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New anemia drug for MDS and myeloma patients shows early promise but trial halted

NCT ID NCT04582539

Disease control Sponsor: Incyte Corporation 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a daily pill called INCB000928 for people with anemia caused by myelodysplastic syndromes (MDS) or multiple myeloma. The goal was to see if it was safe and could raise red blood cell levels, reducing the need for transfusions. The trial was terminated early after enrolling only 22 participants, so we have limited information on how well it works.

What this could mean

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

Active substance
INCB000928
What this could lead to
If successful, this drug could help reduce or eliminate the need for blood transfusions in people with anemia from MDS or multiple myeloma.
What could go wrong
This was a very early (Phase 1/2) trial that was terminated before completion, so we have little data on safety or effectiveness. The drug may not work or could have side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

22 people

The number who actually took part.

Started

Aug 2021

Finished

Aug 2024

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: * Agreement to avoid pregnancy or fathering children. * Participants who are transfusion-dependent or present with symptomatic anemia For MDS participants: * Ineligible to receive or have not responded to available therapies for anemia such as ESAs or lenalidomide. * Not requiring cytoreductive therapy other than hydroxyurea. * BM and peripheral blood myeloblast count \< 10%. * Histologically confirmed diagnosis of the MDS, CMML and unclassifiable MDS/MPN overlap syndromes. For MM participants: * Histologically confirmed diagnosis of MM. * After failure of available standard treatments such as alkylating agents, glucocorticoids, immunomodulatory drugs (lenalidomide,pomalidomide, or thalidomide), proteasome inhibitors (bortezomib or carfilzomib), and daratumumab. Exclusion Criteria: * Any prior allogeneic stem cell transplantation or a candidate for such transplantation. * Any major surgery within 28 days before the first dose of study drug. * Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, or antibody or hypomethylating agent to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study drug. * Undergoing treatment with another investigational medication or having been treated with an investigational medication within 28 days before the first dose of study drug. -Undergoing treatment with ESAs, granulocyte colony-stimulating factor or granulocyte/macrophage colony-stimulating factor, romiplostin, or eltrombopag at any time within 28 days before the first dose of study drug. * Undergoing treatment with a strong or potent inhibitor or inducer of CYP3A4/5 within 28 days or 5 half-lives (whichever is longer) before the first dose of study drug or expected to receive such treatment during the study. * History of clinically significant or uncontrolled cardiac disease. * History or presence of an abnormal ECG that, in the investigator's opinion, is clinically Meaningful. * Presence of chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment. * Diagnosis of chronic liver disease.

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Conditions

The condition(s) this trial relates to.

anemia myelodysplastic syndrome Myelodysplastic Syndromes plasma cell myeloma

As listed by the trial registrant

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

Anemia Multiple myeloma Myelodysplastic syndromes

Contacts and locations

Locations

  • Azienda Ospedaliero-Universitaria Careggi (Aouc)

    Florence, 50134, Italy

  • Barbara Ann Karmanos Cancer Hospital

    Detroit, Michigan, 48201, United States

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093, France

  • Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

    Pavia, 27100, Italy

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310, France

  • Institut Gustave Roussy

    Villejuif, 94800, France

  • Irccs Istituto Clinico Humanitas

    Rozzano, 20089, Italy

  • L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138, Italy

  • Md Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Stanford Cancer Center

    Palo Alto, California, 94304, United States

  • Tulane Comprehensive Cancer Center

    New Orleans, Louisiana, 70112, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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