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.

View Eligibility Criteria

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT00761722

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 11 Locations for this study

See Locations Near You

California Cancer Care Inc
Greenbrae California, 94904, United States
Main Cancer Centers of Florida, P.A.
Ocoee Florida, 34761, United States
Indiana University School of Medicine
Indianapolis Indiana, 46202, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Northwest Cancer Specialists, P.C.
Albuquerque New Mexico, 87109, United States
Willamette Valley Cancer Institute
Springfield Oregon, 97477, United States
University of Texas- MD Anderson
Houston Texas, 77030, United States
Hematology and Oncology Assoc. of South Texas
San Antonio Texas, 78229, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Yakima Valley Memorial Hospital/ North Star Lodge
Yakima Washington, 98902, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT00761722

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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