Status and phase
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About
The purpose of this study is to investigate if the combination of CC-486 with lenalidomide and radiation therapy is a safe and effective treatment for plasmacytoma.
Enrollment
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Volunteers
Inclusion criteria
Cohort 1: Must meet all the following 3 criteria:
Cohort 2: Must meet all the following criteria:
All Cohorts:
Recommendation is for 2 effective contraceptive methods during the study and for at least 6 months after the last dose. Adequate forms of contraception are double-barrier methods (condoms with spermicidal jelly or foam and diaphragm with spermicidal jelly or foam), oral, depo provera, or injectable contraceptive, intrauterine devices, and tubal ligation.
Refrain from semen or sperm donation while taking IP and for at least 90 days after the last dose of IP.
Exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
NYHA class 4 CHF Unstable angina Myocardial infarction
Primary purpose
Allocation
Interventional model
Masking
21 participants in 1 patient group
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Central trial contact
Alexander Lesokhin, MD; Urvi Shah, MD
Data sourced from clinicaltrials.gov
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