Multiple Myeloma Clinical Trial

To Assess the Safety and Tolerability of INCB000928 in Participants With Myelodysplastic Syndromes or Multiple Myeloma.

Summary

This Phase 1/2, open-label, dose-finding study is intended to evaluate the safety and tolerability, PK, PD, and efficacy of INCB000928 administered as monotherapy in participants with MDS or MM who are transfusion-dependent or present with symptomatic anemia.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04582539

Recruitment Status:

Recruiting

Sponsor:

Incyte Corporation

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There are 14 Locations for this study

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Stanford Cancer Center
Palo Alto California, 94304, United States
University of Miami
Miami Florida, 33136, United States
Tulane Comprehensive Cancer Center
New Orleans Louisiana, 70112, United States
Barbara Ann Karmanos Cancer Hospital
Detroit Michigan, 48201, United States
University of Cincinnati
Cincinnati Ohio, 45219, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes , 44093, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud
Pierre Benite , 69310, France
Institut Gustave Roussy
Villejuif , 94800, France
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola ? Malpighi
Bologna , 40138, Italy
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Firenze , 50134, Italy
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia , 27100, Italy
Irccs Istituto Clinico Humanitas
Rozzano , 20089, Italy

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04582539

Recruitment Status:

Recruiting

Sponsor:


Incyte Corporation

How clear is this clinincal trial information?

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