Status:
COMPLETED
Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function
Lead Sponsor:
Poitiers University Hospital
Conditions:
Multiple Myeloma
Impaired Renal Function
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the pharmacokinetic profile of Revlimid® in patients presenting with Multiple Myeloma and impaired renal function, the safety of Revlimid® in the enrolled pat...
Eligibility Criteria
Inclusion
- Documented diagnosis of relapsed or refractory multiple myeloma (MM).
- Age \> 18 years at the time of signing the informed consent form
- Stable renal function
Exclusion
- Documented amyloidosis
- Any prior use of Revlimid ®
- Any contraindication to Revlimid ® and especially:
- Lack of acceptable method of birth control for female of childbearing potential (FCPB)
- Men who don't agree to use condom during the study and 4 weeks after the last study drug intake if their partner is a FCPB.
- Pregnant or breast feeding women
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00779922
Start Date
November 1 2008
Last Update
October 11 2016
Active Locations (1)
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1
Poitiers University Hospital
Poitiers, France, 86000