflammatory cytokines, and selected exosomes derived microRNAs, will be explored, and associated with asthenia evaluated using CTCAE v 6.0. and PROs within the first 6 months of treatment with luspatercept. Fatigue will be graded as follows: * Grade 1: fatigue relieved by rest, * Grade 2: fatigue not relieved by rest, limiting instrumental ADL (activities of daily living) * Grade 3: fatigue not relieved by rest, limiting self-care ADL
Evolution of fatigue between luspatercept initiation and up to 6 months
Fatigue will be assessed over time through different ways: (i) EORTC QLQ C30 , assessed at baseline, Week6, Week12, Week18, Week24 (ii) pro-CTCAE (fatigue) , assessed weekly (iii) FACIT-F , assessed at baseline, Week6, Week12, Week18, Week24 (iv) AI-assisted evaluation of fatigue (Fidelio - chatbot): Fidelio will estimate the CTCAE grading, as well as the main treatment-related adverse events and their impact on daily life, as reported by patients. This will be collected continuously according to patient use of the chatbot, and reports will be produced on a weekly basis to the coordinator (v) CTCAE fatigue grading, assessed at baseline, Week6, Week12, Week18, Week24.
Metabolites and plasma biomarkers associated with response to luspatercept
Metabolites and plasma biomarkers will be the same as already described for the primary objective from V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5). The response to luspatercept will be measured using IWG 2018 criteria
CTCAE fatigue grading
CTCAE fatigue grading will be made by the investigator at baseline, Week6, Week12, Week18, Week24 and estimated by the chatbot Fidelio on a continuous basis (with weekly reports until 24 weeks). Investigators will be blinded to chatbot reports in order to limit bias in the estimation of agreement.
Satisfaction questionnaire about the chatbot
Adherence to the chatbot will be evaluated each week as (i) presence/absence of a discussion during the week, and (ii) time spent discussing with the chatbot. (iii) A satisfaction questionnaire of the chatbot will be proposed at the end of the trial on a scale from 0 to 10 (and several qualitative questions yes/no).
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