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MyelodysplasiaPhase 4LUSPAMARKNCT07830004

Plasmatic Biomarkers Associated With Short-term Luspatercept Treatment of Lower Risk Myelodysplastic Syndromes (MDS) Patients

A Phase 4 study testing Luspatercept in people with Myelodysplasia, run by University Hospital, Grenoble.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplasia
What is being tested?
Luspatercept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Nov 2026to Nov 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed Written Informed Consent
  • Participants must be ≥ 18 years of age
  • Type of Participant and Target Disease Characteristics:
  • Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification
  • IPSS-R : very low, low, or intermediate-risk disease
  • Less than 5% blasts (< 5%) (in bone marrow and < 1% PB blasts)
Show all 14Show fewer
  • Performance status: Eastern (ECOG) score of 0, 1, or 2
  • Anemic patients with Hb ≤10g/dL
  • First line therapy by luspatercept for lower risk MDS RS+ and MDS-RS- patients
  • Or Second line therapy by luspatercept for MDS-RS+ refractory or intolerant to prior ESA treatment, as defined by any one of the following:
  • Refractory to prior ESA treatment: documentation of nonresponse or response that was no longer maintained to prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF).
  • Intolerant to prior ESA treatment: Documentation of discontinuation of prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE
  • Patient or his entourage having a smartphone to load the application for Fidelio ( the chatbot)
  • Affiliated to SS

Who cannot join

  • Higher risk MDS, del 5q syndrome, MDS-RS-T, MD- CMML
  • Participant which has known clinically significant anaemia due to iron, vitamin B12, or folate deficiencies, iron deficiency anaemia or autoimmune haemolytic anaemia
  • Prior allogeneic or autologous stem cell transplant
  • Use of any of the following within 2-weeks prior to treatment:
  • Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days
  • Pregnancy
  • Psychiatric contraindications
  • Protected people according to articles L1121-5 à L1121-8 of CSP

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sophie Park, Pr contact

0033476765697

Spark@chu-grenoble.fr

About this study

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.

Conditions
Myelodysplasia
Being tested
Luspatercept
Keywords
fatigue evaluation under LUSPATERCEPT
Medical subject headings
Anemia, Refractory, with Excess of Blasts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LuspaterceptDrug

    The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.

Study groups in NCT07830004
Study groupRoleWhat they receive
LUSPATERCEPTOtherNot described
Receives: Drug: Luspatercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months of treatement

Secondary outcomes (5)

  1. 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.

    Measured: baseline, Week6, Week12, Week18, Week24

  2. 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

    Measured: V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5)

  3. 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.

    Measured: baseline, Week6, Week12, Week18, Week24 and weekly by chatbot up to 24 weeks

  4. 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).

    Measured: Weekly and at the end of the trial up to 24 weeks

  5. AE and grading according to CTCAE

    Patient reported AE and grading according to CTCAE will be collected at each 6 weeks visits

    Measured: baseline, Week6, Week12, Week18, Week24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMay 2031 (estimated)
  4. Study completionNov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07830004
Sponsor's protocol ID
38RC25.0319
Acronym
LUSPAMARK
Status last verified
Sep 2026
First submitted
4 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mathieu M, Friedrich C, Ducrot N, Zannoni J, Sylvie T, Jerraya N, Rousseaux S, Chuffart F, Kosmider O, Karim Z, Park S. Luspatercept (RAP-536) modulates oxidative stress without affecting mutation burden in myelodysplastic syndromes. Ann Hematol. 2022 Dec;101(12):2633-2643. doi: 10.1007/s00277-022-04993-7. Epub 2022 Oct 5.

    PubMed 36195681

  • Meunier M, Guttin A, Ancelet S, Laurin D, Zannoni J, Lefebvre C, Tondeur S, Persoons V, Pezet M, Pernet-Gallay K, Chuffart F, Rousseaux S, Testard Q, Thevenon J, Jouzier C, Deleuze JF, Laulagnier K, Sadoul R, Chatellard C, Hainaut P, Polack B, Cahn JY, Issartel JP, Park S. Extracellular vesicles from myelodysplastic mesenchymal stromal cells induce DNA damage and mutagenesis of hematopoietic stem cells through miRNA transfer. Leukemia. 2020 Aug;34(8):2249-2253. doi: 10.1038/s41375-020-0738-8. Epub 2020 Feb 12. No abstract available.

    PubMed 32051530

  • Jouzier C, Cherait A, Cony-Makhoul P, Hamel JF, Veloso M, Thepot S, Cluzeau T, Stamatoullas A, Garnier A, Guerci-Bresler A, Dimicoli-Salazar S, Pica GM, Cheze S, Santana C, Chermat F, Fenaux P, Park S. Red blood cell transfusion burden in myelodysplastic syndromes (MDS) with ring Sideroblasts (RS): A retrospective multicenter study by the Groupe Francophone des Myelodysplasies (GFM). Transfusion. 2022 May;62(5):961-973. doi: 10.1111/trf.16884. Epub 2022 Apr 22.

    PubMed 35452143

  • Raskovalova T, Jacob MC, Park S. Myelodysplastic Syndromes. N Engl J Med. 2020 Dec 24;383(26):2590. doi: 10.1056/NEJMc2032391. No abstract available.

    PubMed 33369362

  • Kaphan E, Laurin D, Lafeuillade B, Drillat P, Park S. Impact of transfusion on survival in patients with myelodysplastic syndromes: Current knowledge, new insights and transfusion clinical practice. Blood Rev. 2020 May;41:100649. doi: 10.1016/j.blre.2019.100649. Epub 2019 Dec 18.

    PubMed 31918886

  • Fenaux P, Platzbecker U, Mufti GJ, Garcia-Manero G, Buckstein R, Santini V, Diez-Campelo M, Finelli C, Cazzola M, Ilhan O, Sekeres MA, Falantes JF, Arrizabalaga B, Salvi F, Giai V, Vyas P, Bowen D, Selleslag D, DeZern AE, Jurcic JG, Germing U, Gotze KS, Quesnel B, Beyne-Rauzy O, Cluzeau T, Voso MT, Mazure D, Vellenga E, Greenberg PL, Hellstrom-Lindberg E, Zeidan AM, Ades L, Verma A, Savona MR, Laadem A, Benzohra A, Zhang J, Rampersad A, Dunshee DR, Linde PG, Sherman ML, Komrokji RS, List AF. Luspatercept in Patients with Lower-Risk Myelodysplastic Syndromes. N Engl J Med. 2020 Jan 9;382(2):140-151. doi: 10.1056/NEJMoa1908892.

    PubMed 31914241

  • Park S, Kosmider O, Maloisel F, Drenou B, Chapuis N, Lefebvre T, Karim Z, Puy H, Alary AS, Ducamp S, Verdier F, Bouilloux C, Rousseau A, Jacob MC, Debliquis A, Charpentier A, Gyan E, Anglaret B, Leyronnas C, Corm S, Slama B, Cheze S, Laribi K, Ame S, Rose C, Lachenal F, Toma A, Pica GM, Carre M, Garban F, Mariette C, Cahn JY, Meunier M, Herault O, Fenaux P, Wagner-Ballon O, Bardet V, Dreyfus F, Fontenay M. Dyserythropoiesis evaluated by the RED score and hepcidin:ferritin ratio predicts response to erythropoietin in lower-risk myelodysplastic syndromes. Haematologica. 2019 Mar;104(3):497-504. doi: 10.3324/haematol.2018.203158. Epub 2018 Oct 4.

    PubMed 30287621

  • Della Porta MG, Garcia-Manero G, Santini V, Zeidan AM, Komrokji RS, Shortt J, Valcarcel D, Jonasova A, Dimicoli-Salazar S, Tiong IS, Lin CC, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman KL, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Sep;11(9):e646-e658. doi: 10.1016/S2352-3026(24)00203-5. Epub 2024 Jul 19.

    PubMed 39038479

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Luspatercept in people with Myelodysplasia, run by University Hospital, Grenoble.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sophie Park, Pr (0033476765697, Spark@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

metabolites and biomarkers associated with luspatercept-related asthenia (time frame: 6 months of treatement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07830004, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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