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Trial ID: NCT04582539
A Phase 1/2, Open-Label, Multicenter Study of INCB000928 Administered as a Monotherapy in Participants With Anemia Due to Myelodysplastic Syndromes or Multiple Myeloma
- 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
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.
- Any prior allogeneic stem cell transplantation or a candidate for such
- 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
- Presence of chronic or current active infectious disease requiring systemic
antibiotic, antifungal, or antiviral treatment.
- Diagnosis of chronic liver disease.
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Joanna Denise De Vore