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

Poitiers University Hospital

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma; Impaired Renal Function

Treatments: Drug: lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT00779922

REVIR

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

39 participants in 1 patient group

group 1 to 5

Experimental group

Treatment:

Drug: lenalidomide