Pharmacokinetics of Lenalidomide (Revlimid®) in Patients With Multiple Myeloma and Impaired Renal Function

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 patients population.

and evaluate the efficacy of Revlimid®-Dexamethasone combination in patients presenting MM and impaired renal function at completion of 3 cycles of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poitiers University Hospital
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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