A Phase 4 interventional study of Luspatercept in Myelodysplasia, sponsored by University Hospital, Grenoble. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University Hospital, Grenoble · Phase 4, Interventional, and Treatment
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.
Type of Participant and Target Disease Characteristics:
Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification
Or Second line therapy by luspatercept for MDS-RS+ refractory or intolerant to prior ESA treatment, as defined by any one of the following:
Exclusion critéria:
Use of any of the following within 2-weeks prior to treatment:
Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days
Drug: 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.
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
Time frame: 6 months of treatement
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.
Time frame: 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
Time frame: V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5)
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.
Time frame: baseline, Week6, Week12, Week18, Week24 and weekly by chatbot up to 24 weeks
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).
Time frame: Weekly and at the end of the trial up to 24 weeks
AE and grading according to CTCAE
Patient reported AE and grading according to CTCAE will be collected at each 6 weeks visits
Time frame: baseline, Week6, Week12, Week18, Week24
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble