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Could a higher dose of reblozyl free MDS patients from frequent transfusions?

NCT ID NCT06045689

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether starting luspatercept (Reblozyl) at the maximum approved dose can help people with low-risk myelodysplastic syndromes (MDS) go without red blood cell transfusions for at least 8 weeks. About 106 participants who currently need regular transfusions will receive the drug. The main goal is to see if they can maintain higher hemoglobin levels without transfusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
luspatercept (Reblozyl)
What this could lead to
If successful, this could help people with low-risk MDS need fewer blood transfusions and maintain higher hemoglobin levels.
What could go wrong
This is an early-stage Phase 3 trial with only 106 participants. Results may not apply to all MDS patients, and side effects from luspatercept are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

106 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. * Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. * Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: * Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. * Participant has had a prior allogeneic or autologous stem cell transplant. * Participant has known history or diagnosis of AML. * Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

anemia myelodysplastic syndrome Myelodysplastic Syndromes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes

Contacts and locations

Locations

  • Local Institution - 0001

    Poitiers, Vienne, 86021, France

  • Local Institution - 0003

    Milwaukee, Wisconsin, 53226, United States

  • Local Institution - 0004

    Prague, Praha, Hlavní Mesto, 128 21, Czechia

  • Local Institution - 0005

    Barcelona, 08035, Spain

  • Local Institution - 0007

    Grenoble, 38 38043, France

  • Local Institution - 0008

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Local Institution - 0009

    Leipzig, Saxony, 04103, Germany

  • Local Institution - 0010

    Warsaw, Masovian Voivodeship, 02-172, Poland

  • Local Institution - 0011

    Detroit, Michigan, 48202, United States

  • Local Institution - 0013

    München, Bavaria, 81675, Germany

  • Local Institution - 0014

    Novara, Piedmont, 28100, Italy

  • Local Institution - 0015

    Pavia, Lombardy, 27100, Italy

  • Local Institution - 0016

    Leuven, Vlaams Brabant, 3000, Belgium

  • Local Institution - 0017

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • Local Institution - 0018

    Valencia, 46010, Spain

  • Local Institution - 0020

    Kansas City, Kansas, 66160-8500, United States

  • Local Institution - 0021

    Reggio Calabria, Calabria, 89124, Italy

  • Local Institution - 0022

    Huntsville, Texas, 77340-4101, United States

  • Local Institution - 0023

    Prague, Praha, Hlavní Mesto, 128 20, Czechia

  • Local Institution - 0024

    Florence, Tuscany, 50139, Italy

  • Local Institution - 0025

    Paducah, Kentucky, 42003-7915, United States

  • Local Institution - 0026

    Angers, 49933, France

  • Local Institution - 0027

    Ourense, 32005, Spain

  • Local Institution - 0028

    Salamanca, 37007, Spain

  • Local Institution - 0029

    Rozzano (MI), Milano, 20089, Italy

  • Local Institution - 0031

    Wheeling, West Virginia, 26003, United States

  • Local Institution - 0032

    New York, New York, 10029, United States

  • Local Institution - 0033

    New Haven, Connecticut, 06510, United States

  • Local Institution - 0034

    Katowice, 40-519, Poland

  • Local Institution - 0035

    Wałbrzych, 58-309, Poland

  • Local Institution - 0036

    Pittsburgh, Pennsylvania, 15224, United States

  • Local Institution - 0038

    Madrid, 28006, Spain

  • Local Institution - 0039

    Granada, 18014, Spain

  • Local Institution - 0040

    Hanover, Lower Saxony, 30161, Germany

  • Local Institution - 0041

    Nice, Alpes-Maritimes, 06202, France

  • Local Institution - 0043

    Amarillo, Texas, 79106-1781, United States

  • Local Institution - 0044

    Tour Cedex01, 37044, France

  • Local Institution - 0045

    Turin, Piedmont, 10128, Italy

  • Local Institution - 0046

    Paris, 75475, France

  • Local Institution - 0047

    San Juan, 00917, Puerto Rico

  • Local Institution - 0049

    Lódz, Lódzkie, 93-513, Poland

  • Local Institution - 0050

    Rome, Lazio, 00133, Italy

  • Local Institution - 0051

    Los Alamitos, California, 90720-3309, United States

  • Local Institution - 0052

    Barcelona, 08916, Spain

  • Local Institution - 0053

    Pierre-Bénite, 69495, France

  • Local Institution - 0054

    Eugene, Oregon, 97401-6043, United States

  • Local Institution - 0055

    St. Petersburg, Florida, 33705, United States

  • Local Institution - 0056

    Wellington, Florida, 33414, United States

  • Local Institution - 0058

    Morristown, New Jersey, 07960-6136, United States

  • Local Institution - 0059

    St Louis, Missouri, 63110, United States

  • Local Institution - 0062

    Naples, Campania, 80131, Italy

  • Local Institution - 0063

    Valencia, 46026, Spain

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