Multiple Myeloma Clinical Trial
Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma
Summary
The purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.
Eligibility Criteria
Inclusion Criteria:
18 years or older
Diagnosis of MDS or CMML
Diagnosis of AML, Multiple myeloma, Hodgkin's or Non-Hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective
ECOG Performance Status 0-2
Use of acceptable birth control
Standard safety inclusion for serum creatinine, AST, ALT, bilirubin
Serum bicarbonate greater than or equal to 20 mEq/L
Platelet count greater than or equal to 25,000/uL
Hemoglobin greater than or equal to 500/uL
Signed informed consent
Exclusion Criteria:
Diagnosis of acute promyelocytic leukemia
Treatment with demethylating agents within 21 days prior to Cycle 1, Day 1
Treatment with any anticancer therapy (standard or investigational) within 21 days prior to Cycle 1, Day 1 or ongoing adverse events from previous treatment
Hypersensitivity to azacitidine or mannitol
Active, uncontrolled infection
Presence of GI disease, malignant tumors or other conditions known to interfere with ADME
Known or active HIV, viral hepatitis B or C
Breastfeeding or pregnant females
Current or uncontrolled cardiac disease
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There are 11 Locations for this study
Greenbrae California, 94904, United States
Ocoee Florida, 34761, United States
Indianapolis Indiana, 46202, United States
Kansas City Kansas, 66160, United States
Saint Louis Missouri, 63110, United States
Albuquerque New Mexico, 87109, United States
Springfield Oregon, 97477, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Seattle Washington, 98109, United States
Yakima Washington, 98902, United States
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